652 Clinical Trials Jobs - Page 24

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Specialist Qualifications: BSc/Master of Pharmacy Years of Experience: 7 to 11 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom Years of Experience: 1 to 3 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BCom

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Analyst Qualifications: BCom Years of Experience: 3 to 5 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BCom

Dear Candidate , Join our growing team as a Sr. Medical Reviewer and be part of an international, fast-paced environment where your expertise makes a meaningful impact. Apply now and take the next step in your professional journey! Additional Input: Contact: LVYJ@novonordisk.com Apply Now : https://careers.novonordisk.com/job-invite/317647/ Location: Bangalore, India Position: Senior Medical Reviewer Key Requirements: Minimum 3+ years of experience as a Medical Reviewer MBBS & MD in Pharmacology preferred; MBBS & MD in other clinical or paraclinical specialties with relevant experience in clinical patient management or clinical research will also be considered. 12 years of project management experience is essential Solid understanding of ICH guidelines and GCP principles. If you're ready to contribute to meaningful global projects and grow with a forward-thinking team, apply now and be part of our journey

Project Role : Program/Project Management Lead Project Role Description : Manage overall delivery of a program or project to achieve business outcomes. Define project scope and monitor execution of deliverables. Communicate across multiple stakeholders to manage expectations, issues and outcomes. Must have skills : Pharmacovigilance & Drug Safety Surveillance Good to have skills : NA Minimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Program/Project Management Lead, you will oversee the delivery of programs or projects to achieve business objectives. You will define project scope, monitor execution, and communicate with stakeholders to manage expectations and outcomes effectively. Roles & Responsibilities: Involve monitoring and assessing the risks and benefits of medicines to patients, so it's vital for anyone working in this profession that the information they work on is accurate. Candidates will need to be thorough and precise in their work, paying attention to detail, as jobs in the pharmacovigilance sector require a responsible attitude. Incorrect information can have serious health and safety consequences. Expected to be an SME, collaborate and manage the team to perform. Responsible for team decisions. Engage with multiple teams and contribute on key decisions. Expected to provide solutions to problems that apply across multiple teams. Lead project planning and execution. Ensure project scope and objectives are clearly defined. Monitor project progress and address any issues. Communicate effectively with stakeholders to manage expectations. Professional & Technical Skills: -Observational skills as well as attention to detail-Analytical and problem-solving skills-Excellent communication skills, both written and verbalIT skills-Team working skills-Mathematical skills Project management and planning skills Ability to work in a fast-paced environment Additional Information: The candidate should have a minimum of 12 years of experience in Pharmacovigilance & Drug Safety Surveillance. This position is based at our Bengaluru office. A 15 years full time education is required. Qualifications 15 years full time education

The Principal Statistical Programmer ( Programmer ) will have experience in all required areas of a Senior Statistical Programmer. The Principal Statistical Programmer is responsible for providing statistical programming services for assigned clinical trials. This includes acting as the lead programmer for assigned clinical trials. Responsibilities Exceed expectations and responsibilities of a Senior Statistical Programmer Understand and implement CDISC and other regulatory standards Follow internal SAS programming conventions Serve as programming lead on complex clinical trials; or serve as portfolio lead across a large suite of studies for a sponsor Coordinate and ensure the accuracy and completeness of activities for assigned support programmers Create and maintain project timelines Design, develop, document and validate tools and macros to improve quality and efficiency of processes Prepare and review programming specifications for SDTM, ADaM and other derived datasets Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to: Analysis datasets (SDTM, ADaM, other derived datasets) Perform ad hoc analyses of current and legacy databases Review and provide input on case report form design Serve as a subject matter expert Train and mentor others in task execution Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs Develop department training materials and deliver trainings to the team Drive/facilitate/actively engage in department initiatives Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs Strong understanding of departmental and company procedures; ability to guide others on procedures Participate in the development and revision of department SOPs Support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc. Additional Responsibilities Assist in the preparation and review of monthly financial reporting Promote visibility outside of the functional area and effectively interact cross-functionally and in industry Perform other duties as requested by management Qualifications: The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree Minimum of 6 years direct SAS programming experience in pharmaceutical development or CRO environment Good knowledge of medical terminology and conduct and analysis of clinical trials Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.) Excellent oral and written communication skills, organizational skills, and attention to detail are required Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience. It is Advanced Clinical s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law. This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.

