Clinical Data Manager II / Senior Clinical Data Manager
P
Precision for MedicineClinical Trial Services
We can consider candidates based in the UK, Poland, Hungary, Romania, Serbia or Slovakia.Full-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Professional use of the English language; both written and oral
- Experience
- 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree and/or a combination of related experience.
- 8+ years of experience as a Senior Clinical Data Manager OR 5+ years as a Clinical Data Manager II.
- Experience working for a Clinical Research Organisation, Pharmaceutical, or Biotech company.
- Direct experience in study setup and database migrations.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Experience utilizing various clinical database management systems.
- Broad knowledge of drug, device, and/or biologic development processes.
- Professional English language proficiency, both written and oral.
- Strong leadership, interpersonal, organizational, and communication skills.
- Ability to undertake occasional travel.
Responsibilities
- Serve as primary Data Management (DM) contact for assigned clinical projects, ensuring continuity and responsiveness.
- Oversee project data entry processes, including guideline development, training, and quality control.
- Coordinate the build of clinical databases, conducting User Acceptance Testing (UAT) and maintaining documentation.
- Develop and maintain clinical data management documentation, including Data Management Plans and Trial Master File content.
- Perform medical coding, SAE/AE reconciliation, and review of clinical trial data.
- Liaise with third-party vendors, such as external data and EDC providers, in a project management capacity.
- Train clinical research personnel on study-specific CRF, EDC, and other related items.
- Identify and troubleshoot operational issues based on study metrics, audit reports, and team input.
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