Senior Clinical Data Manager

About the role

Senior Clinical Data Manager leads data management for external vendor data in clinical trials. Oversees development of Vendor Data Plans, ensures data quality, and manages DM deliverables from start‑up to database lock. Acts as subject‑matter expert in sponsor meetings, mentors junior staff, and maintains compliance with SOPs, GCP, and regulatory requirements. Coordinates timelines with cross‑functional teams, tracks scope changes, and builds client relationships. Requires 8+ years of DM experience, strong project management, and proficiency in EDC, SAS, statistics, and PK. English fluency mandatory. Remote or office‑based in Bangalore, India.

What you’ll do

• Develop Vendor Data Plan and approve TMF filing.
• Ensure external vendor data meets protocol specs.
• Lead studies across healthy volunteer and patient populations.
• Act as Study Manager, oversee DM deliverables and timelines.
• Maintain compliance with protocols, SOPs, GCP.
• Coordinate timelines with PM and cross-functional teams.
• Lead DM project team meetings and risk mitigation.
• Support Biometrics group deliverables and resource planning.
• Communicate project status to PM, sponsors, and management.
• Inventory and manage data from sites and vendors.
• Build and maintain client relationships and satisfaction.
• Track scope changes and secure sponsor approvals.
• Mentor and coach DM staff on processes and performance.
• Stay current with DM technologies and process improvements.
• Review and update SOPs and documentation.
• Maintain accurate records and perform database reconciliations.
• Represent DM in business opportunities and audits.
• Promote Biometrics services to sponsors.
• Perform additional duties as assigned.

What you’ll bring

• Bachelor’s degree or equivalent experience.
• English speaking/writing/reading required.

Nice to have

• Life sciences/health sciences/IT degree preferred.
• Knowledge of Fortrea SOPs.
• 4+ years EDC experience.

Skills

Education

College degree