Job Summary:
The Senior CDA will support end-to-end clinical data management activities from study start-up to database lock. The role involves data review, query management, database testing, documentation preparation, and ensuring data quality in compliance with regulatory guidelines. The candidate will coordinate with cross – functional teams to ensure timely and accurate delivery of clinical data. Strong attention to detail, knowledge of CDM processes, and experience in clinical trials data handling are essential for this role.
Key Responsibilities:
- Serve as Lead CDA for assigned studies and act as backup for the Project Clinical Data Manager.
- Support the planning, execution, and oversight of clinical data management activities throughout the study lifecycle.
- Maintain awareness of project scope, timelines, and contractual obligations for assigned studies.
- Review and adhere to study-specific Clinical Data Management Plans (DMPs), SOPs, and applicable regulatory requirements.
- Design and/or review CRF/eCRF including visit structures in coordination with database programming teams.
- Review database specifications, edit check specifications, and Data Transfer Agreements (DTAs).
- Support database build activities and participate in database review, testing, and validation processes
- Identify database issues and interact with programmers to implement post-production database updates where required.
- Create and enter test data for User Acceptance Testing (UAT).
- Perform UAT for data entry screens, edit checks, listings, and targeted Source Data Verification (SDV) configurations and matrices.
- Ensure database functionality aligns with protocol requirements and study specifications.
- Conduct ongoing data review and perform data cleaning activities to ensure data accuracy and completeness.
- Generate, track, and resolve data clarification queries in coordination with investigational sites and study teams.
- Run and review data cleaning reports and study status reports.
- Perform quality review and internal QC checks within applicable Electronic Data Capture (EDC) systems.
- Support interim analyses, dry runs, data cuts, and database lock activities.
- Ensure consistency between the clinical database and external data sources such as central/local laboratory data, electronic diary data, pharmacokinetic (PK) data, and Interactive Response Technology (IRT) systems.
- Perform reconciliation activities including Serious Adverse Event (SAE) reconciliation and external vendor data review.
- Identify discrepancies in external data transfers and coordinate resolution with relevant stakeholders.
- Coordinate with clinical operations, biostatistics, programming teams, safety teams, and external vendors on data-related activities.
- Communicate timelines, task completion estimates, and potential resourcing conflicts to the project team and management.
- Participate in internal meetings, project discussions, and client interactions as required by the study schedule.
- May coordinate the work of CDAs assigned to the study and provide guidance on data management activities and systems.
- Provide training or knowledge-sharing on data management processes when required.
- Participate in internal and external audits and support audit readiness activities.
- Maintain proficiency in clinical data management systems and processes through regular training.
- Prioritize tasks effectively and adapt to changing project timelines and priorities.
- Ensure compliance with study procedures, regulatory requirements, and internal quality standards.
Skills :
- Strong knowledge of Clinical Data Management processes and clinical trial lifecycle.
- Experience working with EDC systems (such as Medidata Rave, Oracle Clinical, or similar platforms).
- Knowledge of CRF/eCRF design, edit checks, and database testing.
- Understanding of ICH-GCP guidelines and regulatory requirements.
- Experience in data cleaning, query management, and reconciliation activities (e.g., SAE reconciliation, external data review).
- Strong analytical, problem-solving, and attention to detail.
- Good communication and stakeholder coordination skills.
- Ability to manage multiple tasks and meet project timelines.
- Proficiency in MS Office tools (Excel, Word, PowerPoint).
Education:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related field.
- Certification or training in Clinical Research or Clinical Data Management will be an added advantage.
Experience:
- 5–6 years of experience in Clinical Data Management within a CRO, pharmaceutical, or clinical research organization.
- Hands-on experience with Electronic Data Capture (EDC) systems, database testing, data review, and query management.
- Experience in database build support, UAT, data cleaning, and reconciliation activities in clinical trials.
About company:
ProRelix Research (ProRelix Services LLP) is a global clinical research organization with presence in India and USA. We are a full service clinical trial solution provider with high reputation in industry. If you are passionate and possess enthusiasm to develop and embark on a fulfilling career in clinical research industry, we encourage you to apply.
Join us in out of box thinking environment where your skills and creativity will be admired for continuous personal growth.
Company website: www.prorelixresearch.com
To apply: [email protected]
Pay: ₹500,000.00 - ₹800,000.00 per year
Work Location: In person
