Clinical Data Manager
P
Precision for MedicineClinical Trial Services
Mexico, Brazil, Argentina, Colombia, Chile, and PeruFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 8+ years for Sr. Clinical Data Manager; 10+ years for Principal Clinical Data Manager
- Required Skills
- Microsoft Office
Requirements
- Bachelor's degree or equivalent combination of related experience.
- 8+ years of clinical data management experience for Sr. level; 10+ years for Principal level.
- Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Outlook).
- Professional fluency in written and oral English.
- Demonstrated experience utilizing various clinical database management systems.
- Broad knowledge of drug, device, and/or biologic development processes.
- Strong leadership, interpersonal, and communication skills.
- Ability to undertake occasional travel.
- Experience with 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 projects.
- Oversee project data entry, training, quality control, and resourcing.
- Develop CRF specifications and coordinate stakeholder feedback.
- Build and maintain clinical databases, including UAT and documentation.
- Create and oversee edit check and data review specifications.
- Manage Trial Master File documentation and ensure regulatory compliance.
- Train research personnel on study-specific CRF and EDC systems.
- Conduct medical coding and SAE/AE reconciliation.
- Liaise with third-party vendors for data deliverables.
- Identify and troubleshoot project issues based on performance metrics.
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