18 Edc Systems Jobs

As a Clinical Data Management (CDM) Executive at our company, your role will involve working closely with client study teams to design and configure user-friendly CRFs/eCRFs in EDC/CDM Systems. Your responsibilities will include preparing and reviewing validation logic, edit checks, and system rules to maintain data quality, as well as performing structured User Acceptance Testing (UAT) for databases and forms. You will also be expected to participate in functional and user acceptance testing of our in-house EDC system, validate edit checks and data integrity, and create and execute test cases to ensure compliance with system requirements and regulatory guidelines. Key Responsibilities: - Collaborate with client study teams to create user-friendly CRFs/eCRFs in EDC/CDM System. - Design and configure study databases in data management tools, including visit schedules, forms, fields, and relational structures. - Prepare/Review the validation logic, edit checks, and system rules to ensure data quality as per Protocol/DVP. - Perform structured User Acceptance Testing (UAT) for databases, forms, and edit checks and log, track, and retest issues until resolved. - Participate in functional and user acceptance testing of our in-house EDC system. - Validate edit checks, workflows, and data integrity in the EDC tool. - Create and execute test cases to verify compliance with system requirements and regulatory guidelines. Qualifications: - Bachelors/Masters degree in Life Sciences, Pharmacy, Physiotherapy, or related discipline. - Good written and verbal communication abilities. - Experience in clinical database design and data management using data management tools. - Understanding of CRF/eCRF design, DMP/DVP preparation, edit check specifications, and UAT processes. - Experience in query management and database lock activities. - Strong analytical, documentation, and problem-solving skills. **Note: No additional details about the company were provided in the job description.** Job Types: Full-time, Permanent Application Question(s): What is your current and expected CTC Experience: Clinical Data Management: 2 years (Preferred) Work Location: In person,

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) 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 Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must Have 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) Location Gurgaon / Pune Educational Qualifications 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

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) 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 Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must Have 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) Location Gurgaon / Pune Educational Qualifications 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

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) 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 Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must Have 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) Location Gurgaon / Pune Educational Qualifications 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

About the Role Role Description: The Manager will support the oversight of Rave EDC user access and management of Classic Rave and Rave EDC system upgrades for all Rave URLs. This role involves coordinating cross-functional activities to manage the Rave EDC Platform effectively. It requires a highly organized, proactive , and detail-oriented professional capable of managing multiple projects and meeting timelines. Roles & Responsibilities Technical Support / Project Coordination: Provide support for clinical trial platform technologies related to the Rave EDC System Work with the EDC vendor to translate business issues/requirements into technical solutions Manage Rave EDC FMT meetings , including agenda setting and meeting minutes Coordinate and oversee Rave User Access for all studies across all Rave URLs Evaluate potential use of other EDC systems , e.g., Veeva System Maintain standard business processes within GDO Systems to ensure regulatory compliance Coordinate with third-party vendors for Rave upgrades and custom script validation Collaborate with cross-functional teams for testing downstream systems affected by Classic Rave and Rave EDC releases Act as a liaison between R&D stakeholders and systems for Rave access and design of new functionality due to business or regulatory changes Serve as a technical point of contact with the DTI team to manage enhancements to systems (e.g., STAR, DMP) Provide technical and business process input for automation and new technology adoption Manage document creation and updates related to Rave User Access , including for acquisitions (e.g., Horizon) Conduct risk assessments for evaluation of alternative EDC systems (e.g., Veeva) Confidentiality & Professionalism: Handle sensitive and confidential information with discretion Act as a gatekeeper to ensure alignment with executive priorities Basic Qualifications and Experience Master's degree and 4 to 6 years of related experience Bachelor's degree and 6 to 8 years of related experience Diploma and 10 to 12 years of related experience Functional Skills Management and operational oversight of GDO systems, platforms, and tools (e.g., EDC) Ensure quality and timely operational delivery of system activities supporting EDC platform upgrades Lead or participate in the development, review, and implementation of processes, SOPs, and policies affecting GDO Drive continuous improvement in Rave User Access and EDC release validation processes Optimize Rave EDC release validation using AI and automated technologies Respond to R&D stakeholder inquiries related to Rave User Access and manage the EDC mailbox Must-Have Skills Strong technical and analytical skills with the ability to manage multiple projects Exceptional attention to detail and accuracy in deliverables Ability to work independently and proactively in a fast-paced environment Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) Familiarity with virtual collaboration tools (e.g., Teams, WebEx) Good-to-Have Skills Knowledge of pharmaceutical industry terminology Experience working in a multinational environment with global teams Familiarity with project management tools and methodologies Basic understanding of compliance and data privacy requirements Soft Skills Excellent verbal and written communication skills High degree of professionalism and interpersonal skills Strong problem-solving abilities and adaptability to changing priorities Resilience , discretion , and ability to thrive under pressure

