Clinical Data Manager

Position Summary:- • Role Summary • The Clinical Data Manager (CDM) is responsible for leading end-to-end data management activities across medical device clinical studies. This includes planning, execution, and close-out of studies while ensuring high-quality, compliant, and audit-ready data in alignment with global regulatory requirements. Key Responsibilities Study Start-Up Phase • Lead development and finalization of: • Data Management Plan (DMP), Data Validation Plan (DVP),CRF/eCRF design and annotation • Provide data collection input during protocol development • Coordinate with cross-functional teams for study start-up readiness • Oversee EDC build, User Acceptance Testing (UAT), and system validation • (e.g., Medidata Rave, Zelta EDC) • Define edit checks, validation rules, and data review listings 2. Study Conduct Phase • Oversee ongoing data cleaning and data review activities • Manage and track data queries: • Ensure timely generation, follow-up, and closure • Perform periodic data review and trend analysis Collaborate with: • Clinical Operations (CRA team), Biostatistics,Medical/Regulatory teams • Ensure protocol compliance in data collection • Monitor key data metrics (missing data, discrepancies, turnaround time) • Support interim data extracts and analysis activities 3. Study Close-Out Phase • Lead database lock activities: • Data reconciliation (SAE, device, lab, imaging data) • Query closure and final data cleaning • Ensure completeness and accuracy of final datasets Support: • Annual Progress Report (APR) and Clinical Study Report (CSR) • Archive study data and ensure proper documentation in eTMF • Participate in lessons learned and process improvement initiatives Quality & Compliance • Ensure adherence to global regulatory and quality standards: • ISO 14155, ICH GCP ,21 CFR Part 11 • Maintain audit-ready documentation and traceability • Support internal audits, sponsor audits, and regulatory inspections • Ensure compliance with SOPs, data integrity principles, and ALCOA+ • Identify risks and implement corrective and preventive actions (CAPA) • Drive continuous improvement and standardization across studies Qualifications • Bachelor’s or Master’s in Life Sciences, Pharmacy, Biotechnology, or related field • 8–10 years of clinical data management experience (medical device preferred) • Experience handling global/multi-center clinical studies Technical Skills • Strong experience with EDC systems (Rave, Zelta, Oracle Clinical, etc.) • Understanding of data standards: • CDISC SDTM (working knowledge) • Experience with data validation, discrepancy management, and listings • Familiarity with eTMF systems (e.g., SharePoint-based, Medidata) • Advanced Excel and reporting skills Soft Skills • Strong stakeholder communication and collaboration • High attention to detail and data quality mindset • Ability to manage multiple studies and priorities • Leadership and mentoring capability Key Performance Indicators (KPIs) • Timeliness of database build and go-live • Query resolution turnaround time • On-time database lock • Data quality (error rate, missing data trends) • Audit/inspection readiness (minimal findings) Preferred Medical Device Experience • Imaging/core lab data reconciliation • Device accountability and tracking • Adverse Device Effects (ADE) handling • Post-Market Clinical Follow-up (PMCF) studies