Under general direction, manage all laboratory aspects of assigned clinical trial projects for a Customer or a specific program for a Customer. May have responsibility for a specific Customer, drug program, indication or drug compound. Acts as the main point of contact for the Customer after study award and throughout the entire study lifecycle (startup, maintenance, closeout). Ensures work is conducted in line with standard operating procedures, policies and good practices. Essential Functions Study Setup and Planning: Facilitate seamless study set-up including Protocol and Budget review, leading meetings, develop and implement project plans, milestone, risk, issue and action logs. Partner with Study Setup team to ensure quality database set-up, oversee preparation of protocol specific documentation. Will prepare and present protocol-specific materials at Kick Off and Investigator meetings May participate in the proposal and business development process including bid defence meetings. Support development of Customer standards Study Activity Monitoring and Closeout: Will monitor the Project Management Plan, timelines and deliverables, manage study documentation throughout the Project lifecycle including filing into eTMF, oversee study monitoring and reporting, conduct meetings to meet needs of the Study and Customer requirements Will manage study scope changes and budget monitor quality of the study and any service-related issues, implementing changes as required. Lessons learnt will be reviewed and shared Proactive Lines of Communication: Build and own the Customer relationship, facilitate communication, collaborate with all operational areas within the company Will serve as an escalation point for study level issues and will coordinate and triage study-specific issues Coordinates customer survey follow up and ongoing health checks to support Customer relationship building Meetings, Initiatives and Training Activities: Will represent the company at Investigator meetings and other internal / external face to face meetings. Will participate in audits and inspections as required Will provide study training to sites, CRAs and customers Will establish regular lines of communication with sites to manage on-going project expectations and issues. Will participate in improvement projects as needed Will assist in training of less experienced staff. Qualifications Bachelors Degree Life Sciences and/or related field Pref Or Other Equivalent combination of education, training and experience may be accepted in lieu of degree. 2+ years of clinical or research industry experience, including 1 year project management / project set up experience Pref Or Equivalent combination of education, training and experience Strong interpersonal and customer management skills. Working understanding of medical and clinical research terminology. Working knowledge of Project Management processes, the company laboratory processes, and/or equivalent working knowledge of central laboratory operations (kits/supplies, logistics, laboratory operations, specimen storage, data reporting and transfers, site alerts, etc.) preferred. Demonstrated computer proficiency with Microsoft Office and the company systems, or equivalent experience with similar Centralized Laboratory systems preferred. Experience in successfully leading Phase I-IV clinical trials preferred. Demonstrated ability to work in a fast-paced environment while possessing strong organizational skills and a demonstrated ability to meet deadlines. Strong written and verbal communication skills including good command of English language. In certain geographies where communication in local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred. Ability to establish and maintain effective working relationships with coworkers, managers and customers.

Job Description Jira Administrator About ArisGlobal (www.arisglobal.com): ArisGlobal is empowering life science organizations to deliver breakthroughs faster , accurately , and with precision. This is paramount for the passage of lifesaving medications and products VIA clinical trials, using our software and technology. As an industry leader, ArisGlobal provides our SaaS leading technology and services to 40/50 top Bio-pharmaceutical corporations, 4/5 of the most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada and the NMPA, for example, around the world. 2021 has presented simultaneous developments in the global Drug Safety and Pharmacovigilance Software Market, projecting unfaltering growth through 2027. Effectively harnessed by prominent market drivers, ArisGlobal is named a Key Player. Located in Miami, New Jersey, Budapest, Dublin, Darmstadt, Rome, Tokyo, Shanghai, Bangalore, Mysore, our global presence is clear, and we are growing faster than ever . Position Overview The Jira Admin will be responsible for the effective use and administration of Jira software across the organization. The role requires a deep understanding of Jiras functionality, configuration, and integration capabilities. The ideal candidate will be able to apply knowledge of different project management processes, design JIRA workflows with an agile mindset and support the implementation of JIRA and other applications within the Atlassian Marketplace. Required Skills and Experience Minimum of 3-5 years of experience working with Jira in a technical or administrative capacity. Proven experience configuring and administering Jira (Software, Service Management, Confluence, etc.). Strong understanding of Jira workflows, permissions, and automation rules. Experience integrating Jira with other tools (e.g., GitHub, Bitbucket, Slack). Ability to work effectively remotely in cross-functional teams. Ability to meet deadlines and produce quality work. Responsibilities Manage and configure Jira instances, including project creation, workflows, permissions, and user management. Administer Jira Software, Jira Service Management, and other Jira tools (e.g., Confluence, Bitbucket) for all teams within the organization. Customize Jira to support specific needs, including dashboards, reports, workflows, and custom fields. Work closely with stakeholders to understand project requirements and design solutions that optimize the use of Jira for project tracking and reporting. Conduct regular Jira audits and provide recommendations for performance improvements and efficient configurations. Ensure that workflows and automation rules are designed to meet the needs of the business and increase productivity. Act as the primary point of contact for Jira-related issues, providing troubleshooting support and ensuring the platform runs smoothly for users. Provide guidance and assistance on customizations, integrations, and issue resolution to team members. Develop training materials, documentation, and user guides to help employees effectively use Jira. Conduct regular training sessions, workshops, and onboarding for new users to ensure proficiency with Jira tools. Stay updated on Jira best practices and industry trends, ensuring the team is always using the latest features. Partner with cross-functional teams to ensure Jira aligns with business requirements and evolving needs. Provide ongoing consultation on Jira usage, suggesting improvements to maximize efficiency. Collaborate with IT teams to ensure Jira integrates seamlessly with other tools and systems used by the organization.

