TMF Lead II – LATAM

This is a fully remote position, open to applicants in Brazil, +1 more country.

📋 Description

• Assist project teams in ensuring the integrity of Trial Master Files (TMFs) in alignment with GCP, guidance documents, and Precision Standard Operating Procedures (SOPs).

• Conduct TMF document evaluation and processing, periodic quality assessments, setup, maintenance, finalization, and archiving of study TMFs.

• Develop and implement study TMF Plans and project TMF Document Indexes.

• Ensure study teams comprehend TMF expectations and convey any modifications to TMF Plans or Indexes.

• Organize TMF documentation, including TMF Plans, TMF Indexes, and documentation for Periodic Quality Reviews.

• Participate in and provide input during project kickoff, internal, external, and ad hoc meetings.

• Work collaboratively with Project Managers and Functional Leads to uphold inspection-ready TMFs.

• Recognize, document, and address TMF risks.

• Oversee and report on TMF health and metrics; raise awareness of non-compliances and potential issues.

• Detect trends, risks, and overall TMF status while proposing mitigation strategies.

• Assist with audits and inspections, resolving issues and participating in audit/inspection interviews.

• Ensure that Periodic Quality Reviews and document evaluations/processing are completed for assigned projects.

• Identify training requirements for TMF and provide or support team re-education efforts.

• Oversee study close-out tasks, including final submissions, query resolutions, eTMF exports, sponsor transfers, and acknowledgment of receipt.

• Manage projects within the Sponsor eTMF System as necessary.

• Monitor and report any potential out-of-scope Records Management activities to the TMF Manager.

⛳️ Requirements

• A Bachelor’s degree (or its international equivalent).

• At least 3 years of relevant experience, or a combination of education, professional training, and experience that is equivalent.

• Professional proficiency in English.

• Proven experience and proficiency in Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.

• Familiarity with eTMF systems and associated vendors.

• Understanding of FDA and ICH/GCP regulations and guidelines.

• Capability to identify issues and escalate them effectively and appropriately.

• Strong organizational skills, time management, workload coordination, and ability to meet deadlines.

• Working knowledge of ICH-GCP, applicable Precision SOPs, and regulatory guidance, or the ability to learn and retain this information.

• Ability to work independently and collaboratively within a team.

• Effective and professional verbal and written communication skills.

• Candidates must possess legal authorization to work in the employment country without the need for employer sponsorship.

🏝️ Benefits

• No benefits, perks, or compensation extras are specified in the posting.