As an Implementation Consultant reporting to the Product Owner, your key responsibilities will include creating User Requirement Specifications (URS) and functional requirement specs in Clinical Reporting and Analytics. You will be tasked with developing wireframes and mock-ups for clinical reports, as well as communicating with Clinical Data Management & Medical Reviewers to document clinical reporting needs. It is essential that you stay up-to-date with all Saama product features and releases. Your role will involve analyzing and understanding current business processes, events, and flows in Clinical Trial Development. You will act as a Clinical Subject Matter Expert, providing support for Clinical Project Support, authoring and documenting business requirements, and translating requirements into solutions. Additionally, you will create and maintain Data Mapping Specifications for the Saama Data Review Model. You will collaborate with customers, partners, and in-house teams to gather feedback and input on the product. As an Implementation Consultant, you will guide clients through release planning, manage communication with the team and stakeholders, lead product implementation efforts, and ensure the quality of project team deliverables. You will document and report project status and issues, identify and manage risks, and act as a client liaison to resolve outstanding issues promptly. Your responsibilities will also include ensuring a smooth transition of services from implementation to support, providing advanced analytical and reporting support to customers on various projects, and supporting configuration and quality checks with project teams. You will help identify and define new sources of relevant data, analyze data, and make recommendations. Desired skills for this role include experience in the Pharmaceutical industry, a good understanding of EDC, CTMS, IRT, and LAB Systems, proficiency in SQL, familiarity with CDASH, SDTM, and ADAM standards, and relevant degrees in Healthcare, Computer Science, or related fields. Additionally, experience as a Product Owner, familiarity with Agile Working Environment, SDLC phases, FDA regulations, and technical knowledge of Software Development and Web Development are preferred qualifications for this position.,

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include guiding the client through release planning, managing communication throughout the team and stakeholders, leading product implementation efforts, coordinating with customers, product SME, and other teams, managing the quality of implementation deliverables, and documenting and reporting status on Risks, Issues, Actions, and Decisions. You will need to identify, report, and manage risks while overcoming project obstacles. Acting as a client liaison and representative, you will communicate client feedback to appropriate representatives and act to resolve outstanding issues on behalf of the client in a timely manner. Understanding the client's clinical landscape, you will provide techno-functional solutions to evolving client needs. Your role will involve analyzing and understanding current business processes, events, and flows in Clinical Trial Development. You will create SOPs and Work instructions for the implementation/delivery team to ensure a smooth transition of services from implementation to support. Additionally, you should be able to incorporate feedback and input from customers, partners, and in-house teams on product features. Desired Skills: - Experience in the Lifesciences and Pharmaceutical industry is essential - Good experience in SQL, APIs, and Integrations - Good understanding of CDASH, SDTM, and ADAM standards - Good understanding of EDC Systems, CTMS Systems, IRT Systems, and LAB Systems - Knowledge of clinical trial domain, EDC study setup, and clinical reporting - Ability to build clinical reports and dashboards - Relevant degrees such as Bachelor's and Master's Degree in Healthcare, Computer Science, Technical, Engineering, Computer, Computer Engineering, Computer Programming - 3-5 years of experience as a Product Manager or 1-2 years of experience as a Product Owner - Comfortable and familiar with the Agile Working Environment - Experience working with all phases of SDLC - Familiarity with FDA regulations such as 21 CFR Part 11 and GxP is a bonus - Experience working in the complete product life cycle of two or more products - Technical knowledge including Software Development and Web Development - Experience with the use and configuration of healthcare software applications (preferably clinical),

