Clinical Data Manager II/Senior Clinical Data Manager
$47,550–$71,350 year
Remote · United Kingdom or Poland
Job Summary
Lead the clinical data management activities for assigned trials from study start-up through database lock, acting as Primary DM for projects and ensuring timely, high-quality data delivery. Responsibilities include overseeing data entry guidelines and QA, developing CRF specifications, coordinating CRF review with stakeholders, conducting DB build UAT, defining edit checks, maintaining DM documentation and TMF completeness, training personnel on DM processes, reviewing data per Data Management Plan, performing line-listing reviews, generating project metrics, coordinating SAE/AE reconciliation with sponsors and external vendors, and supporting SAS programming or QA of SAS outputs as required. Travel may be required. Oncology experience and familiarity with CRO/pharma data management practices are preferred.
Required Qualifications
- Bachelor's degree or equivalent experience in a related field
- 8+ years’ experience as a Senior Clinical Data Manager or 5+ years as a Clinical Data Manager II in CRO/pharma/biotech settings
- Experience with data management systems
- Oncology experience preferred
- Proficiency in Microsoft Office
- Excellent organizational and communication skills
- English proficiency (written and oral)
- Ability to travel occasionally
- Experience in CRF specification, EDC, SAP/CAR processes, and TMF documentation
- Strong leadership and interpersonal skills
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