Clinical Data Manager II / Senior Clinical Data Manager
New
P
Precision Medicine GroupClinical Trials
Remote, CanadaFull-TimeSenior
Salary91,500 - 166,100 USD per year
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Job Details
- Languages
- English
- Experience
- 8+ years’ experience 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’ experience as a Sr. Clinical Data Manager and 5 years as a Clinical Data Manager II.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Experience with various clinical database management systems.
- Broad knowledge of drug, device, and/or biologic development.
- Strong organizational, communication, and interpersonal skills.
- Professional English proficiency (written and oral).
- Experience in clinical, scientific, or healthcare discipline (preferred).
- Knowledge of dictionary medical coding (MedDRA and WHODrug) (preferred).
- Understanding of CDISC standards (CDASH, SDTM, ADaM) (preferred).
- Oncology and/or Orphan Drug therapeutic experience (preferred).
Responsibilities
- Serve as primary Data Management contact for assigned clinical programs.
- Oversee project data entry, training, and quality control.
- Develop CRF specifications and coordinate stakeholder review.
- Conduct database build UAT and maintain quality control documentation.
- Create and maintain data management documentation including the Trial Master File.
- Train clinical research personnel on CRF, EDC, and project items.
- Review clinical trial data and perform medical coding (MedDRA/WHODrug).
- Coordinate SAE/AE reconciliation and liaise with third-party vendors.
- Identify and troubleshoot operational issues based on metrics.
- Provide leadership for cross-functional and organization-wide initiatives.
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