IQVIA

Assoc Clin DB Validation Dir

Kochi, India Full time

IQVIA is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the Merger of IMS Health and Quintiles, IQVIA applies human data science – leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science – to enable companies to reimagine and develop new approaches to clinical development and commercialization, speed innovation, and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE, we deliver unique and actionable insights at the intersection of large-scale analytics, transformative technology, and extensive domain expertise as well as execution capabilities. With approximately 86,000+ employees, we conduct operations in more than 100 countries.

IQVIA has also featured in FORTUNE’s 2026 List of “World’s Most Admired Companies”. At IQVIA, you will have the opportunity to build your career, while helping our customers drive human health outcomes forward. We dedicate our experience, resources, and reputation so that you can drive your career and choose the path that best defines your development and success.


Project Role:  Associate Director – Clinical Data Validation

Work Experience:  10–14 years of progressive experience in Clinical Data Management, including 5+ years in people, program, or portfolio leadership within a CRO environment.

Work location:  Bengaluru (or other India delivery hubs)

Work Mode: Hybrid

Must Have Skills:

  • Clinical Data Management leadership in a CRO setting.
  • Sponsor and stakeholder management (FSP and/or Full‑Service models)
  • Oversight of study setup activities.
  • CRO delivery excellence (quality, timelines, utilization).
  • Audit and inspection readiness.
  • Project Finance

Job Overview:

The Associate Director – Clin DB Validation is charged with leading and supervising the delivery of high-quality database programming and/or validation teams across multiple clinical studies within FSP. The role provides strategic leadership, client partnership, operational oversight, and people management within FSP ensuring compliant, efficient, and inspection‑ready trial execution.

Job Responsibility:

  • Provide portfolio‑level oversight of DB setup & validation activities from study startup through database lock.
  • Act as senior DB setup & validation contact for sponsor interactions, governance, and escalations.
  • Lead delivery across FSP & Support team as needed.
  • Drive adherence to CRO and sponsor SOPs, KPIs, and regulatory requirements.
  • Oversee study milestones, ensure inspection readiness and lead PSS participation in audits and inspections.
  • Lead, mentor, and develop junior staff and global delivery teams.
  • Support proposals, RFP responses, bid defenses, and scope/change management as required.
  • Support assignments on portfolio as needed.

Technical/Required Skills:

  • Strong expertise in Clinical Data Management/Validation/Study Startup processes and lifecycle
  • Hands‑on experience with validation/programming of study set up, migrations across any EDC platform (Medidata Rave, Veeva CDMS, Oracle/Inform)
  • Knowledge of GCP, ICH, FDA, EMA, and global regulatory expectations
  • Delivery management across multiple sponsors and therapeutic areas
  • Strong communication, risk management, and leadership skills
  • Experience managing global and offshore CDM teams

Good Skills/Experience:

  • RFP, bid defense, and sponsor management
  • Financial and operational exposure (utilization, productivity, margin)
  • Experience handling multiple projects, Multitasking, exposure to Spotfire & Clean Patient Tracker, EDC build would be of added value.
  • Experience working with large pharma and CROs

Educational Qualification:

• Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology  Req
• 12- 16 years of relevant Data Management (Startup) or Clinical DB Testing or Database Setup experience in Rave Platform.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.