102 Medidata Jobs

Description Sr Clinical Programmer (Veeva/ Rave+ Custom Function) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. Generates andmaintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design,write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. Reviews and provide input on study budgets and monitors scope of work to actual work, alerting managementof potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. Performs system integration activities, application updates, and user acceptance testing. Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. Assists in project meetings and actively contributes and participates in departmental review meetings. Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. Manages project resources, proactively alerting management of delivery and resourcing needs. Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. Qualifications Bachelor’s degree preferred, or equivalent combination of related education and experience. 5-8 years of experience in clinical programming. End to End Clinical Programming experience in Rave OR Veeva. Study/DB Build, eCRF Build, Edit Checks programming, Migrations & PPC experience. Custom Functions programming experience if its Rave EDC; SAS is not required though. The ability to deal effectively with sponsors and internal customers at all levels. Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. Demonstrated experience in managing multiple priorities in a highly dynamic environment Experience working in a matrix-structured environment is preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. Ability to travel as necessary (up to 25%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY-Consulting - Data and Analytics – Manager - Data Integration Architect – Medidata Platform Integration EY's Consulting Services is a unique, industry-focused business unit that provides a broad range of integrated services that leverage deep industry experience with strong functional and technical capabilities and product knowledge. EY’s financial services practice provides integrated Consulting services to financial institutions and other capital markets participants, including commercial banks, retail banks, investment banks, broker-dealers & asset management firms, and insurance firms from leading Fortune 500 Companies. Within EY’s Consulting Practice, Data and Analytics team solves big, complex issues and capitalize on opportunities to deliver better working outcomes that help expand and safeguard the businesses, now and in the future. This way we help create a compelling business case for embedding the right analytical practice at the heart of client’s decision-making. The opportunity We’re looking for an experienced Data Integration Architect with 8+ years in clinical or life sciences domains to lead the integration of Medidata platforms into enterprise clinical trial systems. This role offers the chance to design scalable, compliant data integration solutions, collaborate across global R&D systems, and contribute to data-driven innovation in the healthcare and life sciences space. You will play a key role in aligning integration efforts with organizational architecture and compliance standards while engaging with stakeholders to ensure successful project delivery. Your Key Responsibilities Design and implement scalable integration solutions for large-scale clinical trial systems involving Medidata platforms. Ensure integration solutions comply with regulatory standards such as GxP and CSV. Establish and maintain seamless system-to-system data exchange using middleware platforms (e.g., Apache Kafka, Informatica) or direct API interactions. Collaborate with cross-functional business and IT teams to gather integration requirements and translate them into technical specifications. Align integration strategies with enterprise architecture and data governance frameworks. Provide support to program management through data analysis, integration status reporting, and risk assessment contributions. Interface with global stakeholders to ensure smooth integration delivery and resolve technical challenges. Mentor junior team members and contribute to knowledge sharing and internal learning initiatives. Participate in architectural reviews and provide recommendations for continuous improvement and innovation in integration approaches. Support business development efforts by contributing to solution proposals, proof of concepts (POCs), and client presentations. Skills And Attributes For Success Use a solution-driven approach to design and implement compliant integration strategies for clinical data platforms like Medidata. Strong communication, stakeholder engagement, and documentation skills, with experience presenting complex integration concepts clearly. Proven ability to manage system-to-system data flows using APIs or middleware, ensuring alignment with enterprise architecture and regulatory standards To qualify for the role, you must have Experience: Minimum 8 years in data integration or architecture roles, with a strong preference for experience in clinical research or life sciences domains. Education: Must be a graduate preferrable BE/B.Tech/BCA/Bsc IT Technical Skills: Hands-on expertise in one or more integration platforms such as Apache Kafka, Informatica, or similar middleware technologies; experience in implementing API-based integrations. Domain Knowledge: In-depth understanding of clinical trial data workflows, integration strategies, and regulatory frameworks including GxP and CSV compliance. Soft Skills: Strong analytical thinking, effective communication, and stakeholder management skills with the ability to collaborate across business and technical teams. Additional Attributes: Ability to work independently in a fast-paced environment, lead integration initiatives, and contribute to solution design and architecture discussions. Ideally, you’ll also have Hands-on experience with ETL tools and clinical data pipeline orchestration frameworks. Familiarity with broader clinical R&D platforms such as Oracle Clinical, RAVE, or other EDC systems. Prior experience leading small integration teams and working directly with cross-functional stakeholders in regulated environments What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What working at EY offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you About EY As a global leader in assurance, tax, transaction and Consulting services, we’re using the finance products, expertise and systems we’ve developed to build a better working world. That starts with a culture that believes in giving you the training, opportunities and creative freedom to make things better. Whenever you join, however long you stay, the exceptional EY experience lasts a lifetime. And with a commitment to hiring and developing the most passionate people, we’ll make our ambition to be the best employer by 2020 a reality. If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible. Join us in building a better working world. Apply now EY | Building a better working world EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.

At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY-Consulting - Data and Analytics – Manager - Data Integration Architect – Medidata Platform Integration EY's Consulting Services is a unique, industry-focused business unit that provides a broad range of integrated services that leverage deep industry experience with strong functional and technical capabilities and product knowledge. EY’s financial services practice provides integrated Consulting services to financial institutions and other capital markets participants, including commercial banks, retail banks, investment banks, broker-dealers & asset management firms, and insurance firms from leading Fortune 500 Companies. Within EY’s Consulting Practice, Data and Analytics team solves big, complex issues and capitalize on opportunities to deliver better working outcomes that help expand and safeguard the businesses, now and in the future. This way we help create a compelling business case for embedding the right analytical practice at the heart of client’s decision-making. The opportunity We’re looking for an experienced Data Integration Architect with 8+ years in clinical or life sciences domains to lead the integration of Medidata platforms into enterprise clinical trial systems. This role offers the chance to design scalable, compliant data integration solutions, collaborate across global R&D systems, and contribute to data-driven innovation in the healthcare and life sciences space. You will play a key role in aligning integration efforts with organizational architecture and compliance standards while engaging with stakeholders to ensure successful project delivery. Your Key Responsibilities Design and implement scalable integration solutions for large-scale clinical trial systems involving Medidata platforms. Ensure integration solutions comply with regulatory standards such as GxP and CSV. Establish and maintain seamless system-to-system data exchange using middleware platforms (e.g., Apache Kafka, Informatica) or direct API interactions. Collaborate with cross-functional business and IT teams to gather integration requirements and translate them into technical specifications. Align integration strategies with enterprise architecture and data governance frameworks. Provide support to program management through data analysis, integration status reporting, and risk assessment contributions. Interface with global stakeholders to ensure smooth integration delivery and resolve technical challenges. Mentor junior team members and contribute to knowledge sharing and internal learning initiatives. Participate in architectural reviews and provide recommendations for continuous improvement and innovation in integration approaches. Support business development efforts by contributing to solution proposals, proof of concepts (POCs), and client presentations. Skills And Attributes For Success Use a solution-driven approach to design and implement compliant integration strategies for clinical data platforms like Medidata. Strong communication, stakeholder engagement, and documentation skills, with experience presenting complex integration concepts clearly. Proven ability to manage system-to-system data flows using APIs or middleware, ensuring alignment with enterprise architecture and regulatory standards To qualify for the role, you must have Experience: Minimum 8 years in data integration or architecture roles, with a strong preference for experience in clinical research or life sciences domains. Education: Must be a graduate preferrable BE/B.Tech/BCA/Bsc IT Technical Skills: Hands-on expertise in one or more integration platforms such as Apache Kafka, Informatica, or similar middleware technologies; experience in implementing API-based integrations. Domain Knowledge: In-depth understanding of clinical trial data workflows, integration strategies, and regulatory frameworks including GxP and CSV compliance. Soft Skills: Strong analytical thinking, effective communication, and stakeholder management skills with the ability to collaborate across business and technical teams. Additional Attributes: Ability to work independently in a fast-paced environment, lead integration initiatives, and contribute to solution design and architecture discussions. Ideally, you’ll also have Hands-on experience with ETL tools and clinical data pipeline orchestration frameworks. Familiarity with broader clinical R&D platforms such as Oracle Clinical, RAVE, or other EDC systems. Prior experience leading small integration teams and working directly with cross-functional stakeholders in regulated environments What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What working at EY offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you About EY As a global leader in assurance, tax, transaction and Consulting services, we’re using the finance products, expertise and systems we’ve developed to build a better working world. That starts with a culture that believes in giving you the training, opportunities and creative freedom to make things better. Whenever you join, however long you stay, the exceptional EY experience lasts a lifetime. And with a commitment to hiring and developing the most passionate people, we’ll make our ambition to be the best employer by 2020 a reality. If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible. Join us in building a better working world. Apply now EY | Building a better working world EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.

