TMF Associate

Alimentiv; Warszawa; Hybrid; PLN 60,000 - 90,000; Full time

Benefits offered by this job

Home-based

Job summary

Alimentiv seeks a TMF Associate to manage Trial Master File content and related processes across the study lifecycle from setup to transfer/archiving. You will partner with study teams during file reviews and audits to address findings and ensure organized, accessible TMF documentation in the controlled electronic repository.

The position is full-time and permanent, home-based with occasional office visits, and involves collaboration within the TMF Operations team.

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

Responsibilities

• 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
• Complete routine administrative tasks in a timely manner and participate in department meetings and knowledge sharing
• Seek opportunities to assist in development and maintenance of internal systems and mentor junior staff

Skills

Time management

Problem solving

Microsoft Office

ALCOA principles

Education

College diploma/degree

Tools

Microsoft Office Suite

Job description

Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study setup to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to theTMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and accessmanagement framework. Work proactively and successfully within a cross-functional team. Communicate and promote department andcompany goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses aprofessional and helpful attitude. Time allocated may be adjusted based on need.

Positions Available: 2; Note this position is cross-listed in multiple countries.

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 setup to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to theTMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and accessmanagement framework. Work proactively and successfully within a cross-functional team. Communicate and promote department andcompany goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses aprofessional and helpful attitude. Time allocated may be adjusted based on need.

Positions Available: 2; Note this position is cross-listed in multiple countries.

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 [e-mail]

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.