Senior Clinical Data Manager at Precision for Medicine

Precision Medicine Group is seeking a Senior Clinical Data Manager to join their European team. This role is fully remote within the UK, Spain, Poland, Slovakia, Romania, Hungary, or Serbia. The Senior Clinical Data Manager manages all facets of the clinical trial data management process, from study inception to database lock. They will adhere to Standard Operating Procedures, regulatory guidelines, and study-specific plans. The manager will also oversee database development and testing.Role Involves:

• Serving as the primary Data Management contact for assigned clinical projects.
• Overseeing the project data entry process.
• Providing input and managing timelines.
• Developing CRF specifications.
• Conducting database build UAT.
• Overseeing the quality of the clinical database.
• 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 or Orphan Drug trials.
• Experience in dictionary medical coding (MedDRA and WHODrug).
• Understanding of CDISC standards (CDASH, SDTM, ADaM).
• Experience utilizing various clinical database management systems.
• Proficiency in Microsoft Office.
• Knowledge of drug, device, and/or biologic development.
• Excellent organizational, communication, and representational skills.
• Professional use of the English language.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.

Role Offers:

• Remote work opportunity.