Project Assistant Imaging _ Office Based _ Chennai/Trivandrum We are currently seeking a Project Assistant, Imaging to join our diverse and dynamic team. As a Project Assistant in Imaging at ICON, you will provide crucial support to the imaging project teams by coordinating administrative tasks, ensuring smooth project operations, and facilitating communication between departments. Your role will be essential in maintaining project documentation, tracking progress, and supporting the execution of imaging-related clinical trials. What You Will Be Doing: Assisting imaging project managers and teams with scheduling meetings, preparing agendas, and documenting meeting minutes to support efficient project execution. Managing and maintaining imaging project documentation, ensuring accuracy and timely updates in accordance with project requirements. Coordinating the flow of information between imaging teams and cross-functional departments, ensuring clear and effective communication. Tracking project timelines, milestones, and deliverables, providing support to ensure projects stay on schedule. Supporting the preparation of imaging reports, presentations, and other project-related materials as required. Your Profile: Bachelor s degree in business, life sciences, or a related field is preferred, though relevant experience in project support or administration within clinical trials or imaging is acceptable. Strong organizational and time management skills, with the ability to handle multiple tasks and prioritize effectively. Excellent communication and interpersonal skills, with a collaborative approach to working across departments and teams. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and experience with project management tools is a plus. Detail-oriented, proactive, and adaptable, with a commitment to supporting the successful completion of imaging projects. 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 Allstate, great things happen when our people work together to protect families and their belongings from lifes uncertainties. And for more than 90 years our innovative drive has kept us a step ahead of our customers evolving needs. From advocating for seat belts, air bags and graduated driving laws, to being an industry leader in pricing sophistication, telematics, and, more recently, device and identity protection. About The Role The Application Developer Lead Consultant provides code/design analysis and strategy, supports project planning, and develops code and designs for complex projects. They manage the review of code, design, and testing for lower band Application Developers and peers. They serve as a technical expert, coach and mentor for other application developer specialists and professionals. The Lead Consultant works closely with business partners to identify needs and design technology solutions toovercome process bottlenecks, reduce use of contingent claim resources, reduce compliance risks, or generally increase operational efficiency. They are often required to deliver tactical solutions that can be implemented within a few days. They are responsible for all phases of the application development cyclebeginning with requirements gathering, through release, and ultimately ongoing user support. Key Responsibilities Should have strong JAVA, spring boot, triage, TDD and test understanding. "¢ Assists with detailed project estimating and milestone planning. Reviews and validate accuracy of others estimates and works with project managers in continuous process improvement for estimating "¢ Develops code for complex to highly complex modules with high-level architecture, following documentation and development standards "¢ Ensures that design/code reviews are scheduled and executed; provide feedback and recommends solutions; ensures that design standards and documentation are followed and certifies that code meets quality standards; reviews and critiques code presented by team members. "¢ Critiques and evaluates detailed business, functional, and high-level technical requirements (including recovery, security and audit) "¢ Performs root cause analysis to prevent recurrence of problem and manages the resolution of complex problems "¢ Defines and manages process by which support and technical assistance is performed "¢ Leads and organizes testing reviews. Tracks and resolves complex defects and assists in planning efforts of complex functional tests in support of Quality Control (QC) "¢ Ensures project change management approach is followed and that enhancements are appropriately prioritized and developed, and delivered to Developers, Quality Control Analysts, and Environment Management personnel, and that all documentation is completed appropriately. "¢ Contributes to determining programming approach, tools, and techniques that best meet the business requirements. Promotes and defines development standards and high architectural standards. Education "¢ 4 year Bachelors Degree (Preferred) Experience "¢ 5 or more years of experience (Preferred) Supervisory Responsibilities "¢ This job does not have supervisory duties. Education & Experience (in lieu) "¢ In lieu of the above education requirements, an equivalent combination of education and experience may be considered. Primary Skills Application Development, Code Reviews, Process Improvements, Technical Consulting, Technical Requirements Shift Time Shift B (India) Recruiter Info Shriya Kumari skuow@allstate.com About Allstate Joining our team isnt just a job "” its an opportunity. One that takes your skills and pushes them to the next level. One that encourages you to challenge the status quo. And one where you can impact the future for the greater good. Youll do all this in a flexible environment that embraces connection and belonging. And with the recognition of several inclusivity and diversity awards, weve proven that Allstate empowers everyone to lead, drive change and give back where they work and live. Good Hands. Greater Together. The Allstate Corporation is one of the largest publicly held insurance providers in the United States. Ranked No. 84 in the 2023 Fortune 500 list of the largest United States corporations by total revenue, The Allstate Corporation owns and operates 18 companies in the United States, Canada, Northern Ireland, and India. Allstate India Private Limited, also known as Allstate India, is a subsidiary of The Allstate Corporation. The India talent center was set up in 2012 and operates under the corporations Good Hands promise. As it innovates operations and technology, Allstate India has evolved beyond its technology functions to be the critical strategic business services arm of the corporation. With offices in Bengaluru and Pune, the company offers expertise to the parent organizations business areas including technology and innovation, accounting and imaging services, policy administration, transformation solution design and support services, transformation of property liability service design, global operations and integration, and training and transition. Learn more about Allstate India here.

