Location: India
Job Type: Full-Time
Experience Required: Minimum 5+ years (Not suitable for freshers)
About the Role
We are hiring an experienced Senior Clinical Data Manager to lead and execute end-to-end clinical data management activities across global clinical trials. This role is critical in ensuring high-quality, compliant, and audit-ready clinical data from study start-up to database lock. The position requires strong expertise in EDC systems, clinical trial data standards, and cross-functional collaboration within the pharmaceutical and CRO environment.
Key Responsibilities
Perform comprehensive clinical data management activities from study start-up through database lock
Ensure delivery of high-quality, consistent, and regulatory-compliant clinical data aligned with protocol requirements
Lead full projects independently or manage key components with minimal supervision
Maintain audit-ready documentation in compliance with SOPs, ICH-GCP, and regulatory guidelines
Coordinate data management timelines, deliverables, and budget adherence
Collaborate with internal teams, sponsors, and external stakeholders for clinical and technical decision-making
Identify project risks and proactively escalate issues impacting timelines or deliverables
Design and develop EDC components including eCRFs, edit checks, and casebooks
Create and manage essential data management documents such as Data Management Plan (DMP), Data Validation Specifications, eCRF Completion Guidelines, and Data Transfer Agreements
Conduct and oversee User Acceptance Testing (UAT)
Train EDC users and manage user access, ensuring smooth system operations
Lead data cleaning activities including SAE reconciliation and external data reconciliation
Assess protocol amendments and implement database changes through change request processes
Drive database lock activities including QC checks, timelines, and final data review reports
Support development of internal processes, SOPs, and departmental guidelines
Mentor and train junior data management professionals
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Computer Science, or a related discipline
Minimum 5 years of progressive experience in Clinical Data Management or Clinical Research
Strong understanding of clinical trial lifecycle and data management processes
Technical Skills and Competencies
Hands-on experience with EDC tools such as Medidata Rave, Oracle InForm, Medrio, VieDoc, or Merative Zelta
In-depth knowledge of ICH-GCP, 21 CFR Part 11, and global regulatory requirements
Familiarity with CDISC standards (SDTM, CDASH) for clinical data handling
Strong proficiency in Microsoft Office (Excel, Word, PowerPoint)
Excellent analytical, problem-solving, and data interpretation skills
Strong communication and stakeholder management abilities
Ability to work independently and collaboratively in a fast-paced clinical research environment
Detail-oriented mindset with strong project management capabilities
Why This Role is Important
Clinical Data Management is the backbone of clinical trials. As a Senior Clinical Data Manager, you will directly contribute to data integrity, regulatory compliance, and successful drug development outcomes, impacting global patient safety and healthcare innovation.
Important Note for Applicants
This is a senior-level role requiring hands-on experience in clinical data management. Freshers or entry-level candidates should consider roles such as Clinical Data Coordinator or Junior Clinical Data Manager to build foundational experience before applying to this position.
How to Apply
Explore more verified Clinical Data Management jobs in India and globally on ThePharmaDaily.com and stay updated with the latest pharma, CRO, and clinical research career opportunities.
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