TMF Lead II
New
P
Precision for MedicineClinical Trial Services
Mexico, Brazil, Argentina, Colombia, Chile, and PeruFull-TimeLead
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 3 years
- Required Skills
- Project ManagementGCPMicrosoft Office
Requirements
- Bachelor’s degree or international equivalent.
- Minimum 3 years of related experience or equivalent combination of education/training.
- Professional working proficiency in English.
- Established experience with Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Experience with eTMF systems and vendors.
- Working knowledge of FDA & ICH/GCP regulations and guidelines.
- Solid interpersonal skills and effective issue escalation ability.
- Good organizational and time management skills.
- Strong self-motivation and detail-oriented.
- Ability to work independently and in a team environment.
Responsibilities
- Ensure TMF document review, processing, quality review, and archival are completed with high quality.
- Create and execute study TMF Plan and project TMF Document Index.
- Manage communication of TMF expectations and changes to the project team.
- Engage with Project Managers and Functional Leads to ensure timely documentation submission.
- Monitor and report on TMF health, metrics, and risks.
- Support audits and inspections.
- Provide TMF training and re-education to project teams.
- Manage close-out activities, including eTMF exports and sponsor transfers.
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