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.
