TMF Associate

Job Overview

As a TMF Associate at Alimentiv, you will oversee the management of Trial Master File (TMF) content and related processes throughout the lifecycle of clinical studies, from initial setup to eventual transfer or archiving. This role requires collaboration with study teams during regular file reviews and audits to resolve TMF-related issues. You will be responsible for organizing and controlling access to the electronic file repository in accordance with established structures and frameworks. Working effectively within a cross-functional team, you will actively communicate department and company goals, fostering a positive and professional work environment.

Key Responsibilities

• Act as the main contact for TMF management of assigned studies.
• Maintain TMF completeness and ensure all documents are filed promptly, keeping the TMF inspection-ready throughout the study duration.
• Collaborate with the Team Lead to develop study-specific TMF documents such as File Index, Expected Document Lists, and TMF Management Plans aligned with study protocols.
• Create and update study-specific work instructions when necessary.
• Organize a quality control schedule and periodically inventory study TMFs to verify completeness.
• Identify and communicate missing or out-of-scope documents to study teams, escalating issues as appropriate.
• Reconcile expected document lists in relation to study milestones and events.
• Handle TMF help desk inquiries, including ticket prioritization and triage.
• Provide training on TMF processes to internal and external stakeholders as required.
• Process and review documents ensuring adherence to scanning guidelines and ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate).
• Efficiently file and retrieve TMF documents in a timely manner.
• Complete routine administrative duties, such as timesheets and performance metrics reporting.
• Contribute to team discussions, decision-making, and knowledge sharing during meetings and smaller group sessions.
• Support development and maintenance of internal record-management systems.
• Mentor and train junior staff members.
• Identify opportunities to enhance department quality systems and propose process improvements.

Candidate Qualifications

• Possess a college diploma or degree with 1-3 years of relevant experience or ongoing training related to TMF management.
• Have familiarity with TMF organization, implementation, archival processes, and regulatory guidelines to ensure document integrity and quality.
• Understand and apply ALCOA principles in TMF oversight.
• Demonstrate strong time management and problem-solving skills, proactively identifying and resolving challenges.
• Show proficiency in computer skills, especially Microsoft Office suite, with potential for further development.

Work Environment and Additional Information

• Primarily home-based work, with occasional need to visit the office.
• Accommodations for candidates with disabilities are available upon request throughout the recruitment and selection process; requests can be sent to recruitment@alimentiv.com.
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• AI Usage Disclosure: Alimentiv may utilize AI tools during candidate screening and assessment phases to support decision-making, but final hiring decisions are made by humans. Candidates may inquire about data processing upon request.