Senior Clinical Data Manager at Precision for Medicine

Precision Medicine Group is seeking a Senior Clinical Data Manager to join their European team. This is a remote position based in Poland. The Senior Clinical Data Manager will be responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock.

Responsibilities:

• Serve as the primary Data Management (DM) contact for assigned clinical projects.
• Oversee project data entry, ensuring quality and resource allocation.
• Develop CRF specifications and coordinate feedback from stakeholders.
• Conduct database build User Acceptance Testing (UAT) and maintain documentation.
• Oversee the quality of the clinical database.
• Develop and maintain data management documentation.
• Train clinical research personnel on study-specific items.
• Review and query clinical trial data according to the Data Management Plan.
• Perform medical coding and coordinate SAE/AE reconciliation.
• Liaise with third-party vendors.
• Identify and troubleshoot operational problems.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs).
• Communicate with study sponsors, vendors, and project teams.

Requirements:

• Bachelor's degree and/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.).
• 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.
• Strong leadership and interpersonal skills.

The role offers:

• Remote work opportunity