Associate Director-Clinical Data Validation

IQVIA; Bengaluru; Hybrid; INR 4,200,000 - 6,000,000; Full time

Job summary

IQVIA in Bengaluru is seeking an Associate Director Clinical DB Validation to lead database setup, programming, and validation across multiple clinical studies within an FSP model.

This senior role requires strategic leadership, strong sponsor partnership, and operational oversight to ensure compliant, efficient, and inspection-ready clinical trial execution. The candidate will manage global/offshore delivery teams and drive adherence to global regulatory standards.

Qualifications

• Experience in Clinical Data Management, DB Validation, and study startup processes.
• Strong understanding of GCP/ICH/FDA regulatory requirements.
• Experience leading offshore/global delivery teams.

Responsibilities

• Provide portfolio-level oversight of database setup and validation from startup to DB lock.
• Senior point of contact for sponsors for DB setup governance and escalations.
• Lead delivery across FSP and support teams, ensuring quality and performance.
• Ensure adherence to SOPs, KPIs, and global regulatory requirements.
• Oversee study milestones, inspection readiness, audits, and inspections.
• Mentor and develop junior staff and offshore delivery teams.
• Support proposals, RFPs, bid defenses, and scope/change management.

Skills

Clinical Data Management Leadership

Rave/Veeva Programming

DB Setup & Validation Oversight

People Management

Education

Bachelor's Degree (Science/CS/IT/B.Tech)

Tools

Medidata Rave

Veeva CDMS

Oracle Clinical

Inform

Job description

Work Experience:

1218 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.
• 1216 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:

Bachelors Degree in Science, Computer Science, Information Technology, or Bachelor of Technology (Required).