Company: IQVIA

Location: Hyderabad, Telangana, India

Job Type: Full-Time

Referred By: Kapil Arun Patil

Responsibilities:

• Manage end-to-end Clinical Data Management tasks from protocol review to database lock.
• Develop and implement clinical data review/management plans and documents.
• Oversee Clinical Data Management vendors, ensuring data review and delivery.
• Author and revise DM-related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, and eCRF Completion Guidelines.
• Facilitate EDC build timeline and perform DB build tasks.
• Create test scripts and conduct UAT for Coding, Site Payment, and Safety Gateway.
• Collaborate with Data Management Lead in startup meetings.
• Ensure completion of startup documents as per SOP.
• Plan and execute Post Production/Migration for the study.
• Coordinate data review tasks and handle escalations with external vendors.
• Support Clean Patient Group delivery and update study documents as needed.
• Conduct Data Quality Review meetings and provide Data Health Metrics.
• Train and mentor junior CDM staff.

Must Have:

• Bachelor’s degree in Life Sciences, Pharmacy, or a relevant field.
• 6+ years of experience in clinical data management.
• Strong knowledge of EDC systems (Medidata RAVE preferred, Oracle Clinical).
• Expertise in clinical data management processes, FDA/ICH guidelines, and industry practices.
• Strong analytical skills and project management experience.
• Excellent oral and written communication skills.

Nice to Have:

• Knowledge of ICH-GCP guidelines and regulatory regulations.
• Understanding of GCPs, 21CFR Part 11, and data privacy.
• CCDM certification.

Application Link