At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY-Consulting - Data and Analytics – Manager - Data Integration Architect – Medidata Platform Integration EY's Consulting Services is a unique, industry-focused business unit that provides a broad range of integrated services that leverage deep industry experience with strong functional and technical capabilities and product knowledge. EY’s financial services practice provides integrated Consulting services to financial institutions and other capital markets participants, including commercial banks, retail banks, investment banks, broker-dealers & asset management firms, and insurance firms from leading Fortune 500 Companies. Within EY’s Consulting Practice, Data and Analytics team solves big, complex issues and capitalize on opportunities to deliver better working outcomes that help expand and safeguard the businesses, now and in the future. This way we help create a compelling business case for embedding the right analytical practice at the heart of client’s decision-making. The opportunity We’re looking for an experienced Data Integration Architect with 8+ years in clinical or life sciences domains to lead the integration of Medidata platforms into enterprise clinical trial systems. This role offers the chance to design scalable, compliant data integration solutions, collaborate across global R&D systems, and contribute to data-driven innovation in the healthcare and life sciences space. You will play a key role in aligning integration efforts with organizational architecture and compliance standards while engaging with stakeholders to ensure successful project delivery. Your Key Responsibilities Design and implement scalable integration solutions for large-scale clinical trial systems involving Medidata platforms. Ensure integration solutions comply with regulatory standards such as GxP and CSV. Establish and maintain seamless system-to-system data exchange using middleware platforms (e.g., Apache Kafka, Informatica) or direct API interactions. Collaborate with cross-functional business and IT teams to gather integration requirements and translate them into technical specifications. Align integration strategies with enterprise architecture and data governance frameworks. Provide support to program management through data analysis, integration status reporting, and risk assessment contributions. Interface with global stakeholders to ensure smooth integration delivery and resolve technical challenges. Mentor junior team members and contribute to knowledge sharing and internal learning initiatives. Participate in architectural reviews and provide recommendations for continuous improvement and innovation in integration approaches. Support business development efforts by contributing to solution proposals, proof of concepts (POCs), and client presentations. Skills And Attributes For Success Use a solution-driven approach to design and implement compliant integration strategies for clinical data platforms like Medidata. Strong communication, stakeholder engagement, and documentation skills, with experience presenting complex integration concepts clearly. Proven ability to manage system-to-system data flows using APIs or middleware, ensuring alignment with enterprise architecture and regulatory standards To qualify for the role, you must have Experience: Minimum 8 years in data integration or architecture roles, with a strong preference for experience in clinical research or life sciences domains. Education: Must be a graduate preferrable BE/B.Tech/BCA/Bsc IT Technical Skills: Hands-on expertise in one or more integration platforms such as Apache Kafka, Informatica, or similar middleware technologies; experience in implementing API-based integrations. Domain Knowledge: In-depth understanding of clinical trial data workflows, integration strategies, and regulatory frameworks including GxP and CSV compliance. Soft Skills: Strong analytical thinking, effective communication, and stakeholder management skills with the ability to collaborate across business and technical teams. Additional Attributes: Ability to work independently in a fast-paced environment, lead integration initiatives, and contribute to solution design and architecture discussions. Ideally, you’ll also have Hands-on experience with ETL tools and clinical data pipeline orchestration frameworks. Familiarity with broader clinical R&D platforms such as Oracle Clinical, RAVE, or other EDC systems. Prior experience leading small integration teams and working directly with cross-functional stakeholders in regulated environments What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What working at EY offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you About EY As a global leader in assurance, tax, transaction and Consulting services, we’re using the finance products, expertise and systems we’ve developed to build a better working world. That starts with a culture that believes in giving you the training, opportunities and creative freedom to make things better. Whenever you join, however long you stay, the exceptional EY experience lasts a lifetime. And with a commitment to hiring and developing the most passionate people, we’ll make our ambition to be the best employer by 2020 a reality. If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible. Join us in building a better working world. Apply now EY | Building a better working world EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.

Senior CDC - Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Data Coordinator to join our diverse and dynamic team. As a Clinical Data Coordinator at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies. What You Will Be Doing Create and maintain detailed data management plans and documentation, ensuring compliance with industry standards and regulatory requirements. Participate in the identification and resolution of data discrepancies and issues, working to streamline data flow and enhance data quality throughout the study lifecycle. Collaborate closely with cross-functional teams, including clinical operations and biostatistics, to develop and execute data management strategies tailored to specific studies. Perform other project activities as required in order to ensure that study timelines are met (for example, filing and archiving of study documentation , dispatching of queries to investigator sites for resolution, etc.). Mentor junior data coordinators, providing expert guidance on data reconciliation, coding, and cleaning procedures. Your profile Bachelor's degree in a relevant field, such as Life Sciences or Healthcare. Proven experience in clinical data management within the pharmaceutical or biotechNlogy industry. Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar). Strong attention to detail and the ability to work effectively in a fast-paced environment. Excellent communication skills and the ability to collaborate with cross-functional teams. KNwledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY-Consulting - Data and Analytics – Senior - Clinical Integration Developer EY's Consulting Services is a unique, industry-focused business unit that provides a broad range of integrated services that leverage deep industry experience with strong functional and technical capabilities and product knowledge. EY’s financial services practice provides integrated Consulting services to financial institutions and other capital markets participants, including commercial banks, retail banks, investment banks, broker-dealers & asset management firms, and insurance firms from leading Fortune 500 Companies. Within EY’s Consulting Practice, Data and Analytics team solves big, complex issues and capitalize on opportunities to deliver better working outcomes that help expand and safeguard the businesses, now and in the future. This way we help create a compelling business case for embedding the right analytical practice at the heart of client’s decision-making. The opportunity We’re looking for Clinical Trials Integration Developers with 5+ years of experience in software development within the life sciences domain to support the integration of Medidata’s clinical trial systems across the Client R&D environment. This role offers the chance to build robust, compliant integration solutions, contribute to the design of clinical data workflows, and ensure interoperability across critical clinical applications. You will collaborate closely with business and IT teams, playing a key role in enhancing data flow, supporting trial operations, and driving innovation in clinical research. Your Key Responsibilities Design and implement integration solutions to connect Medidata clinical trial systems with other applications within the clinical data landscape. Develop and configure system interfaces using programming languages (e.g., Java, Python, C#) or integration middleware tools (e.g., Informatica, AWS, Apache NiFi). Collaborate with clinical business stakeholders and IT teams to gather requirements, define technical specifications, and ensure interoperability. Create and maintain integration workflows and data mappings that align with clinical trial data standards (e.g., CDISC, SDTM, ADaM). Ensure all development and implementation activities comply with GxP regulations and are aligned with validation best practices. Participate in agile development processes, including sprint planning, code reviews, testing, and deployment. Troubleshoot and resolve integration-related issues, ensuring stable and accurate data flow across systems. Document integration designs, workflows, and technical procedures to support long-term maintainability. Contribute to team knowledge sharing and continuous improvement initiatives within the integration space. Skills And Attributes For Success Apply a hands-on, solution-driven approach to implement integration workflows using code or middleware tools within clinical data environments. Strong communication and problem-solving skills with the ability to collaborate effectively with both technical and clinical teams. Ability to understand and apply clinical data standards and validation requirements when developing system integrations. To qualify for the role, you must have Experience: Minimum 5 years in software development within the life sciences domain, preferably in clinical trial management systems. Education: Must be a graduate preferrable BE/B.Tech/BCA/Bsc IT Technical Skills: Proficiency in programming languages such as Java, Python, or C#, and experience with integration middleware like Informatica, AWS, or Apache NiFi; strong background in API-based system integration. Domain Knowledge: Solid understanding of clinical trial data standards (e.g., CDISC, SDTM, ADaM) and data management processes; experience with agile methodologies and GxP-compliant development environments. Soft Skills: Strong problem-solving abilities, clear communication, and the ability to work collaboratively with clinical and technical stakeholders. Additional Attributes: Capable of implementing integration workflows and mappings, with attention to detail and a focus on delivering compliant and scalable solutions. Ideally, you’ll also have Hands-on experience with ETL tools and clinical data pipeline orchestration frameworks relevant to clinical research. Hands-on experience with clinical R&D platforms such as Oracle Clinical, Medidata RAVE, or other EDC systems. Proven experience leading small integration teams and engaging with cross-functional stakeholders in regulated (GxP) environments. What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.