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. We are seeking a dynamic Manager to join our Life Sciences Consulting team, specializing in Clinical Operations transformation. This role involves working with global pharmaceutical, biotech, and medtech clients to optimize R&D and clinical delivery models, streamline operations, and implement emerging technologies across clinical development. Experience: 7-10 years Education: M.Tech / M.Sc / Ph.D. in Life Sciences, Biotechnology, Pharmacology, Clinical Research, or related disciplines Preferred Background: Life Sciences Consulting | Clinical R&D | Clinical Operations Strategy Key Responsibilities: - Lead and manage client engagements focused on clinical operations transformation, process improvement, and technology enablement. - Design operating models, workflows, and KPIs for clinical development functions. - Collaborate with cross-functional teams (regulatory, safety, data management) to align clinical strategies with enterprise goals. - Prepare business cases, PoVs, and transformation roadmaps for clients. - Support proposal development and go-to-market (GTM) strategies in the clinical domain. - Mentor junior consultants and contribute to knowledge building within the practice. Must-Have Skills: - Strong understanding of the clinical development lifecycle (from trial design through close-out). - Demonstrated experience in managing/leading consulting engagements. - Exposure to CRO management, site selection, clinical monitoring, or clinical project management. - Excellent communication, stakeholder management, and analytical skills. Nice-to-Have Skills: - Familiarity with technologies like SDTM, CDISC, CTMS, eTMF, or EDC systems. - Prior experience with clinical digital transformation initiatives (e.g., decentralized trials, risk-based monitoring). - Certifications in clinical project management or data standards (e.g., CCDM). EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people, and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform, and operate. Working across assurance, consulting, law, strategy, tax, and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.,

You should have at least 2 years of experience in Clinical Trial EDC, preferably with systems like Veeva, RAVE, or Oracle, and/or Reporting experience, preferably with tools like JReview, Spotfire, Jupyter Labs, or SQL. You should be familiar with common troubleshooting tools and technologies such as JIRA, Dynamics, and have a good understanding of Microsoft Office products like Office, Excel, PowerPoint, and Dynamics. It would be ideal if you have an understanding of web technologies and web services like RESTful APIs, SOAP, and experience with database technologies such as Java, Python, and SQL, for troubleshooting issues related to cloud-based software systems. In addition to technical skills, you should possess excellent verbal and written communication skills to effectively explain technical concepts to both technical and non-technical audiences. Strong problem-solving skills are essential, along with a customer-centric mindset and a passion for helping clients resolve issues. You should be able to multitask, prioritize, and manage a high volume of requests efficiently. A Bachelor's degree in Computer Science, Information Technology, Life Sciences, or a related field would be preferred but not required.,

