Job Responsibilities:
- Manage end-to-end Clinical Data Management tasks, including protocol review, CRF design, and database lock, in line with organization SOPs.
- Develop and implement clinical data review/management plans and prepare related documents.
- Set up and oversee Clinical Data Management vendors, ensuring data review and timely delivery.
- Handle EDC systems (Medidata RAVE preferred, Oracle Clinical) and manage query trend analysis, protocol deviation review/reporting, and study timelines.
- Author, review, and revise DM-related study plans, such as Data Quality Management Plan, Data Validation Plans, and eCRF Completion Guidelines.
- Maintain strong knowledge of Clinical Drug Development processes, FDA/ICH guidelines, and submission requirements (e.g., NDAs, BLAs, MAAs).
- Lead Data Quality Review meetings and represent DM on cross-functional teams and submission teams.
- Provide oversight, coaching, and mentoring to Data Management teams.
- Support Health Authority inspections, audits, and project management tasks to ensure timely and quality study delivery.
Qualifications:
Must Have:
- Bachelor’s Degree in Life Sciences, Pharmacy, or related fields.
- 6+ years of experience in Clinical Data Management.
- Strong knowledge of EDC systems (Medidata RAVE preferred).
- Experience with clinical operations, query trend analysis, study deliverables, and cross-functional team collaboration.
- Excellent project management, communication, and analytical skills.
Nice to Have:
- CCDM certification.
- Knowledge of ICH-GCP, 21CFR Part 11, and data privacy regulations.
- Solid understanding of GCPs and data handling in clinical research.
Responsibilities Include:
- Draft EDC build timelines and perform DB build tasks.
- Create and finalize study documents, collaborate with external vendors, and support data quality review.
- Provide training and mentoring to junior CDM staff.