Image Data Processing Technologist _ Office Based _ Chennai/Trivandrum 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 an Image Data Processing Technologist to join our diverse and dynamic team. You will collaborate with cross-functional teams to enhance the efficiency and effectiveness of imaging data in clinical research. What you will be doing Maintain a positive, results-oriented work environment by building partnerships, modeling teamwork as well as communicating in an open, balanced, and objective manner Verifying incoming documentation and data for GCP/HIPAA violations and responding according to outlined procedures in a timely manner to rectify them Preparing / loading / demographically reviewing data for analysis Managing and filing documentation associated with projects Identifying issues with received data and notify project specific sites, customers and internal staff following internal processes to open, monitor, and resolve queries May represent Incoming Data Processing in internal meetings Compliance with internal SOPs Your Profile: Bachelor s degree in radiologic technology, medical imaging, or a related field; relevant certifications preferred. 1 - 4 years of experience in medical imaging or related roles, preferably within a clinical research environment. Strong knowledge of imaging techniques and technologies, as well as regulatory guidelines governing imaging in clinical trials. Excellent organizational and problem-solving skills, with a keen attention to detail. Effective communication and interpersonal skills, with the ability to work collaboratively with diverse teams. 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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 requirementsWe 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 EmployeePlease click here to apply

Image Data Processing Technologist _ Office Based _ Chennai/Trivandrum . We are currently seeking an Image Data Processing Technologist to join our diverse and dynamic team. You will collaborate with cross-functional teams to enhance the efficiency and effectiveness of imaging data in clinical research. What you will be doing Maintain a positive, results-oriented work environment by building partnerships, modeling teamwork as well as communicating in an open, balanced, and objective manner Verifying incoming documentation and data for GCP/HIPAA violations and responding according to outlined procedures in a timely manner to rectify them Preparing / loading / demographically reviewing data for analysis Managing and filing documentation associated with projects Identifying issues with received data and notify project specific sites, customers and internal staff following internal processes to open, monitor, and resolve queries May represent Incoming Data Processing in internal meetings Compliance with internal SOPs Your Profile: Bachelor s degree in radiologic technology, medical imaging, or a related field; relevant certifications preferred. 1 - 4 years of experience in medical imaging or related roles, preferably within a clinical research environment. Strong knowledge of imaging techniques and technologies, as well as regulatory guidelines governing imaging in clinical trials. Excellent organizational and problem-solving skills, with a keen attention to detail. Effective communication and interpersonal skills, with the ability to work collaboratively with diverse teams. 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 requirementsWe 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 EmployeePlease click here to apply

