Precision Medicine Group is seeking a Senior Clinical Data Manager to join their European team. This role is fully remote and can be based in the UK, Spain, Poland, Slovakia, Romania, Hungary, or Serbia. The Senior Clinical Data Manager will manage all aspects of the clinical trial data management process from study start-up to post-database lock. He/she will follow Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study-specific plans and guidelines. This position includes overseeing and/or performing database development and testing.
Role Involves: - Serving as the primary Data Management (DM) contact for assigned clinical projects.
- Overseeing the project data entry process.
- Providing input to manage timelines.
- Developing CRF specifications.
- Conducting database build UAT.
- Performing medical coding of medical terms.
Requirements: - Bachelor's degree and/or related experience.
- 8+ years’ experience with Oncology and/or Orphan Drug therapeutic experience.
- Dictionary medical coding (MedDRA and WHODrug).
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
- Experience in utilizing various clinical database management systems.
- Proficiency in Microsoft Office.
- Strong leadership and interpersonal skills.
Role Offers: - Remote work opportunity.
- Opportunity to work with a growing Data Management team.