At Quanticate, we're pioneers in providing top-tier statistical and data management support to our clients. We're seeking a dedicated "Clinical Data Manager I" who's committed to upholding the highest standards, following procedures, and ensuring compliance with regulations, all while providing exceptional customer care. As a "Clinical Data Manager I" you will lead, co-ordinate, and action all tasks relating to Clinical Data Management from the start to the finish of a study & to project manage studies across CDM functions. Core Accountabilities: Activities required of a Clinical Data Manager I (however not restricted to) are as below: To contribute to the efficient running of the CDM department as part of the CDM leadership team. Ensure launch, delivery, and completion of all CDM procedures according to contractual agreement and relevant SOPs, guidelines, and regulations To pro-actively keep abreast of current clinical data management developments and systems To assist in the creation and review of in-house SOPs. To research and provide input into in-house strategies and systems. To perform medical coding activities on projects, if assigned. To perform other reasonable tasks as requested by management. Ensure consistency of process and quality across projects. Project management for allocated projects: To help plan and manage study timelines and resources. To manage progress against schedules and report to management. To perform project management across all functions for a study as appropriate. Management of CRFs and all related tasks Management of allocated staff: Allocation of projects in conjunction with Project Management, as appropriate Performance reviews, as required. Administer training and development of staff, as required. Key Relationships: Act as the primary CDM contact, both external and internal, for Quanticate projects. Manage work assignment and delivery of project tasks to the data processing and programming team as required Line management responsibilities for any assigned direct reports, including professional development/training and performance appraisals. Requirements Qualified to an appropriate standard, preferably to degree level in a life sciences subject Four to seven years of relevant experience in CRO Clinical Data Management domain. Extensive knowledge of at least 2 Clinical Data Management systems such as Oracle Clinical, Medidata Rave, Inform Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing CDM project leadership, strong communication skills Sound knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials Proven ability in client relationship management Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance. Benefits ◼ Competitive salary (Open to discussion based on experience ◼ Flexible working hours ◼ Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays) ◼ Medical Insurance for self and immediate family ◼ Gratuity ◼ Accidental Coverage ◼ Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)

About ProcDNA: ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 300+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey? What we are looking for We are seeking a Programmer Analyst with strong hands-on experience in EDC platforms such as Medidata RAVE, InForm, Central Designer, or Veeva Studio. The ideal candidate will have a solid understanding of clinical data standards, protocol interpretation, and the ability to build high-quality, compliant EDC databases. You will play a key role in supporting the end-to-end development of clinical databases and ensuring data integrity throughout the trial lifecycle. What you will do eCRF & EDC Development: Interpret clinical trial protocols to design eCRFs and build databases using Medidata RAVE, InForm, Central Designer, or Veeva Studio. Configure systems and implement edit checks, dynamic rules, and custom functions (C# for RAVE) based on DVS. Review & Validation: Conduct technical and functional reviews, support Sponsor Acceptance Testing (SAT), and ensure accuracy across all database components. Amendments & Issue Resolution: Manage protocol amendments, metadata updates, lead ICRM/SAM meetings, and resolve issues in QC, UAT, and production environments. Post-Go-Live & Coordination: Handle migrations, RFCs, and post-go-live activities. Generate sponsor reports (JReview, SAS, BOXI), act as DB Coordinator across trials, and mentor junior team members. Must Have EDC Expertise: 3 to 5 years of hands-on experience with at least one EDC platform — Medidata RAVE, InForm, Central Designer, or Veeva Studio (combination preferred). Strong skills in eCRF design, edit checks, dynamic rules, and custom functions (e.g., C# for RAVE). Clinical & Technical Knowledge: Solid understanding of clinical trial protocols, DVS interpretation, CDPS/SDV strategy, CRF annotation, and post-go-live activities, including migrations and RFCs. Quality & Communication: High attention to detail with strong adherence to ICH GCP and clinical data standards. Excellent written and verbal communication skills for effective team and sponsor collaboration. Educational Background: BE/B.Tech, M.Sc./MCA, or B.Sc./BCA in Computer Science or a related stream. Consistent academic performance with 60% or above in 10th, 12th, and graduation is mandatory.

About The Job About ProcDNA ProcDNA is a global consulting firm. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 275+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. At ProcDNA, innovation isn't just encouraged, it's ingrained in our DNA. What We Are Looking For Clinical Database Programmer with a solid understanding of Clinical Protocol, Medical and Scientific Principles of conducting clinical trials. We are seeking an individual who not only possesses the requisite expertise but also thrives in a fast-paced environment. What You’ll Do Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system and Setup Core Configurations. Implementing the Dynamic rules as per the Sponsor requirements. Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification. Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC. Incorporate internal feedback and update programs as required. Incorporate Sponsor Acceptance Testing (SAT) feedback. Maintain and update the eCRFs and their components as required for protocol amendments or required metadata updates. Perform second/final review for peer deliverables. Create RAVE System Configuration Specification (Core config, Report Config, e-learning config, Appendix config & coding spec in RAVE or other EDC). Incorporate RAVE Configuration Specification. Facilitate Internal Configuration Review Meeting (ICRM). Revise and update eCRF booklet, DVS and Configuration Specification. Facilitate Sponsor Acceptance Meeting (SAM). Handle issues related to QC/UAT/PROD and tracking issues to closer. Review of the DVS for clarity and to ensure checks are consistent and appropriate based on eCRF design. Provide feedback to DVS author. Support CRO trial activities, including CRF annotation, database setup, specification generation, Clinical view settings, and dataset comparison. Create reports as per the Sponsor specification document using JReview, SAS, BOXI. Estimate and perform migration process for Post Go-Live studies (handling RFCs). Performe DB Coordinator role for multiple trials. Mentor new hires in CRO and EDC activities. Must Have Protocol reading and understanding Expertise in ‘Critical Data Point Strategy (CDPS) or SDV’ implementation. Scientific background: A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials. Strong writing and communication skills: The ability to clearly articulate and concisely explain complex information. Research and analytical skills: Ability to gather, interpret, and synthesize data into insightful information. Attention to detail: Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etc. Project management skills: Managing the document development process and meeting timelines. People management skills: Managing the team of highly qualified individuals (applicable for Team Lead role only). Certified Medidata Study Builder (SDBE), Oracle - InForm/ Central Designer, Veeva Studio B.E./B.Tech - Computer Science-based courses or Circuit Branches) M.Sc./ MCA in the stream of Computer Science B.Sc./ BCA in the stream of Computer Science) Why Join Us? Be part of a fast-growing consulting firm making a real impact in the healthcare space. Work directly with leadership and stakeholders. Own and shape the marketing strategy, with full freedom to innovate and experiment. Locations we are currently hiring for this role: Pune, Gurgaon, Bangalore, Kochi, Hyderabad, Chennai Skills: database management,dynamic rules implementation,project management,central designer,plausibility and consistency checks,veeva studio,critical data point strategy (cdps),report generation (jreview, sas, boxi),attention to detail,data validation specification,edc systems,research and analytical skills,clinical protocol,ecrf layout design,rave studies,people management,clinical database programming,strong writing and communication,c# programming,medical and scientific principles,post go-live studies migration,oracle inform,protocol understanding