Key Responsibilities Technical Leadership - Lead and manage the Clinical Trial Transparency team to ensure timely, consistent, and accurate delivery of anonymised documents including full protocols, reporting and analysis plans and clinical study reports to external registers e.g., ClinicalTrials.gov, EU Clinical Trials Register and GSK/ViiV Study Register, and to other national registers, as required. Accountable for: (1) establishing priorities for document anonymisation and ensuring proper controls are in place and (2) operational delivery across the therapy areas by ensuring transparency deliverables meet the requirements of Health Authorities/Regulatory Agencies, Industry Associations, and GSK policy transparency commitments, all of which evolve regularly and maintain robust performance as defined by key performance indicators. Additionally, provide strategic direction and leadership in regulated and policy driven clinical transparency to a team of recognized subject matter experts and manage external resources (outsourced, platforms, consultants) to ensure availability of adequate resources in line with workload needs. Digital Innovation - Lead the thinking and implementation of digital content generation systems using AI/ML within CTT to enhance efficiencies associated with development of disclosure summaries, while ensuring compliance to regulation and quality are met. Support the development of digital dashboards (e.g. Power BI) for measuring CTT KPIs and for tracking CTT deliverables. Build strategies for mini automation projects to carry out routine tasks that will result in improved throughput and better resource utilization. Scientific Business Expertise - Provide strategic direction and leadership in regulated and policy driven clinical disclosures to a team of recognized subject matter experts and management of external resources (outsourced, platforms, consultants) to ensure adequate resources to address workload needs. Cross-functional Stakeholder Management - Partner with and lead interactions with senior management in relevant functional areas. Establish strong relationships with internal business partners (Clinical Sciences, Development Operations, Biostatistics, and Regulatory. etc.) and be the primary contact for all regulated and policy disclosures supporting the entire GSK R&D portfolio. Drive key change management initiatives with these teams to enhance ways of working in line with key organizational goals. Identify ways to continuously create awareness on transparency requirements to stakeholders through the appropriate use of digital communication tools (e.g. informercial videos, bulletins, roadshows, etc.). Process Excellence - Drive the processes for transparency activities leading to timely, accurate and high-quality information posted to public websites. Establish and integrate consistent processes for trial transparency activities throughout the portfolio. Maintain oversight for processes improvement/ efficiencies for the transparency function according to evolving requirements. Bring specialized knowledge of global transparency requirements and standards and provide guidance on best practices to ensure quality of information shared publicly and ensure compliance with defined requirements. Work closely with other roles in CTT (e.g. business capability lead) to strengthen the process knowledge of team members and ensure that written standards and document templates are consistent with changes in regulation/policy or current ways of working, synchronized with global changes in transparency requirements and bring in best practices and standards for transparency. Empower other roles within CTT to function as key enablers of clinical trial conduct by ensuring that regulatory/policy commitments for transparency are met ahead of planned timelines, to support critical organizational initiatives. Industry Benchmarking - Monitor, communicate and proactively plan in response to changes in global Clinical Trial Transparency Regulations including new industry trends and translate into GSK s Clinical Trial Transparency strategy. Maintain GSK initiatives of building trust at the highest standards by continuous adaptation of the internal process to be aligned with the external evolving requirements. Collaborate with other roles in CTT (e.g. benchmarking lead) to identify processes to continually scan the external environment for latest industry trends in transparency. Based on this information, develop processes for authoring of smart disclosure documents that will enable GSK to maintain its industry leading position in transparency, while ensuring that GSK also retains its competitive advantage. Work closely with responsible roles for effective management of Company/Critical Confidential Information in public disclosure documents. Transparency Knowledge Management - Provide medical governance advice in the field of anonymisation on a regular basis to stakeholders across therapy area. Assist trial teams with the collection of required information for postings, answer their questions regarding posting requirements and processes, including recommending resolution or workaround to complex issues, with appropriate consideration of possible impacts. Enterprise Risk Management - Ensure implementation of the risk management framework, including risk identification, assessment and prioritization and the definition of mitigation plans. Design and develop risk mitigation strategies while proactively identifying business transparency risks and implementing strategies to manage the impact of these risks on the business. Business Performance Monitoring - Establish and track key performance indicators that demonstrate compliance with applicable transparency regulations and internal policy. Monitor KPIs for continuous improvement in clinical transparency (e.g. through Transparency Dashboard), including KPIs for oversight of vendors performing the services. Systems and Tools - Integrate disclosure systems with other enterprise systems seamlessly to ensure that information flow is accurate, timely and purposeful. Work closely with disclosure system owners to implement enhancements, improvements and leverage the full functionality of such systems. Lead discussions with owners/stakeholders of complementary business systems to set up efficient networking with the disclosure system to allow for timely availability of information (e.g. study milestones, product approval/termination) that are relevant for transparency teams while also lead the thinking around implementation of new technologies. Cross-functional Governance - Bring specialized and advanced knowledge of disclosure requirements and standards to ensure quality of information shared publicly and ensure compliance with defined requirements. Work closely with the Medical Governance Boards, the Head Medical Governance, Head Publications and the Head Bioethics and Policy to ensure that GSK maintains its industry leading transparency ranking through a robust process for following policy including any exceptions or extensions. Strategic Leadership - Provide strategic direction and leadership in external working groups to develop common principles and standards to support clinical transparency and be a leader for GSK with industry-leading strategies in transparency. Maintain knowledge and expertise in Disclosure environment (Publications ethics and Privacy). Partner with key internal and external stakeholders to strengthen GSK practices for Policy requirements in line with relevant internal and external requirements. Develop strategies involving technology implementation and set targets to match the vision of an organization, creation of future business plans and required actions. Develop teams and partners to work with them by leveraging the synergy of wide variety of talent, while building a capacity that allows rapid implementation of tasks in order to achieve complex or cross-functional objectives. Minimum Level of Job-Related Experience Required Broad scientific/ pharmaceutical industry background with >10 years of experience in clinical research and/or in pharmaceutical industry , of which at least 8 years in Clinical Trial Transparency, Publications or Medical Writing. Extensive experience in Clinical Disclosure, Statistics or Programming with exposure to anonymisation techniques. Proficiency in GCP/ICH guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation), EMA Policy 70, Health Canada PRCI, GDPR, Privacy Laws, PhUSE, TransCelerate. Knowledge of PhRMA/EFPIA principles and related best practices Experience with Clinical Trial Disclosure software solution(s) Knowledge of GSK clinical/EPI/HE development activities and GCP Guidelines. Proven experience of managing and driving complex transversal projects involving senior management Previous line management experience of 5+ years is essential.