Are you ready to make a significant impact in the world of Biopharma Clinical Operations As an Associate Director in GCS Business Technology Solutions, you'll be at the forefront of driving industry-leading processes, technology, and services. Your role will be pivotal in owning the lifecycle management and continuous improvement of specific clinical operations processes, systems, or services. Collaborate with internal and external stakeholders to ensure customer needs are met and optimize the delivery of clinical studies. You'll identify and deliver improvements using tools like Lean Six Sigma to improve clinical study delivery. Are you up for the challenge Design, develop, implement, maintain, continuously improve, and provide ongoing customer support. Manage lifecycle of all system documents ensuring compliance with industry regulations and AstraZeneca policies. Communicate effectively and timely, providing high-quality training materials. Provide training, advice, and end-user support. Engage and influence key partners to drive strategy, development, and continuous improvement. Understand, evaluate, prioritize, and address customer requirements. Supervise performance by defining, tracking, and using key performance indicators for process improvements. Support audit and regulatory inspection planning, preparation, and conduct. Promote creative and innovative ideas to drive performance and deliver new solutions to customers. Essential Skills/Experience: - Bachelors of Science in an appropriate subject area or equivalent experience - Extensive knowledge of Drug Development within a pharmaceutical or clinical background - High level of business process, technology and Clinical Study information experience - Demonstrated project management skills to deliver to time, cost and quality - Ability to collaborate with, motivate and empower others to accomplish objectives - Experience working successfully with external partners delivering mutual benefit - Excellent written, verbal, influencing skills; negotiation, teamwork, problem solving, presentation skills - Experience in Medidata Rave including iMedidata user and site administration Desirable Skills/Experience: - Expert reputation within the business and industry - Experience using standard process improvement methodologies (e.g. Lean Six Sigma) - Experience in development and management of Business Processes for performance delivery - Comprehensive knowledge of ICH/GCP - Extensive experience in Validation of computerised systems in a regulated environment - Extensive experience of Quality Systems and Quality Management - Medidata Study Builder certification - Experience in other EDC systems (e.g Veeva, Bioclinica) - Experience in other Medidata products including Rave EDC When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, you'll find yourself in an environment that values transparency and expertise. Here, you can apply your skills across various functions to make decisions that prioritize patients. With a focus on continuous improvement and innovation, you'll be supported by leaders who empower you to work on initiatives that benefit both you and the business. Embrace global opportunities as you supply to research that makes a tangible difference worldwide. Ready to take on this exciting role Apply now and become part of our diverse team! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.,

As the EDC Systems Specialist, your primary responsibility will be to design eCRF layouts and databases in alignment with EDC systems. You will be tasked with setting up core configurations in Medidata Rave or other EDC platforms. It is mandatory for you to implement dynamic rules and custom functions using C# as per sponsor requirements. Additionally, you will create, test, and maintain edit checks based on Data Validation Specifications. Your role will involve incorporating internal feedback and SAT feedback from sponsors to enhance the eCRFs and components for protocol amendments and metadata updates. You will perform a second/final peer review of deliverables to ensure accuracy and compliance with the specified requirements. Developing RAVE System Configuration Specifications and conducting Internal Configuration Review Meetings (ICRM) and Sponsor Acceptance Meetings (SAM) will also be part of your responsibilities. You will be expected to handle issues related to QC/UAT/PROD environments and track them to closure efficiently. Supporting CRF annotation, dataset comparison, and Clinical View settings are essential tasks in this role. Furthermore, generating reports per sponsor specifications using JReview, SAS, BOXI, and performing database migration tasks for Post Go-Live studies are crucial aspects of this position. As a mentor, you will play a key role in guiding and supporting new hires, providing them with technical expertise and knowledge. Strong protocol reading and understanding skills are mandatory for this role. This is a full-time position that requires your presence in person at the designated work location.,

