Manager, Records Management
New
P
Precision for MedicineClinical Trial Services
We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and PeruFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- A minimum of 8 years of related experience, including a minimum of 2 years in a leadership capacity
- Required Skills
- Microsoft OfficeQuality AssuranceTeam managementProcess improvement
Requirements
- Bachelor’s degree or international equivalent.
- Minimum 8 years of related experience.
- Minimum 2 years of leadership experience.
- Professional working proficiency in English.
- Experience with eTMF systems and vendors.
- Track record of implementing process and standardization for clinical trials.
- Working knowledge of FDA & ICH/GCP regulations and guidelines.
- Fluency in Microsoft Office suite.
- Excellent organizational, time management, and problem-solving skills.
Responsibilities
- Oversee staff performing TMF-related activities including document quality review and TMF quality review.
- Perform review of the study TMF Plan and TMF Document Index.
- Monitor TMF metrics via system reports and identify process or performance challenges.
- Support audits and inspections.
- Perform weekly or biweekly 1:1 meetings for performance management.
- Identify staff development and training needs.
- Collaborate on drafting SOPs, Forms, and Work Instructions.
- Provide subject matter expertise to internal and external partners regarding TMF best practices.
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