Hi, We are looking to hire someone for Study Data Manager Please go through the JD, we shall call back the relevant Profiles a) Experience in leading clinical studies. b) Experience on Study Conduct and Close Out JOB DECSRIPTION: Need exposure to Inform or Medidata Rave database • Responsible & Accountable for the assigned study conduct activities, in clinical trials • Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines. • Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. • To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). • SPOC for the study communications • Proactively highlight any risks associated with the study along with the mitigation plan. • Establish a partnership with the stakeholders at the operational level to work seamlessly to deliver the assigned project/activity as per timelines. • Identify process Improvement opportunities and ensure learning is shared • Ensure deliverables and/or agreed activities/tasks with customers. are completed with the expected quality. • Have worked on Study set-up, Study Conduct, and Study Closeout for various therapeutic areas. • Have also worked on writing edit check specifications, CRF completion guidelines, and review and corrections of set-up documents for different versions To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 184 b) For Position in Pune Search : Job Code # 185 C) For Position in Bangalore Search : Job Code # 186

Hi, We are hiring for Leading ITES Company for Lead Study Data Manager Profile Skills: a) Minimum 5 Years of Core Clinical Data Management Experience with minimum 1 year of experience of leading a clinical trial. . b) Experience on Study Conduct and Close Out c) Any Graduate JOB DECSRIPTION: Need exposure of Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and to ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customer. are completed with the expected quality. Have worked on Study set-up, Study Conduct and Study Close out for various therapeutic areas. Have also worked on writing edit check specification, CRF completion guidelines and review and corrections of set up documents for different versions. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 184 b) For Position in Pune Search : Job Code # 185 c) For Position in Bangalore Search : Job Code # 186