At EY, you will have the opportunity to shape your future with confidence, succeed in a globally connected powerhouse of diverse teams, and take your career wherever you desire. Join EY to help build a better working world. As a Data Integration Architect with 8+ years of experience in clinical or life sciences domains, you will lead the integration of Medidata platforms into enterprise clinical trial systems. Your role will involve designing scalable, compliant data integration solutions, collaborating across global R&D systems, and contributing to data-driven innovation in the healthcare and life sciences space. You will play a crucial part in aligning integration efforts with organizational architecture and compliance standards while engaging with stakeholders to ensure successful project delivery. Your key responsibilities will include designing and implementing scalable integration solutions for large-scale clinical trial systems involving Medidata platforms, ensuring compliance with regulatory standards such as GxP and CSV, establishing seamless system-to-system data exchange using middleware platforms or direct API interactions, collaborating with cross-functional teams to gather integration requirements, aligning integration strategies with enterprise architecture and data governance frameworks, supporting program management through data analysis and integration status reporting, interfacing with global stakeholders for smooth integration delivery, mentoring junior team members, participating in architectural reviews, and contributing to continuous improvement and innovation in integration approaches. To qualify for this role, you must have a minimum of 8 years of experience in data integration or architecture roles, preferably in clinical research or life sciences domains. You should hold a graduate degree in BE/B.Tech/BCA/Bsc IT and possess hands-on expertise in integration platforms like Apache Kafka, Informatica, or similar middleware technologies. Additionally, you should have in-depth understanding of clinical trial data workflows, integration strategies, and regulatory frameworks, along with strong analytical thinking, effective communication, and stakeholder management skills. Ideally, you will also have experience with ETL tools and clinical data pipeline orchestration frameworks, familiarity with clinical R&D platforms such as Oracle Clinical or RAVE, and prior experience leading small integration teams in regulated environments. At EY, you will have the opportunity to work with a team of professionals with commercial acumen, technical experience, and a passion for learning in a fast-moving environment. You will be part of a market-leading, multi-disciplinary team and have opportunities to work with EY Consulting practices globally across various industries. Working at EY offers you the chance to work on inspiring and meaningful projects, receive support, coaching, and feedback from engaging colleagues, develop new skills, progress your career, and enjoy freedom and flexibility in handling your role. EY is dedicated to building a better working world through its culture of training, opportunities, and creative freedom, ensuring a rewarding experience for all employees.,

As a Manager in GCS Business Technology Solutions at AstraZeneca, you will play a crucial role in leading and innovating in the realm of Biopharma Clinical Operations. Your primary responsibility will be to design, develop, and continuously improve processes, systems, and services that drive clinical study delivery. You will collaborate with internal and external stakeholders to meet customer needs and enhance the efficiency of clinical studies. Utilizing tools like Lean Six Sigma, you will identify and implement improvements to ensure optimal end-to-end delivery. Are you ready to make a difference in this dynamic and challenging role Your key accountabilities will include designing, developing, implementing, maintaining, and continuously improving systems while providing ongoing customer support. You will be responsible for lifecycle management of all system documents, ensuring compliance with industry regulations and AstraZeneca policies. Effective communication of information and provision of high-quality training materials will be essential aspects of your role. Additionally, you will provide training, advice, and end-user support, engage and influence key partners to drive strategy, development, and continuous improvement, and oversee EDC User Accesses and periodic reviews. Your role will also involve supporting audit and regulatory inspection planning, preparation, and conduct, delivering Corrective and Preventive Actions in a timely manner, and promoting creative and innovative ideas to drive performance and bring new solutions to customers. You will need to have a Bachelor of Science in an appropriate subject area or equivalent experience, extensive knowledge of Drug Development within a pharmaceutical or clinical background, and high-level business process, technology, and Clinical Study information experience. Moreover, you should possess demonstrated project management skills to deliver to time, cost, and quality, ability to collaborate with, motivate, and empower others to accomplish objectives, and experience working successfully with external partners delivering mutual benefit. Excellent written and verbal communication skills, negotiation, collaboration, problem-solving, presentation, mentoring, conflict management, and interpersonal skills are crucial for this role. Experience in Medidata Rave, including iMedidata user/site administration, report administration, core configuration, study build/edit check programming, is an essential requirement. Desirable skills and experience include having an expert reputation within the business and industry, experience applying standard process improvement methodologies like Lean Six Sigma, and comprehensive knowledge of ICH/GCP. Extensive experience in Validation of computerized systems in a regulated environment, Quality Systems, and Quality Management, as well as certifications in Medidata Study Builder and experience in other EDC systems like Veeva and Bioclinica, will be advantageous. Experience working within an agile environment using JIRA is also desirable. AstraZeneca values diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible. Join us in our mission to explore the possibilities of science, make a difference, and work towards treating some of the world's most complex diseases. If you are ready to make an impact and thrive in a collaborative and innovative environment, apply now to join our team! Date Posted: 04-Aug-2025 Closing Date: 24-Aug-2025,

