Clinical Data Manager II / Senior Clinical Data Manager
New
P
Precision for MedicineClinical Research
Remote, CanadaFull-TimeSenior
Salary92,500 - 167,900 USD per year
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Job Details
- Languages
- English
- Experience
- 8+ years as a Sr. Clinical Data Manager and 5 years as a Clinical Data Manager II
Requirements
- Bachelors degree or equivalent combination of experience.
- 8+ years of experience as a Senior Clinical Data Manager.
- 5+ years of experience as a Clinical Data Manager II.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Experience using various clinical database management systems.
- Broad knowledge of drug, device, and biologic development.
- Excellent organizational and communication skills.
- Professional fluency in English, written and oral.
- Strong leadership and interpersonal skills.
- Ability to undertake occasional travel.
Responsibilities
- Serve as primary Data Management (DM) contact for assigned clinical projects.
- Oversee project data entry processes and ensure quality control.
- Develop CRF specifications and coordinate stakeholder feedback.
- Conduct database build UAT and manage quality-controlled documentation.
- Specify requirements for edit checks and manual data review.
- Maintain data management documentation and Trial Master File completeness.
- Perform medical coding (MedDRA/WHODrug) and SAE/AE reconciliation.
- Liaise with external data and EDC vendors to manage deliverables.
- Participate in the development and maintenance of SOPs.
- Provide leadership for cross-functional and organization-wide initiatives.
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