Hi , We are hiring for Leading ITES Company for SDTM Programmer Profile. Please go through the JD and we will get back to the relevant profiles. Job Description: Minimum 3 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Statistical Programmer Mumbai (Job Code # 208) b) For Position in Pune Search : Statistical Programmer Pune (Job Code # 209)

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Reviewer Mumbai (Job Code # 47) b) For Position in Pune Search : Medical Reviewer Pune (Job Code # 48) c) For Position in Bangalore Search : Medical Reviewer Bangalore (Job Code # 51)

Hi We are hiring for the leading ITES Company for the Medical Reviewer Role. Qualification - MBBS/MD is Must (Full TIme) Job Overview: The Medical Reviewer is responsible for the evaluation and analysis of clinical data to ensure accuracy, compliance with regulations, and the highest quality standards. This role involves reviewing clinical trial data, medical documentation, and regulatory submissions to support the approval of new medical products and therapies. Key Responsibilities: Clinical Data Review : Evaluate clinical trial data for completeness, accuracy, and adherence to protocols. Ensure data integrity and consistency across various documents and databases Medical Documentation: Review and verify the accuracy of medical documentation, including patient records, case reports, and clinical study reports. Ensure documentation complies with regulatory requirements and company standards. Regulatory Compliance: Stay updated with the latest regulatory guidelines and ensure all reviews align with current regulations. Prepare and review regulatory submissions to ensure timely and successful product approvals. Training and Development: Stay informed about advancements in medical research and regulatory changes. Participate in continuous training and development programs to enhance knowledge and skills. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Chennai Search : Medical Reviewer Chennai (Job Code # 52) b) For Position in Indore Search : Medical Reviewer Indore (Job Code # 53)

Hi We are Hiring Leading ITES Company for Medical Reviewer Role. Please go through the JD and Apply Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Ensure compliance with global and local procedural documents and local implementation of client Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Nagpur Search : Job Code # 49 b) For Position in Gandhinagar Search : Job Code # 50 c) For Position in Bangalore Search : Job Code # 51

We are Hiring for Leading ITES Company for Medical Reviewer Profile Pls Apply, We shall call back the relevant profiles. Experience :- Min 1 years of experience in Medical Reviewer domain Job Description for Medical Reviewer Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. • Ensure compliance with global and local procedural documents and local implementation of client. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 47 b) For Position in Pune Search : Job Code # 48 c) For Position in Nagpur Search : Job Code # 49

Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 181 b) For Position in Pune Search : Job Code # 182 C) For Position in Bangalore Search : Job Code # 183

Hi We're hiring for Leading ITES Company for EDC (Veeva Programmer) Role Experience in EDC & Veeva is Must. Job Description : Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,)) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks. Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit. Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. Adaptable to new ways of working using technology to accelerate clinical trial setup Education and Experience Requirements: Bachelor's degree or related experience. Knowledge of drug development process. Minimum of 4+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields. Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Experience programming in CQL, working with JSON format and/or C# is preferred Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint) To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : EDC Veeva & Inform Programmer Mumbai (Job Code # 181) b) For Position in Pune Search : EDC Veeva & Inform Programmer Pune (Job Code # 182) c) For Position in Bangalore Search : EDC Veeva & Inform Programmer Bangalore (Job Code # 183)

Hi, We are hiring for the ITES Company for the Clinical SAS + SQL Programmer Profile. Job Description: Minimum 4 years of experience in any CDMS application. To perform a wide range of Clinical Data Management activities resulting in high quality database within stipulated timelines. To provide expertise in programming concepts to the Data Management team Must be able to develop the connection with the stake holders by pro-actively communicating over the calls and handling the queries by resolving them on the spot or later depending on the nature of the problem. Must be able to contribute the solutions to the DMs or Medical scientist for their New requirements either programmatically or convincing them with the technical limitations, if any, along with providing alternative solution. Must have capability to develop new Macros in SAS or modify any SAS Macros that are used globally throughout studies as a part of automation. Preferred Skills: Excellent interpersonal and communication skills Capability to lead by motivation and exle. Strong knowledge in SAS macros is required. General knowledge of Clinical Trials and Pharmaceutical Industry Oracle/PL SQL, CDMS like SAS, Inform etc Key Skills: a) Minimum 4 years of experience in any Clinical Data Management application. b) Should have Oracle/PL SQL, CDMS like SAS, Inform etc c) Any Medical Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Pune Search: Job Code # 483 b) For Position in Bangalore Search: Job Code # 484 c) For Position in Hyderabad Search: Job Code # 485