Senior Clinical Data Manager
New
P
Precision for MedicineClinical trials
Remote, Hungary; Remote, Romania; Remote, Serbia; Remote, Slovakia; Remote, United Kingdom. We can consider candidates based in the 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 working for a Clinical Research Organisation, Pharmaceutical or Biotech company
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Bachelor’s degree and/or a combination of related experience.
- 8+ years’ 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.
- Experience with database setup and database migrations.
- Experience using various clinical database management systems.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
- Professional use of English, both written and oral.
- Broad knowledge of drug, device, and/or biologic development and effective data management practices.
- Strong leadership and interpersonal skills.
- Ability to undertake occasional travel.
- Oncology experience preferred.
Responsibilities
- Serve as the primary data management contact for assigned clinical projects or programs, ensuring continuity, responsiveness, and timely completion of tasks.
- Oversee data entry processes, including guidelines, training, quality, and resourcing.
- Develop CRF specifications from study protocols and coordinate stakeholder review and feedback.
- Conduct database build user acceptance testing and maintain quality-controlled database documentation.
- Specify and oversee edit check and manual data review requirements and specifications.
- Create, revise, version, and maintain data management documentation, including Trial Master File documentation.
- Review and query clinical trial data according to the Data Management Plan, and perform line listing reviews.
- Run patient- and study-level status and metric reports; perform medical coding and coordinate SAE/AE reconciliation.
- Coordinate with sponsors, vendors, and project teams on data, database, timelines, and project deliverables.
- Identify and troubleshoot operational issues using metrics, audit reports, and stakeholder input.
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