Senior Clinical Data Manager

New

Precision for MedicineClinical trials

Remote, Hungary; Remote, Romania; Remote, Serbia; Remote, Slovakia; Remote, United KingdomFull-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

Have a bachelor’s degree and/or a combination of related experience.
Have 8+ years of experience as a Senior Clinical Data Manager, or 5+ years as a Clinical Data Manager II.
Have experience working for a Clinical Research Organisation, pharmaceutical company, or biotech company.
Have clinical database setup and database migration experience.
Have experience using clinical database management systems.
Be proficient in Microsoft Word, Excel, PowerPoint, and Outlook.
Have professional written and spoken English language skills.
Have broad knowledge of drug, device, and/or biologic development and effective data management practices.
Have strong organizational, leadership, and interpersonal skills.
Be able to communicate effectively orally and in writing.
Be able to undertake occasional travel.

Serve as the primary Data Management contact for assigned clinical projects or programs.
Oversee data entry processes, including guidelines, training, quality, and resourcing.
Assess project timelines and resource needs, and help ensure clinical data management deadlines are met.
Develop or oversee CRF specifications, database builds, user acceptance testing, and edit check specifications.
Create, revise, version, and maintain data management documentation and oversee Trial Master File completeness.
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, and perform medical coding for consistency.
Coordinate SAE/AE reconciliation and liaise with third-party vendors on timelines and data-related deliverables.
Identify and troubleshoot operational issues using metrics, audit reports, and stakeholder input.
Communicate with sponsors, vendors, and project teams about data, database, and project issues.

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