Work Experience: 12–18 years
Work location: Pan India
Work Mode: Hybrid
Must Have Skills: Clinical Data Management Leadership, Rave/Veeva Programming, DB Setup & Validation Oversight, People Management
Job Overview:
The Associate Director – Clinical DB Validation is responsible for leading and overseeing high-quality database setup, programming, and validation delivery across multiple clinical studies within an FSP model. This role provides strategic leadership, strong sponsor partnership, operational oversight, and people management to ensure compliant, efficient, and inspection-ready clinical trial execution.
Job Responsibility:
- Provide portfolio-level oversight of database setup and validation activities from study startup through database lock.
- Act as the senior point of contact for sponsors for DB setup and validation governance, communication, and escalations.
- Lead delivery across FSP and support teams, ensuring consistent quality and performance.
- Drive adherence to CRO and sponsor SOPs, KPIs, and global regulatory requirements.
- Oversee study milestones, ensure inspection readiness, and participate in audits and regulatory inspections.
- Lead, mentor, and develop junior staff and global/offshore delivery teams.
- Support proposals, RFP responses, bid defenses, and scope/change management activities.
- Provide portfolio-level support and oversight assignments as required.
Technical/Required Skills:
- Strong expertise in Clinical Data Management, Clinical DB Validation, and study startup processes across the trial lifecycle.
- 12–16 years of relevant experience in Clinical Data Management (Startup), Clinical DB Testing, or Database Setup, with strong experience on the Medidata Rave platform.
- Hands-on experience with validation/programming of study setup and migrations across EDC platforms such as Medidata Rave, Veeva CDMS, Oracle Clinical, or Inform.
- 5+ Years of experience in people management.
- In-depth knowledge of GCP, ICH, FDA, EMA, and global regulatory requirements.
- Proven delivery management experience across multiple sponsors and therapeutic areas.
- Strong leadership, risk management, and stakeholder communication skills.
- Experience managing global and offshore CDM and validation teams.
Good to have Skills/Experience:
- Experience supporting RFPs, bid defenses, and sponsor governance activities.
- Financial and operational exposure including utilization, productivity, and margin management.
- Ability to manage multiple projects and priorities simultaneously.
- Exposure to Spotfire, Clean Patient Tracker, and EDC build activities.
- Experience working with large pharmaceutical companies and global CROs.
Educational Qualification:
- Bachelor's Degree in Science, Computer Science, Information Technology, or Bachelor of Technology (Required)
