TMF Associate

Job summary

The TMF Associate is responsible for managing Trial Master File content throughout the study lifecycle to ensure it remains complete and inspection-ready. They will collaborate with cross-functional teams to maintain file integrity, perform quality control, and provide training to stakeholders.

Job details

Job Title: TMF Associate Employment Type: Full time, Permanent Job Reports To: Manager, TMF Operations Department/Unit Name: TMF Operations Job Summary: Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set up to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to the TMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access management framework. Work proactively and successfully within a cross-functional team. Communicate and promote department and company goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude. Time allocated may be adjusted based on need. Positions Available: 2; Note this position is cross-listed in multiple countries. \n Service Delivery Serve as the primary TMF contact for assigned studies. Ensure TMF is complete and “inspection ready” throughout study lifecycle and documents are filed contemporaneously. Work with Team Lead to create study specific TMF management and oversight documents (e.g., File Index, Expected Document Lists and TMF Management Plan) in alignment with study. Develop and maintain study-specific work instructions, as needed. Utilize organization skills to maintain a quality control schedule and perform periodic inventories of study TMF to ensure completeness. Review and communicate out-of-scope and/or incomplete documents to study teams; escalating as needed. Reconcile expected document lists based on study events and milestones. Prioritize and resolve TMF help desk tickets; may include triaging activities. Provide study specific TMF training to internal and/or external stakeholders, as needed. Process and review documents, following applicable scanning and best practices and best practices, and applying ALCOA principles appropriately. File and retrieve TMF documents in a timely manner. Department Support Complete routine administrative tasks in a timely manner (e.g., timesheets, metrics). Participate in discussions, decisions and sharing of knowledge in department meetings, periodic presentations, and smaller working groups. Seek opportunities to assist in the development, implementation and maintenance of internal systems (e.g., databases used to manage records). Provide mentorship and training to junior level staff. Propose suggestions and work on the development and maintenance of department quality system documents to improve efficiencies. Qualifications The successful candidate will possess a college diploma/degree and 1-3 years of relative related experience or on going training. They will have an understanding of TMF organization, implementation, and archival including relevant regulations and guidance to assure quality and integrity of TMFs. Have the ability to incorporate the principles of ALCOA in relation to TMF oversight. Utilize skills in time management and problem-solving. Identify challenges and problems and take the initiative to identify solutions. Demonstrated computer literacy, proven functional knowledge of Microsoft packages and potential to develop. Working Conditions - Home based, with the ability to go into office occasionally if needed. *Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com Warning PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report. \n

What you’ll do

The TMF Associate is responsible for managing Trial Master File content throughout the study lifecycle to ensure it remains complete and inspection-ready. They will collaborate with cross-functional teams to maintain file integrity, perform quality control, and provide training to stakeholders.

Requirements

Candidates must possess a college diploma or degree and 1-3 years of relevant experience in TMF organization and regulatory guidance. Proficiency in Microsoft Office and a strong understanding of ALCOA principles are required for this role.

Listed skills

• Time management · Preferred
• Problem solving · Preferred
• Training · Preferred
• Regulatory Compliance · Preferred
• record keeping · Preferred
• Quality Control · Preferred
• Communication · Preferred
• Microsoft Office · Preferred
• Process Improvement · Preferred
• data management · Preferred
• Stakeholder Management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Trial Master File management
• Document control
• Quality control
• ALCOA principles
• Regulatory compliance
• Time management
• Problem-solving
• Microsoft Office
• Stakeholder management
• Training
• Data management
• Audit support
• Record keeping
• Process improvement
• Communication
• Functional Knowledge
• Organizational Skills
• Administrative Functions
• Quality Management Systems
• Auditing
• Management
• Computer Literacy
• Help Desk Support
• Problem Solving
• Mentorship
• Milestones (Project Management)
• Operations
• Presentations
• Phishing
• Time Management
• Team Leadership
• Trial Master File
• Quality Control
• File Structure

Job areas

• Healthcare
• Science & Research
• Administrative
• TMF Specialist
• Document Control / Management Specialist
• Filing and Copying Clerks
• Document Management Specialists
• Computer Occupations, All Other

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