Senior Clinical Data Manager

About the role

The Clinical Data Manager II or Senior Clinical Data Manager manages all aspects of the clinical trial data management process from study start-up to post-database lock. This role ensures data quality, oversees database development and testing, and serves as the primary data management contact for assigned clinical programs.

Responsibilities

• Serve as the primary Data Management contact for assigned clinical projects and programs.
• Oversee project data entry processes, including guidelines, training, and quality control.
• Manage timelines and assess resource needs to ensure clinical data management deadlines are met.
• Develop CRF specifications and coordinate stakeholder reviews.
• Conduct database build UAT and maintain quality-controlled documentation.
• Perform medical coding and coordinate SAE/AE reconciliation.
• Liaise with third-party vendors and EDC providers to support project deliverables.

Required skills

• Clinical Data Management
• Database build
• UAT
• CRF specifications
• Medical coding
• EDC
• Clinical trial data management

Nice to have

• Oncology
• SAS programming

Qualifications

• Bachelor's degree or equivalent combination of related experience
• 8+ years of experience as a Sr. Clinical Data Manager or 5+ years as a Clinical Data Manager II in a CRO, Pharmaceutical, or Biotech company
• Experience with database set up and migrations