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TMF Lead II (LATAM)

3 hours, 48 minutes ago
Mexico, Brazil
Full-time
Mid Level
Program Manager
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 88

Description

  • Ensure timely, high-quality TMF document review, processing, periodic quality review, setup, maintenance, finalization, and archival for assigned studies.
  • Create and execute the study TMF Plan and project TMF Document Index, and communicate updates to the project team.
  • File TMF documentation such as the TMF Plan, TMF Index, and periodic quality review records.
  • Attend project kick-off meetings, internal and external meetings, and ad hoc meetings to report TMF status, gaps, and escalations.
  • Collaborate with Project Managers and Functional Leads to keep TMF documentation timely, complete, and inspection-ready.
  • Identify TMF risks, document them appropriately, and implement mitigation actions.
  • Monitor TMF health and metrics, report non-compliances and issues, and escalate concerns to internal leadership as needed.
  • Support audits, inspections, and related interviews, and help drive resolution of findings.
  • Ensure periodic quality reviews and document processing are carried out by the appropriate specialists.
  • Manage study close-out activities, including final document submission, outstanding queries, vendor eTMF export, sponsor transfer, and receipt acknowledgment.
  • Support work in the sponsor eTMF system when needed.
  • Monitor and report out-of-scope records management activities to the TMF manager.

Requirements

  • Bachelor’s degree or international equivalent.
  • Minimum of 3 years of related experience, or an equivalent combination of education, training, and experience.
  • Professional working proficiency in English.
  • Established fluency with Microsoft Office programs, including Outlook, Word, Excel, and PowerPoint.
  • Experience with eTMF systems and vendors.
  • Working knowledge of FDA and ICH/GCP regulations and guidelines.
  • Ability to learn and retain knowledge of ICH-GCP, Precision SOPs, and relevant regulatory guidance.
  • Strong interpersonal skills.
  • Ability to identify issues and escalate them appropriately and effectively.
  • Strong organizational skills, time management, workload coordination, and ability to meet deadlines.
  • Detail-oriented, self-motivated, and able to work independently and in a team environment.
  • Professional communication skills, both verbal and written.

Interested in this position?

Apply directly on the company website

Apply Now

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