About The Job About ProcDNA ProcDNA is a global consulting firm. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 275+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. At ProcDNA, innovation isn't just encouraged, it's ingrained in our DNA. What We Are Looking For Clinical Database Programmer with a solid understanding of Clinical Protocol, Medical and Scientific Principles of conducting clinical trials. We are seeking an individual who not only possesses the requisite expertise but also thrives in a fast-paced environment. What You’ll Do Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system and Setup Core Configurations. Implementing the Dynamic rules as per the Sponsor requirements. Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification. Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC. Incorporate internal feedback and update programs as required. Incorporate Sponsor Acceptance Testing (SAT) feedback. Maintain and update the eCRFs and their components as required for protocol amendments or required metadata updates. Perform second/final review for peer deliverables. Create RAVE System Configuration Specification (Core config, Report Config, e-learning config, Appendix config & coding spec in RAVE or other EDC). Incorporate RAVE Configuration Specification. Facilitate Internal Configuration Review Meeting (ICRM). Revise and update eCRF booklet, DVS and Configuration Specification. Facilitate Sponsor Acceptance Meeting (SAM). Handle issues related to QC/UAT/PROD and tracking issues to closer. Review of the DVS for clarity and to ensure checks are consistent and appropriate based on eCRF design. Provide feedback to DVS author. Support CRO trial activities, including CRF annotation, database setup, specification generation, Clinical view settings, and dataset comparison. Create reports as per the Sponsor specification document using JReview, SAS, BOXI. Estimate and perform migration process for Post Go-Live studies (handling RFCs). Performe DB Coordinator role for multiple trials. Mentor new hires in CRO and EDC activities. Must Have Protocol reading and understanding Expertise in ‘Critical Data Point Strategy (CDPS) or SDV’ implementation. Scientific background: A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials. Strong writing and communication skills: The ability to clearly articulate and concisely explain complex information. Research and analytical skills: Ability to gather, interpret, and synthesize data into insightful information. Attention to detail: Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etc. Project management skills: Managing the document development process and meeting timelines. People management skills: Managing the team of highly qualified individuals (applicable for Team Lead role only). Certified Medidata Study Builder (SDBE), Oracle - InForm/ Central Designer, Veeva Studio B.E./B.Tech - Computer Science-based courses or Circuit Branches) M.Sc./ MCA in the stream of Computer Science B.Sc./ BCA in the stream of Computer Science) Why Join Us? Be part of a fast-growing consulting firm making a real impact in the healthcare space. Work directly with leadership and stakeholders. Own and shape the marketing strategy, with full freedom to innovate and experiment. Locations we are currently hiring for this role: Pune, Gurgaon, Bangalore, Kochi, Hyderabad, Chennai Skills: database management,dynamic rules implementation,project management,central designer,plausibility and consistency checks,veeva studio,critical data point strategy (cdps),report generation (jreview, sas, boxi),attention to detail,data validation specification,edc systems,research and analytical skills,clinical protocol,ecrf layout design,rave studies,people management,clinical database programming,strong writing and communication,c# programming,medical and scientific principles,post go-live studies migration,oracle inform,protocol understanding

About The Job About ProcDNA ProcDNA is a global consulting firm. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 275+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. At ProcDNA, innovation isn't just encouraged, it's ingrained in our DNA. What We Are Looking For Clinical Database Programmer with a solid understanding of Clinical Protocol, Medical and Scientific Principles of conducting clinical trials. We are seeking an individual who not only possesses the requisite expertise but also thrives in a fast-paced environment. What You’ll Do Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system and Setup Core Configurations. Implementing the Dynamic rules as per the Sponsor requirements. Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification. Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC. Incorporate internal feedback and update programs as required. Incorporate Sponsor Acceptance Testing (SAT) feedback. Maintain and update the eCRFs and their components as required for protocol amendments or required metadata updates. Perform second/final review for peer deliverables. Create RAVE System Configuration Specification (Core config, Report Config, e-learning config, Appendix config & coding spec in RAVE or other EDC). Incorporate RAVE Configuration Specification. Facilitate Internal Configuration Review Meeting (ICRM). Revise and update eCRF booklet, DVS and Configuration Specification. Facilitate Sponsor Acceptance Meeting (SAM). Handle issues related to QC/UAT/PROD and tracking issues to closer. Review of the DVS for clarity and to ensure checks are consistent and appropriate based on eCRF design. Provide feedback to DVS author. Support CRO trial activities, including CRF annotation, database setup, specification generation, Clinical view settings, and dataset comparison. Create reports as per the Sponsor specification document using JReview, SAS, BOXI. Estimate and perform migration process for Post Go-Live studies (handling RFCs). Performe DB Coordinator role for multiple trials. Mentor new hires in CRO and EDC activities. Must Have Protocol reading and understanding Expertise in ‘Critical Data Point Strategy (CDPS) or SDV’ implementation. Scientific background: A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials. Strong writing and communication skills: The ability to clearly articulate and concisely explain complex information. Research and analytical skills: Ability to gather, interpret, and synthesize data into insightful information. Attention to detail: Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etc. Project management skills: Managing the document development process and meeting timelines. People management skills: Managing the team of highly qualified individuals (applicable for Team Lead role only). Certified Medidata Study Builder (SDBE), Oracle - InForm/ Central Designer, Veeva Studio B.E./B.Tech - Computer Science-based courses or Circuit Branches) M.Sc./ MCA in the stream of Computer Science B.Sc./ BCA in the stream of Computer Science) Why Join Us? Be part of a fast-growing consulting firm making a real impact in the healthcare space. Work directly with leadership and stakeholders. Own and shape the marketing strategy, with full freedom to innovate and experiment. Locations we are currently hiring for this role: Pune, Gurgaon, Bangalore, Kochi, Hyderabad, Chennai Skills: database management,dynamic rules implementation,project management,central designer,plausibility and consistency checks,veeva studio,critical data point strategy (cdps),report generation (jreview, sas, boxi),attention to detail,data validation specification,edc systems,research and analytical skills,clinical protocol,ecrf layout design,rave studies,people management,clinical database programming,strong writing and communication,c# programming,medical and scientific principles,post go-live studies migration,oracle inform,protocol understanding

