TMF Lead II – LATAM

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

📋 Description

• Assist project teams in upholding high-quality Trial Master Files in line with GCP, guidance documents, and Precision SOPs.

• Perform TMF document review and processing, periodic quality assessments, setup, maintenance, finalization, and archival tasks.

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

• Ensure that study teams are aware of TMF expectations and relay any changes to TMF Plans or Indexes.

• Organize TMF documentation, including TMF Plans, TMF Indexes, and Periodic Quality Review documents.

• Participate in and contribute to project kick-off meetings, internal and external meetings, as well as ad hoc meetings.

• Collaborate with Project Managers and Functional Leads to ensure the TMF is inspection-ready.

• Recognize, document, and mitigate TMF risks.

• Monitor and report on TMF health and metrics; escalate any non-compliances and potential issues.

• Identify trends, risks, and the overall status of the TMF, proposing mitigation strategies as necessary.

• Support audits and inspections, providing resolutions and participating in audit/inspection interviews.

• Ensure that Periodic Quality Reviews and document processing are completed by designated specialists.

• Determine TMF training needs and deliver or facilitate team re-education.

• Oversee study close-out activities, including final submissions, query resolution, eTMF export, sponsor transfer, and receipt acknowledgment.

• Manage projects within the Sponsor eTMF System when required.

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

⛳️ Requirements

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

• At least 3 years of relevant experience, or a combination of education, professional training, and experience that provides the necessary knowledge, skills, and abilities.

• Professional working proficiency in English.

• Proven experience and proficiency in Microsoft Office (Outlook, Word, Excel, and PowerPoint).

• Familiarity with eTMF systems and vendors.

• Working knowledge of FDA and ICH/GCP regulations and guidelines.

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

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

• Working knowledge of ICH-GCP, Precision SOPs, and relevant regulatory guidance, or the ability to receive training and retain this knowledge.

• Capability to work and plan independently as well as within a team environment.

• Professional verbal and written communication skills.

• Values and work ethic aligned with Precision Values and Company Principles.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Collaborative and inclusive work environment.

• Flexible working arrangements.