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 manages all aspects of the clinical trial data management process, from study start-up to database lock.
Role Involves: - Acting as the primary Data Management contact for assigned projects.
- Overseeing the project data entry process.
- Managing timelines and resource needs.
- Developing CRF specifications.
- Conducting database build UAT.
- Overseeing the quality of the clinical database.
- Creating and maintaining data management documentation.
- Training clinical research personnel.
- Reviewing and querying clinical trial data.
- Performing medical coding.
- Liaising with third-party vendors.
- Identifying and troubleshooting operational issues.
Requirements: - Bachelor's degree or related experience.
- 8+ years of experience with Oncology and/or Orphan Drug therapeutic experience.
- Experience in 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.
- Broad knowledge of drug, device, and/or biologic development.
- Excellent organizational, communication, and representational skills.
- Professional use of the English language (written and oral).
- Strong leadership and interpersonal skills.
- Ability to undertake occasional travel.
Role Offers: - Remote work opportunity.
- Opportunity to work with a growing Data Management team.