About The Job About ProcDNA ProcDNA is a global consulting firm. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 275+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. At ProcDNA, innovation isn't just encouraged, it's ingrained in our DNA. What We Are Looking For Clinical Database Programmer with a solid understanding of Clinical Protocol, Medical and Scientific Principles of conducting clinical trials. We are seeking an individual who not only possesses the requisite expertise but also thrives in a fast-paced environment. What You’ll Do Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system and Setup Core Configurations. Implementing the Dynamic rules as per the Sponsor requirements. Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification. Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC. Incorporate internal feedback and update programs as required. Incorporate Sponsor Acceptance Testing (SAT) feedback. Maintain and update the eCRFs and their components as required for protocol amendments or required metadata updates. Perform second/final review for peer deliverables. Create RAVE System Configuration Specification (Core config, Report Config, e-learning config, Appendix config & coding spec in RAVE or other EDC). Incorporate RAVE Configuration Specification. Facilitate Internal Configuration Review Meeting (ICRM). Revise and update eCRF booklet, DVS and Configuration Specification. Facilitate Sponsor Acceptance Meeting (SAM). Handle issues related to QC/UAT/PROD and tracking issues to closer. Review of the DVS for clarity and to ensure checks are consistent and appropriate based on eCRF design. Provide feedback to DVS author. Support CRO trial activities, including CRF annotation, database setup, specification generation, Clinical view settings, and dataset comparison. Create reports as per the Sponsor specification document using JReview, SAS, BOXI. Estimate and perform migration process for Post Go-Live studies (handling RFCs). Performe DB Coordinator role for multiple trials. Mentor new hires in CRO and EDC activities. Must Have Protocol reading and understanding Expertise in ‘Critical Data Point Strategy (CDPS) or SDV’ implementation. Scientific background: A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials. Strong writing and communication skills: The ability to clearly articulate and concisely explain complex information. Research and analytical skills: Ability to gather, interpret, and synthesize data into insightful information. Attention to detail: Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etc. Project management skills: Managing the document development process and meeting timelines. People management skills: Managing the team of highly qualified individuals (applicable for Team Lead role only). Certified Medidata Study Builder (SDBE), Oracle - InForm/ Central Designer, Veeva Studio B.E./B.Tech - Computer Science-based courses or Circuit Branches) M.Sc./ MCA in the stream of Computer Science B.Sc./ BCA in the stream of Computer Science) Why Join Us? Be part of a fast-growing consulting firm making a real impact in the healthcare space. Work directly with leadership and stakeholders. Own and shape the marketing strategy, with full freedom to innovate and experiment. Locations we are currently hiring for this role: Pune, Gurgaon, Bangalore, Kochi, Hyderabad, Chennai Skills: database management,dynamic rules implementation,project management,central designer,plausibility and consistency checks,veeva studio,critical data point strategy (cdps),report generation (jreview, sas, boxi),attention to detail,data validation specification,edc systems,research and analytical skills,clinical protocol,ecrf layout design,rave studies,people management,clinical database programming,strong writing and communication,c# programming,medical and scientific principles,post go-live studies migration,oracle inform,protocol understanding

About The Job About ProcDNA ProcDNA is a global consulting firm. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 275+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. At ProcDNA, innovation isn't just encouraged, it's ingrained in our DNA. What We Are Looking For Clinical Database Programmer with a solid understanding of Clinical Protocol, Medical and Scientific Principles of conducting clinical trials. We are seeking an individual who not only possesses the requisite expertise but also thrives in a fast-paced environment. What You’ll Do Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system and Setup Core Configurations. Implementing the Dynamic rules as per the Sponsor requirements. Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification. Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC. Incorporate internal feedback and update programs as required. Incorporate Sponsor Acceptance Testing (SAT) feedback. Maintain and update the eCRFs and their components as required for protocol amendments or required metadata updates. Perform second/final review for peer deliverables. Create RAVE System Configuration Specification (Core config, Report Config, e-learning config, Appendix config & coding spec in RAVE or other EDC). Incorporate RAVE Configuration Specification. Facilitate Internal Configuration Review Meeting (ICRM). Revise and update eCRF booklet, DVS and Configuration Specification. Facilitate Sponsor Acceptance Meeting (SAM). Handle issues related to QC/UAT/PROD and tracking issues to closer. Review of the DVS for clarity and to ensure checks are consistent and appropriate based on eCRF design. Provide feedback to DVS author. Support CRO trial activities, including CRF annotation, database setup, specification generation, Clinical view settings, and dataset comparison. Create reports as per the Sponsor specification document using JReview, SAS, BOXI. Estimate and perform migration process for Post Go-Live studies (handling RFCs). Performe DB Coordinator role for multiple trials. Mentor new hires in CRO and EDC activities. Must Have Protocol reading and understanding Expertise in ‘Critical Data Point Strategy (CDPS) or SDV’ implementation. Scientific background: A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials. Strong writing and communication skills: The ability to clearly articulate and concisely explain complex information. Research and analytical skills: Ability to gather, interpret, and synthesize data into insightful information. Attention to detail: Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etc. Project management skills: Managing the document development process and meeting timelines. People management skills: Managing the team of highly qualified individuals (applicable for Team Lead role only). Certified Medidata Study Builder (SDBE), Oracle - InForm/ Central Designer, Veeva Studio B.E./B.Tech - Computer Science-based courses or Circuit Branches) M.Sc./ MCA in the stream of Computer Science B.Sc./ BCA in the stream of Computer Science) Why Join Us? Be part of a fast-growing consulting firm making a real impact in the healthcare space. Work directly with leadership and stakeholders. Own and shape the marketing strategy, with full freedom to innovate and experiment. Locations we are currently hiring for this role: Pune, Gurgaon, Bangalore, Kochi, Hyderabad, Chennai Skills: database management,dynamic rules implementation,project management,central designer,plausibility and consistency checks,veeva studio,critical data point strategy (cdps),report generation (jreview, sas, boxi),attention to detail,data validation specification,edc systems,research and analytical skills,clinical protocol,ecrf layout design,rave studies,people management,clinical database programming,strong writing and communication,c# programming,medical and scientific principles,post go-live studies migration,oracle inform,protocol understanding

About the Role We are seeking a business-focused Enterprise Solutions Architect with deep experience across the pharmaceutical value chain — from early R&D and clinical development to commercial launch and real-world data integration. This role will work closely with Pharma and CRO clients to shape digital solutions, lead proposal development, and build transformative strategies using AI, data, and platform-centric innovations. What You Will Do Lead solutioning across the Pharma value chain , including: Pre-clinical and clinical trial digitization (e.g., eSource, EDC, DCT enablement) Clinical operations optimization and patient data flow management Lab digitization and automation with LIMS, ELN, CDS platforms CRO workflow modernization, including site engagement, eCOA, and data submission support Real-world data integration and analytics for post-approval studies and evidence generation Commercial analytics and omnichannel launch strategies Shape data-centric solutions across structured/unstructured clinical and real-world data with cloud-native architectures and AI enablement . Ideate AI/ML-enabled or NextGen solutions for: Trial optimization (site selection, patient matching, adherence prediction) Patient journey analytics and digital twin use cases in commercialization Brand performance forecasting and medical rep targeting Build differentiated proposals, solution POVs, and reusable digital assets for Pharma and CRO clients . Collaborate with delivery, product, and platform teams to co-develop ready-to-deploy solution frameworks and demos . Contribute to GTM initiatives by creating internal playbooks, sales kits, and co-innovation plans . What You Need Mandatory Qualifications: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Clinical Research, or Data/Engineering fields . 10+ years of experience in pharma technology services, clinical systems, or commercial pharma analytics . Deep understanding of end-to-end pharma processes , including clinical development, lab workflows, commercial ops, and data governance. Experience in solutioning around platforms like Medidata, Veeva Clinical Suite, Oracle Clinical, LabVantage, Spotfire, and Snowflake . Strong knowledge of CRO operating models , including site engagement, monitoring, and data services. Hands-on experience in developing solution architectures using cloud platforms (AWS, Azure) , AI/ML frameworks, and analytics platforms. Preferred Background: Previous experience in top IT engineering or ER&D organizations with Life Sciences clients. Proven track record in solutioning for digital trials, lab modernization, or post-launch data integration . Familiarity with DCT frameworks, ePRO/eCOA, and digital patient experience platforms . Strong collaboration, presentation, and executive communication skills . What Makes You Eligible Proven leadership in pharma digital transformation initiatives and enterprise solutioning. Strong ability to work cross-functionally with client teams, product leaders, architects, and delivery teams . Experience in building high-impact, AI/ML-driven pharma solutions across clinical, lab, and commercial functions. Demonstrated success in building solution POVs, GTM playbooks, and digital accelerators for Pharma and CRO clients.