The Clinical Data Manager is responsible for overseeing all data management activities pertaining to the conduct of Phase I-IV clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met. Participate as the primary data management representative on the QED multidisciplinary project teams and as the primary point of contact for all data management interactions with the Sponsor. Participate in protocol developments and review, in review of clinical study reports and statistical analysis plan, in the development of data dictionaries complete with variables, value specifications and coding standards, and in monitoring the quality of data management processes, data, and performance. Review and provide inputs to CRF design and CRF Completion Instructions, database design, data management/data validation plans, data entry guidelines, and revisions to the Standard Operating Procedures. Manage resource planning methodologies and project management to ensure study deliverables and timelines are met in collaboration with the Sponsor, the Sponsor change order process, and to ensure effective communication exchange between the multidisciplinary project teams. Assist/Work with Sr. Management in identifying, developing, and implementing processes to improve/enhance time and cost efficiencies, to provide current information and potential impact of changes on project deliverables and timelines, to identify trouble-shoot issues and provide proposed solutions for problem resolution, to evaluate future potential data management solutions (e.g. functional service provider models, EDC systems) and prepare a business plan, to individual development, training, knowledge, and expertise through research, technical bulletins, and attending appropriate seminars, and to endorse and convey QED's corporate mission statement. Qualifications/Experience: - Bachelor's/Master's degree in computer science, statistics, clinical research, biotechnology, from an appropriately accredited institution. - Minimum of 5 years of data management experience. - Project management experience is required. - Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required. - Direct management of employees within Clinical Data Management is preferred.,

You will be responsible for creating a catalogue of reports to support data cleaning activities with low to medium complexity. Your tasks will include automating manual checks, reconciliation, and program edit checks for TPV data to ensure quality. Additionally, you will develop tools and repositories to minimize data errors at the source for the collection of lab reference ranges. You will program reports to identify missing pages, detect errors at the Subject level, and create reports to measure metrics for assessing data cleaning status. Furthermore, you will be tasked with creating visualizations and dashboards to identify discrepancies and trends in EDC and TPV data. In addition to the above responsibilities, you will contribute to the implementation of cross-functional projects as part of the clinical programming roadmap. This will involve collaborating with various teams including data management, development operations, clinical, biometrics, and other relevant multi-functional teams supporting clinical trials to deliver end-user reporting needs. As a Clinical Programmer, your duties will encompass designing, developing, implementing, and validating programs created in SAS/Python/R/SQL or dashboard applications such as PowerBI/Spotfire/MicroStrategy to process, analyze, and report clinical trial data for review by clinical study teams. To be successful in this role, you should possess a Bachelor's degree or equivalent in computer science, life science, or statistics. You must have good programming skills and prior experience in SAS/Python/R/SQL, as well as familiarity with business intelligence technologies like Power BI and MicroStrategy. An understanding of data collection and industry data standards, EDC systems such as Medidata Rave/Inform/Veeva, and basic knowledge of the clinical development process are also required. Desirable skills include proficiency in Python/SAS/SQL programming, data visualization, and analytics using tools like MicroStrategy/PowerBI or other BI tools. Exposure to tools like Saama/SAS LSAF and knowledge of the Clinical Trial Life Cycle and Data Management domain would be advantageous. In summary, as a member of Virtusa, you will be part of a global team that values teamwork, quality of life, and professional development. You will have the opportunity to work on exciting projects, leverage state-of-the-art technologies, and collaborate with great minds in a dynamic environment that fosters excellence.,

