TMF Lead II
New
P
Precision Medicine GroupClinical Trial Services
Mexico, Brazil, Argentina, Colombia, Chile, and PeruFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- A minimum of 3 years of related experience
- Required Skills
- GCPMicrosoft Office
Requirements
- Bachelor’s degree or international equivalent.
- Minimum 3 years of related experience.
- Professional working proficiency in English.
- Experience with eTMF systems and vendors.
- Working knowledge of FDA & ICH/GCP regulations and guidelines.
- Fluency in Microsoft Office suite (Outlook, Word, Excel, PowerPoint).
- Strong interpersonal and organizational skills.
- Ability to identify and escalate issues effectively.
- Strong time management and ability to coordinate workload to meet deadlines.
- Self-motivated and detail-oriented.
Responsibilities
- Ensure timely and high-quality TMF document review, processing, periodic quality review, set up, maintenance, and archiving.
- Create and execute the study TMF Plan and project TMF Document Index.
- Manage project team expectations and communication regarding TMF plan/index updates.
- Engage with Project Managers and Functional Leads to ensure timely, inspection-ready documentation.
- Identify, document, and mitigate TMF risks.
- Monitor TMF health and metrics, escalating non-compliances and potential issues.
- Support audits and inspections, including participation in interviews.
- Ensure periodic quality reviews are performed and documented by the team.
- Manage study close-out activities, including final document submission and sponsor transfer.
- Manage projects within the Sponsor eTMF system where required.
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