Description Principal Clinical Programmer (Rave + Custom Functions) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Provides application administration and technical support as the subject matter expert on all core business packages, including but not limited to: Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, and supplemental packages such as migration mentoring/review, reporting tools, custom functions, etc. Utilizes primary development tools and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. Generates and maintains all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRF)s, database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports Monitors applications proactively for workflow alerts, system errors, performance issues and troubleshoot programming deliverable defects. Performs system integrations activities, application updates, and user acceptance testing. Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problemsolving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. Participates in and provides input at project review and departmental review meetings. Participates in bid defenses. Ensures high quality deliverables by providing senior review of ’program level’/multi-study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. Reviews and provides input on study budgets, manages project level metrics, progress, and status, for large programs of studies from key sponsors. Monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Assists with the creation of changeorders. Provides leadership, mentorship, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications and uses expanded technical skills to meet evolving project needs. Attends Quick Start Camps (QSCs) in the lead Clinical Programmer role for assigned studies. Provides leadership/oversight of five (5) to twenty (20) concurrent studies depending upon scope, similarity, program, and resourcing requirements. This may include the oversight of other lead programmers and their associated studies. Manages project resources, proactively alerting management of delivery and resourcing needs. Assists with management of application vendors and serves as an initial escalation contact. Monitors vendor service level agreements (SLAs) and reports metrics to upper management. Supervises the implementations of upgrades and new modules of remotely hosted vendors, acquiring all documentation and storing in the relevant areas. Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. Contributes towards the update of standard operating procedures and work instructions in line with department and company process and policy As required, oversees program level clinical programming operations by providing supervision for a team of clinical programmers. Responsibilities may include professional development performance appraisals, and employee advising for junior staff. Assigns project work and reviews workload for all direct reports. Manages staff development by establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level. Resolves conflicts/priorities at the program level prior to making any recommendations to management. Advises on administrative policies and procedures, technical problems, priorities, and methods. Qualifications Bachelor’s degree, Master’s degree preferred, In lieu of Bachelor’s degree, equivalent related education and experience. Must have experience with end-to-end clinical programming into Rave EDC. Strong Custom Functions programming experience. Must have programming lead experience. The ability to deal effectively with sponsors and internal customers at all levels. Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. Demonstrated experience in managing multiple priorities in a highly dynamic environment Experience working in a matrix-structured environment is preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. Ability to travel as necessary (up to 25%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Serves as lead Clinical Programmer to manage and support all functional tasks and projectdeliverables from single study assignments to large programs of studies. Manages multipleproject timelines and deliverable whilst leading less experienced programmers. Designs, writes,validates, and maintains software to meet specifications. Specifies, develops, and validatesapplications supporting data capture and processing. As senior technical subject matter expert,supports clinical programming and Data Management staff for Electronic Data Capture (EDC),reporting, and processing tools. Proactively monitors internally and externally hostedapplications for performance and/or system errors. Supports projects and applicationsexternally. Manages external application vendor issues, integrations, and implementations.May have supervisory responsibility and/or oversight for a team of lead clinical programmerswithin a program.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Responsibilities Responsibilities will include, but are not limited to Data Review Understand and review Protocol along with relevant study specific data review documents. Provide input to data review documents like Protocol Data Review Plan, Data Quality Management Plan Review clinical data listings and prioritize critical data review. Manage and facilitate resolution of data discrepancies. Perform data cleaning as per the defined Clean Patient Group. Freezing & Locking of CRFs/Fields. Coordinate with Data Management Lead for study deliverables. External Data Track data load and address discrepancies. Complete review of loaded external data and prioritize complex external data review e.g. Blinded Independent Committee Review, Biomarker, SAE Coordinate with external data vendor for resolution of data discrepancies as applicable. Documentation Filing of appropriate documents in eTMF as per eTMF master plan. Training and Mentorship Provide Training and mentoring to junior CDM staff. Bachelor's Degree required. Life sciences, Pharmacy or relevant fields preferred. 4 years of experience in Clinical Data Review tasks Able to work on clinical data review tasks Able to work collaboratively on multi-disciplinary project teams. Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills. Strong oral and written communication skills. Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Role : Clinical Systems Tester All candidates will be required to complete a SparkHire Assessment. We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies. Key Responsibilities: Author and execute test scripts in Veeva EDC , aligned with protocol requirements Validate workflows across eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms Participate in system validation (IQ/OQ/PQ, UAT) for DCT tools including handheld and remote-use devices Collaborate with clinical ops, data management, and vendors to troubleshoot issues and verify system behavior Review data capture logic and support query testing to ensure data accuracy Document test execution results, manage traceability, and support audit-readiness Contribute to ongoing improvements in test processes across DCT systems Required Experience: Strong, hands-on experience with Veeva CDMS (EDC) Working knowledge of eCOA platforms (e.g., Medidata, YPrime, Clinical Ink) Experience with IRT systems (e.g., Almac, 4G, Bioclinica) Prior involvement in DCT environments , including testing for remote or device-based workflows Understanding of clinical trial regulatory requirements (21 CFR Part 11, GxP) Detail-oriented with strong documentation and communication skills

Summary We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies. Key Responsibilities: • Author and execute test scripts in Veeva EDC, aligned with protocol requirements • Validate workflows across eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms • Participate in system validation (IQ/OQ/PQ, UAT) for DCT tools including handheld and remote-use devices • Collaborate with clinical ops, data management, and vendors to troubleshoot issues and verify system behavior • Review data capture logic and support query testing to ensure data accuracy • Document test execution results, manage traceability, and support audit-readiness • Contribute to ongoing improvements in test processes across DCT systems Required Experience: • Strong, hands-on experience with Veeva CDMS (EDC) • Working knowledge of eCOA platforms (e.g., Medidata, YPrime, Clinical Ink) • Experience with IRT systems (e.g., Almac, 4G, Bioclinica) • Prior involvement in DCT environments, including testing for remote or device-based workflows • Understanding of clinical trial regulatory requirements (21 CFR Part 11, GxP) • Detail-oriented with strong documentation and communication skills