As a Clinical Database Programmer at ProcDNA, you will play a crucial role in designing the eCRF layout and corresponding database, implementing dynamic rules based on Sponsor requirements, and creating trial-specific Edit Checks. Your responsibilities will also include developing Custom Functions using C# for Rave studies or other EDC systems, incorporating internal and Sponsor feedback, and maintaining eCRFs and components as per protocol amendments or metadata updates. Additionally, you will support CRO trial activities, create reports using JReview, SAS, BOXI, and handle migration processes for Post Go-Live studies. To excel in this role, you must have a deep understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials, and expertise in Critical Data Point Strategy (CDPS) or SDV implementation. Your strong writing, communication, research, and analytical skills will be essential in gathering, interpreting, and synthesizing data accurately. Attention to detail, project management capabilities, and the ability to manage a team are also crucial for success in this position. Ideally, you should be Certified in Medidata Study Builder (SDBE), Oracle - InForm/Central Designer, or Veeva Studio, with a background in Computer Science-based courses or Circuit Branches (B.E./B.Tech, M.Sc./MCA, B.Sc./BCA). Joining ProcDNA will offer you the opportunity to work in a fast-growing consulting firm that is making a real impact in the healthcare sector, collaborate directly with leadership, and contribute to shaping marketing strategies. Currently, we are seeking candidates for this role in Pune, Gurgaon, Bangalore, Kochi, Hyderabad, and Chennai. If you are passionate about database management, dynamic rules implementation, project management, and have a keen eye for detail, this role at ProcDNA could be the perfect fit for you. Apply now and be part of a team that values innovation, collaboration, and excellence in Commercial Analytics and Technology solutions.,

Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Study build and Edit check development Programming Languages Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline with 9+ years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CROs, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related discipline Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Manager, CSAR - Electronic Data Interchange and Acquisition Role Description The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical Reporting, focusing on Electronic Data Interchange/Acquisition programming activities. This role involves developing the Data Acquisition Requirements Specification (DARS) document to outline metadata transfer requirements, establish and validate vendor integration criteria, and manage the processing of electronic data from vendors. The position requires cross-functional collaboration to ensure high-quality deliverables, support clinical systems, and oversee electronic data capture technologies. The Manager, CSAR will be responsible for study-level and portfolio-level quality and deliverables while also contributing to large system transformation projects with project management, subject matter expertise, partner engagement, and change management responsibilities. A strong leadership mindset and ability to influence partners is essential, along with individual contribution to study-specific and general CSAR/Global Development Operations projects. Responsibilities Support clinical trial platform technologies and ensure smooth operations. Enable data-driven decision-making by providing analytical insights. Coordinate and provide programming support to Clinical Study Teams. Collaborate with Clinical Data Management to meet study deliverables and timelines. Act as a technical point of contact for systems deliverables on defined programs. Develop the DARS document, specifying metadata transfer requirements. Set up and test RWS integration requirements, supporting study closure with final data loads and transfer discontinuation. Configure data upload gateways between external vendors and Amgen. Provide technical and business process expertise on new and emerging technologies. Develop, review, and implement policies, SOPs, and associated documents. Assist in preparing for and responding to audit findings (internal or external). Basic Qualifications Bachelor's degree in Life Sciences, Computer Science, Business Administration, or related field with 9-13 years of experience. Proven experience in managing teams. Specialist knowledge/experience in Life Sciences or a medically related field. General biopharmaceutical clinical research experience (clinical trial experience at biotech, pharmaceutical, or CROs). Preferred Qualifications Advanced degree or equivalent in Life Science, Computer Science, Math, Statistics, Business Administration, or a related field with 9-13 years of experience. Broad knowledge/work experience in data management/programming in the pharmaceutical or biotech industry. Proven experience in managing teams. Project management and planning experience. Experience overseeing outside vendors (CROs, central labs, imaging vendors, IRT vendors, etc.). Must-Have Skills Good Clinical Practice. Expertise in performance management techniques, measures, problem-solving, and analytical thinking. Understanding of drug development and clinical trial processes. Data management processes. Clinical trial database programming and applications. Experience collecting, maintaining, and supporting data cleaning controls for external (non-EDC) data. Proficiency in importing clinical study data from central labs and imaging vendors. Knowledge of the systems development lifecycle. Programming languages expertise. Project planning and management. Ability to collaborate with global cross-functional teams (team/matrix environment). Quality management and risk analysis. Regulatory filings and inspections expertise. Process improvement methodologies. Soft Skills Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills.