Senior Clinical Data Manager
New
P
Precision for MedicineClinical trial services
Remote, Brazil; Remote, Colombia; Remote, MexicoFull-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 for a Sr. Clinical Data Manager
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Have a bachelor’s degree and/or a combination of related experience.
- Have 8+ years’ experience for a Senior Clinical Data Manager.
- Be proficient in Microsoft Office: Word, Excel, PowerPoint, and Outlook.
- Have experience utilizing clinical database management systems.
- Have broad knowledge of drug, device, and/or biologic development and effective data management practices.
- Use English professionally in written and oral communication.
- Be able to handle a variety of clinical research tasks.
- Bring strong organizational, communication, leadership, and interpersonal skills.
- Be able to undertake occasional travel.
Responsibilities
- Serve as the primary data management contact for assigned clinical projects or programs, ensuring continuity, responsiveness, and timely task completion.
- Oversee data entry processes, including guidelines, training, quality, and resourcing.
- Develop CRF specifications from clinical study protocols and coordinate stakeholder review and feedback.
- Oversee database development and quality, conduct database build UAT, and maintain controlled build documentation.
- Specify and oversee edit check and manual data review specifications.
- Create, revise, version, and maintain data management documentation, including documentation for the Trial Master File.
- Review and query clinical trial data, perform line listing reviews, and run patient- and study-level status and metric reports.
- Perform medical coding and coordinate SAE/AE reconciliation.
- Coordinate with third-party vendors, sponsors, and project teams on data, database, timelines, and project deliverables.
- Identify operational issues using metrics, audit reports, and stakeholder input; support SOPs, process documentation, and cross-functional initiatives.
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