Project Role: Director – Clinical Data Programming

Work Experience: 15–20 Years, including 5+ years in people leadership, portfolio management, and strategic delivery leadership within a CRO or Pharmaceutical environment

Work Location: Bengaluru (or other India delivery hubs)

Work Mode: Hybrid

Must Have Skills: Clinical Data Programming, SAS Programming, Rave or Veeva, Clinical Data Management Leadership, People Management, Portfolio Leadership

Job Overview:

The Director – Clinical Data Programming is responsible for providing strategic leadership and operational oversight for clinical data programming, database setup, and clinical data management delivery across multiple sponsors and therapeutic areas. This role drives delivery excellence, strengthens sponsor partnerships, ensures regulatory compliance, and leads global teams supporting clinical trial execution within FSP and Full-Service models.

Job Responsibility:

- Provide strategic and portfolio-level leadership for clinical data programming and database setup activities across multiple studies and programs.
- Act as the senior sponsor-facing leader for delivery governance, operational reviews, issue resolution, and relationship management.
- Lead global and offshore teams responsible for EDC study builds, edit check programming, database configuration, and data management activities.
- Drive operational excellence through standardized processes, quality oversight, KPI management, risk mitigation, and continuous improvement initiatives.
- Oversee study startup activities, database readiness, timelines, milestones, and database lock deliverables.
- Lead workforce planning, resource allocation, utilization management, and succession planning across programming teams.
- Support business growth through proposals, RFP responses, bid defenses, solutioning, budgeting, and scope management.
- Develop and maintain executive-level relationships with pharmaceutical,



biotechnology, and medical device sponsors.
- Mentor and develop senior managers, associate directors, and high-potential talent within the organization.
- Drive innovation, automation, and technology adoption to improve efficiency, quality, and scalability.

Technical/Required Skills:

- 15–20 years of experience in Clinical Data Management, Clinical Data Programming, Database Setup, and Study Startup activities.
- Solid hands-on expertise in SAS Programming and experience with Medidata Rave or Veeva.
- Strong understanding of EDC build lifecycle, edit check programming, forms design, data review, and database management processes.
- Proven experience managing large global portfolios across multiple sponsors and therapeutic areas.
- Deep knowledge of GCP, ICH Guidelines, FDA, EMA, and global regulatory requirements.
- Experience leading FSP and Full-Service delivery models within a global CRO environment.
- Strong leadership, stakeholder management, portfolio governance, and risk management capabilities.
- Experience managing geographically distributed and cross-functional teams.
- Financial and operational management experience including budgeting, forecasting, utilization, productivity, and margin management.

Good to Have Skills/Experience:

- Experience with Spotfire, Power BI, Clean Patient Tracker (CPT), and reporting/analytics tools.
- Knowledge of CDISC standards including SDTM and ADaM.
- Exposure to clinical data integrations, automation initiatives, and digital transformation programs.
- Experience managing large pharmaceutical and biotechnology client portfolios.
- Experience supporting regulatory inspections, audits, and sponsor governance activities.
- Experience driving process improvement and technology transformation initiatives.

Educational Qualification:

Bachelor’s or Master’s Degree in Life Sciences, Pharmacy, Computer Science, Statistics, Information Technology, or a related discipline.

📌 Director – Clinical Data Programming (Bengaluru)
🏢 Iqvia
📍 Bengaluru