Technical BA Exp: 10 - 15 years Looking for a Technical Business Analyst (BA) with strong domain knowledge in clinical trials and CTMS systems, who will work closely with the Data Engineering team to support clinical data integrations and migrations. You will play a critical role in bridging business needs with technical execution, especially as we scale our platform and onboard studies migrating from legacy or external systems into Medidata CTMS. This role requires a blend of clinical domain expertise, data awareness, and strong coordination skills to support data-driven product delivery. Key Responsibilities: Understand and document business and data requirements across clinical domains and translate them into actionable technical tasks Manage and maintain Jira boards for the Data Engineering team: groom stories, track progress, and coordinate with developers, QA, and stakeholders Act as a liaison between product, engineering, and external stakeholders to clarify requirements and ensure alignment across teams Drive the creation and maintenance of data entity mapping documentation between legacy systems and Medidata CTMS Collaborate with engineering leads to support ETL and data pipeline validation, including defining edge cases and expected behaviors Support UAT efforts for data integration/migration projects by coordinating validation cycles with clinical users and data stakeholders Identify risks, gaps, or inconsistencies in incoming data requirements and proactively resolve them Participate in data migration planning and execution experience with previous system-to-system migrations is a strong plus Required Qualifications: Minimum of 6 years of experience as a Business Analyst or Technical BA in the clinical trials or life sciences domain Strong understanding of clinical data and clinical workflows Experience with Jira, Confluence, and Agile/Scrum delivery models Familiarity with data models, data structures, and relational data concepts (SQL knowledge is a plus) Strong written and verbal communication skills with the ability to simplify complex topics for non-technical stakeholders Ability to manage multiple workstreams and keep deliverables on track Proven ability to create clear, structured documentation (e.g., data dictionaries, mappings, process flows) Preferred Qualifications: Experience with clinical data migrations (e.g., from Veeva, Oracle, or other CTMS systems to other systems) Understanding of ETL pipelines or working experience with data engineering teams Knowledge of CTMS, eTMF, EDC/Rave, or other clinical trial technologies Client stakeholder management, Team leading experience About Virtusa Teamwork, quality of life, professional and personal development: values that Virtusa is proud to embody. When you join us, you join a team of 27,000 people globally that cares about your growth — one that seeks to provide you with exciting projects, opportunities and work with state of the art technologies throughout your career with us. Great minds, great potential: it all comes together at Virtusa. We value collaboration and the team environment of our company, and seek to provide great minds with a dynamic place to nurture new ideas and foster excellence. Virtusa was founded on principles of equal opportunity for all, and so does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Company Name: Clinvigilant Research Pvt. Ltd. (A company of GSC Group) . Job Title: Clinical Data Manager Job Location: Ahmedabad- Onsite No. of Position :01 Experience : 03 to 06 Years. A Clinical Data Manager (CDM) plays a key role in managing and overseeing the data collected during clinical trials, ensuring its accuracy, integrity, and compliance with regulations. Here's a typical Job Description (JD) for a Clinical Data Manager Job Summary: The Clinical Data Manager oversees the collection, management, and quality control of clinical trial data. They will work closely with clinical research teams, statisticians, and regulatory authorities to ensure that data is accurately recorded, processed, and analyzed for clinical trials. The role involves ensuring that data is compliant with Good Clinical Practice (GCP) guidelines and relevant regulatory standards. Key Responsibilities: Data Management Plan (DMP): Develop, implement, and maintain the Data Management Plan for clinical trials. Ensure that the DMP aligns with study protocols, regulatory requirements, and internal standards. Database Design & Development: Collaborate with clinical and statistical teams to design and build electronic data capture (EDC) systems and clinical databases. Perform user acceptance testing (UAT) to ensure that the systems are functioning properly. Data Collection & Verification: Oversee the collection and validation of clinical trial data, ensuring all data is accurate and complete. Ensure data consistency by reviewing the case report forms (CRFs) for completeness, accuracy, and compliance. Data Cleaning & Quality Control: Implement and manage data cleaning processes, including discrepancy management, query resolution, and follow-up on data errors. Coordinate with clinical sites and vendors to resolve data issues and discrepancies promptly. Reporting & Documentation: Prepare and maintain comprehensive documentation related to data management processes and outcomes. Ensure all clinical trial data is properly archived for future reference and regulatory compliance. Regulatory Compliance: Ensure compliance with GCP, ICH guidelines, FDA regulations, and other applicable regulatory bodies. Support regulatory submissions by providing high-quality data sets and related documentation. Collaboration & Communication: Collaborate with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and IT departments. Serve as the primary point of contact for data-related queries and provide data insights to stakeholders. Training & Mentoring: Train clinical data staff and ensure they are informed of current processes, systems, and regulatory requirements. Provide ongoing guidance and mentorship to junior data management staff. Vendor Management: Manage and coordinate relationships with third-party vendors, including EDC providers, CROs, and other partners. Ensure that external vendors adhere to the agreed-upon timelines and data quality standards. Required Qualifications: Education: Bachelor’s degree in Life Sciences, Computer Science, Statistics, or related field. A Master's degree or professional certifications (such as CDISC, GCP, or Clinical Data Management certifications) are advantageous. Experience: 3-5 years of experience in clinical data management or related field, with a strong understanding of clinical trial processes and data handling. Skills: Proficiency with clinical data management systems (e.g., Medidata Rave, Oracle, or similar platforms). Strong understanding of clinical data management concepts, regulatory requirements, and industry standards. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills for effective cross-functional collaboration. Ability to work under pressure and meet tight deadlines. Preferred Qualifications: Experience working with complex clinical trials (multi-site, multi-region). Knowledge of regulatory submissions and reporting (e.g., FDA, EMA). Familiarity with statistical programming and data analysis tools (e.g., SASR). Job Types: Full-time, Permanent Pay: ₹30,000.00 - ₹50,000.00 per month Schedule: Monday to Friday Ability to commute/relocate: Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required) Application Question(s): how you rate yourself in english proficiency( beginner/ average/ professional)? Education: Bachelor's (Required) Experience: CDM: 3 years (Required) Location: Ahmedabad, Gujarat (Required) Expected Start Date: 03/01/2022

Exp: 10 - 15 years Looking for a Technical Business Analyst (BA) with strong domain knowledge in clinical trials and CTMS systems, who will work closely with the Data Engineering team to support clinical data integrations and migrations. You will play a critical role in bridging business needs with technical execution, especially as we scale our platform and onboard studies migrating from legacy or external systems into Medidata CTMS. This role requires a blend of clinical domain expertise, data awareness, and strong coordination skills to support data-driven product delivery. Key Responsibilities Understand and document business and data requirements across clinical domains and translate them into actionable technical tasks Manage and maintain Jira boards for the Data Engineering team: groom stories, track progress, and coordinate with developers, QA, and stakeholders Act as a liaison between product, engineering, and external stakeholders to clarify requirements and ensure alignment across teams Drive the creation and maintenance of data entity mapping documentation between legacy systems and Medidata CTMS Collaborate with engineering leads to support ETL and data pipeline validation, including defining edge cases and expected behaviors Support UAT efforts for data integration/migration projects by coordinating validation cycles with clinical users and data stakeholders Identify risks, gaps, or inconsistencies in incoming data requirements and proactively resolve them Participate in data migration planning and execution experience with previous system-to-system migrations is a strong plus Required Qualifications Minimum of 6 years of experience as a Business Analyst or Technical BA in the clinical trials or life sciences domain Strong understanding of clinical data and clinical workflows Experience with Jira, Confluence, and Agile/Scrum delivery models Familiarity with data models, data structures, and relational data concepts (SQL knowledge is a plus) Strong written and verbal communication skills with the ability to simplify complex topics for non-technical stakeholders Ability to manage multiple workstreams and keep deliverables on track Proven ability to create clear, structured documentation (e.g., data dictionaries, mappings, process flows) Preferred Qualifications Experience with clinical data migrations (e.g., from Veeva, Oracle, or other CTMS systems to other systems) Understanding of ETL pipelines or working experience with data engineering teams Knowledge of CTMS, eTMF, EDC/Rave, or other clinical trial technologies Client stakeholder management, Team leading experience

Senior Clinical Data Management Programmer Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Leads in the evaluation, implementation and validation of package systems to support Clinical Database review requests of all Clinical Database applications. Creates, maintains and oversees process for providing end user support for all Data review and ad hoc listings. Works very closely with Clinical Data Managers to develop study specifications listings and gain acceptance through user testing. Develops data quality listings to comply with related specifications and regulatory requirements. Processes database programming change requests. Documents all work fully according to FDA regulations and guidance, and company SOPs. Communicates programming and related document review statuses to management and the project teams. Primary Responsibilities Lead the development, validation, and maintenance of clinical reporting of clinical trials using a variety of validated software applications Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management documentation. Develop a variety of SAS/Data review/Visualization reports by integrating various sources of Data for efficient Clinical Data review and decision making Implement and test data quality checks in accordance with the study database specification listings. Manage and develop programs for the reconciliation of external data from vendors (e.g., central lab data) Serve as SME and facilitate integration of EDC systems to other clinical platforms such as CTMS, Reporting, and IRT as needed Assist in managing and providing listings to all medical coding dictionaries, including but not limited to MedDRA and WHODrug Oversee the management of Clinical report development, other GxP system user accounts and other help desk activities within Clinical reporting areas Develop EDC report listings, work with EDC vendors to resolve, and escalate issues appropriately to Senior Management. Work very closely with other functions to support ad hoc report development using tools such as Python, R Programming, Power BI, etc. Quickly learn new and/or advancements in software to become the SME for any technical question Demonstrate good problem-solving skills, a proactive approach, and a willingness to make decisions, seeking advice when necessary Facilitate and/or participate in writing departmental documentation (e.g., training documents, process guidance) Keep management team abreast of issues, progress, and risks related to trial operations Support bid defenses from a technical SME perspective Providing proactive ideas, support developing Insightful reports for supporting Data review process, Participate in other clinical programming and data management activities, as required Participate in internal and external team meetings, as required Mentor junior level clinical programmers Adhere to all aspects of the Statistics & Data Corporation’s quality system Comply with Statistics & Data Corporation’s data integrity & business ethics requirements Perform other related duties incidental to the work described herein Adherence to all essential systems and processes that are required at SDC to maintain compliance with business and regulatory requirements. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Requirements Required Skills Excellent understanding of relational database structures Fast, accurate programming skills using assorted application software SAS, R Programming, Python, PL/SQL, SQL, and XML programming skills Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships Demonstrated ability to provide both “user-friendly” and technical documentation Good time management and organization skills, including the ability to work in an efficient manner and prioritize tasks to meet tight deadlines while maintaining the highest standards of work Ability to provide expertise to guide department in continued efficiency and growth Knowledge of FDA regulations and guidance (e.g., 21 CFR Part 11, ICH/GCP) Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment Good knowledge of industry standard EDC tools (Medidata Rave, iMedNet, Viedoc, Veeva, etc.) Knowledge of Reporting application development (e.g., JReview, Business Objects, Python, PowerBI) is required Education or Equivalent Experience Bachelor’s degree in computer science or other quantitative or scientific discipline with 6+ years’ experience in database programming and demonstrated working knowledge of scientific principles. At least 6 years’ experience assuming lead report programming responsibilities on projects, with a minimum of 4 years in a clinical environment Experience with FDA regulations and guidance is required. Benefits Why SDC SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry. We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid

CDC II _ Office Based _ Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Data Coordinator II to join our diverse and dynamic team. As a Clinical Data Coordinator II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies. What You Will Be Doing Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures. Manage clinical and third-party data reconciliation based on edit specifications and data review plans. Tracks and communicates status of study and task metrics to clinical data scientist, project team, and functional management. Address data related questions and recommend potential solutions. Identify root cause to systematically resolve data issues. Your profile Bachelor's degree in a relevant field, such as Life Sciences or Healthcare. Intermediate kNwledge of clinical data management within the pharmaceutical or biotechNlogy industry. Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar). Strong attention to detail and the ability to work effectively in a fast-paced environment. Excellent communication skills and the ability to collaborate with cross-functional teams. KNwledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Senior Clinical Data Management Programmer Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Leads in the evaluation, implementation and validation of package systems to support Clinical Database review requests of all Clinical Database applications. Creates, maintains and oversees process for providing end user support for all Data review and ad hoc listings. Works very closely with Clinical Data Managers to develop study specifications listings and gain acceptance through user testing. Develops data quality listings to comply with related specifications and regulatory requirements. Processes database programming change requests. Documents all work fully according to FDA regulations and guidance, and company SOPs. Communicates programming and related document review statuses to management and the project teams. Primary Responsibilities Lead the development, validation, and maintenance of clinical reporting of clinical trials using a variety of validated software applications Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management documentation Develop a variety of SAS/Data review/Visualization reports by integrating various sources of Data for efficient Clinical Data review and decision making Implement and test data quality checks in accordance with the study database specification listings Manage and develop programs for the reconciliation of external data from vendors (e.g., central lab data) Serve as SME and facilitate integration of EDC systems to other clinical platforms such as CTMS, Reporting, and IRT as needed Assist in managing and providing listings to all medical coding dictionaries, including but not limited to MedDRA and WHODrug Oversee the management of Clinical report development, other GxP system user accounts and other help desk activities within Clinical reporting areas Develop EDC report listings, work with EDC vendors to resolve, and escalate issues appropriately to Senior Management Work very closely with other functions to support ad hoc report development using tools such as Python, R Programming, Power BI, etc Quickly learn new and/or advancements in software to become the SME for any technical question Demonstrate good problem-solving skills, a proactive approach, and a willingness to make decisions, seeking advice when necessary Facilitate and/or participate in writing departmental documentation (e.g., training documents, process guidance) Keep management team abreast of issues, progress, and risks related to trial operations Support bid defenses from a technical SME perspective Providing proactive ideas, support developing Insightful reports for supporting Data review process, Participate in other clinical programming and data management activities, as required Participate in internal and external team meetings, as required Mentor junior level clinical programmers Adhere to all aspects of the Statistics & Data Corporation's quality system Comply with Statistics & Data Corporation's data integrity & business ethics requirements Perform other related duties incidental to the work described herein Adherence to all essential systems and processes that are required at SDC to maintain compliance with business and regulatory requirements The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Requirements Required Skills Excellent understanding of relational database structures Fast, accurate programming skills using assorted application software SAS, R Programming, Python, PL/SQL, SQL, and XML programming skills Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships Demonstrated ability to provide both "user-friendly" and technical documentation Good time management and organization skills, including the ability to work in an efficient manner and prioritize tasks to meet tight deadlines while maintaining the highest standards of work Ability to provide expertise to guide department in continued efficiency and growth Knowledge of FDA regulations and guidance (e.g., 21 CFR Part 11, ICH/GCP) Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment Good knowledge of industry standard EDC tools (Medidata Rave, iMedNet, Viedoc, Veeva, etc.) Knowledge of Reporting application development (e.g., JReview, Business Objects, Python, PowerBI) is required Education Or Equivalent Experience Bachelor's degree in computer science or other quantitative or scientific discipline with 6+ years' experience in database programming and demonstrated working knowledge of scientific principles At least 6 years' experience assuming lead report programming responsibilities on projects, with a minimum of 4 years in a clinical environment Experience with FDA regulations and guidance is required Benefits Why SDC SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry. We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment We strive to provide a place of belonging to our employees with fun and engaging activities from SDC's culture club We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry With a proven track record, SDC has been successfully executing client clinical programs since 2005 Take a look at how you can join our team!

We are Growing ! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization. Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry. Your role: Act as a primary or backup Medical Monitor for the assigned clinical studies. Oversee multiple studies, contribute to the regulatory submissions (INDs, etc.) Responsible for providing protocol/therapeutic training to the study team, as required. Provide medical expertise to investigators and study team and advise on medical related questions. Perform eligibility review of the study subjects, as required. Lead in medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation. Escalate any critical safety concerns to the study team and Sponsor, and coordinate between sites and study team/Sponsor. Responsible for identifying, reviewing and confirming protocol deviation classification Lead the Medical Monitoring and Protocol deviation project meetings, participate in any other Sponsor calls, if required. Work closely with Safety and Pharmacovigilance team to provide medical input into safety reports including, SAE narratives and analysis of similar events, periodic safety reports. Responsible for the review of individual data with SAEs and potentially clinically important laboratory test results or vital sign abnormalities and escalate issues to the Sponsor as needed. Assist in medical and scientific review of deliverables such as TLFs and CSR. Lead in developing and maintaining SOPs, Templates, and study plans Participate in the review of the design and conduct of clinical trials including the development and review of protocols and amendments. Assist in incorporating medical strategy into study feasibility required for new projects. Cooperate with program development and commercial teams to develop the medical strategy for the RFP for new projects. Participate and lead medical strategy section in the Bid Defense preparation and meetings. Responsible for Line Management of assigned team members in Medical and Scientific Affairs group. Support regulatory inspections and audits as needed. Your Profile: Medical degree, MD or its international equivalent. Active medical license Fluent English (oral and written). Proven 5-7 years’ work experience within the life science industry or related field Minimum 4 years’ experience with medical monitoring services Strong understanding of GCP/ICH guidelines and applicable regulatory requirements Excellent verbal, written communication and presentation skills. Critical Thinking and background medical and scientific research Strong Proficiency in using Microsoft Office Experience with safety databases (ARISg, Oracle Argus, etc.) and/or EDC system (Zelta, Medrio, Oracle Clinical, Medidata) Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.