Clinical Data Manager

▌Role Summary
The Clinical Data Manager is responsible for the end-to-end management of clinical trial data, including database build oversight, data quality control, EDC configuration, change management, and study-level data deliverables.

This role requires strong hands-on experience with Electronic Data Capture (EDC) systems and the ability to independently manage database activities from study start-up through database lock. While experience with multiple EDC platforms is valuable, proficiency in Medidata Rave is a plus.

The successful candidate will ensure high-quality, compliant, and inspection-ready clinical data in a fast-paced CRO environment.

▌Key Responsibilities:

• Manage clinical data activities from study start-up through database lock.
• Configure and/or oversee study databases within EDC systems.
• Design and review CRFs, edit checks, visit structures, and user roles.
• Coordinate UAT, database go-live, mid-study updates, and lock readiness.
• Monitor data quality, review queries, and identify data trends or issues.
• Manage change control, versioning, and study documentation.
• Support reconciliation of external data sources as applicable.
• Collaborate with cross-functional teams to ensure timely and compliant data deliverables.
• Maintain inspection-ready documentation in accordance with GCP and regulatory standards.

▌Required Qualifications

• Bachelor or above degree in Life Sciences or related field.
• 3+ years of experience in clinical data management within pharmaceutical, biotech, or CRO settings.
• Less than 3 years of experience can be also considered
• Strong hands-on experience working with at least one major EDC platform.
• Demonstrated experience managing database build, UAT, mid-study updates, and database lock.
• Solid understanding of:
• GCP and data integrity principles
• Clinical data standards (e.g., CDASH; familiarity with SDTM concepts preferred)
• Change control and validation processes in regulated environments
• Ability to manage multiple concurrent studies under defined timelines.

▌Preferred Qualifications

• Experience working with EDC systems (e.g., Rave EDC).
• Experience with Rave study build is a plus
• Experience integrating and reconciling external or non-traditional data sources.
• Experience supporting regulatory inspections or sponsor audits.
• Experience in complex therapeutic areas (e.g., oncology, ophthalmology, rare disease).