Alimentiv

Runs clinical trials for digestive disease treatments

TMF Associate

Clinical Research OperationsUpdated on Nov 10

Full-timeNo salary listed

About the Job

Requirements

A college diploma or degree and three years of related experience or ongoing training are required.
An understanding of Trial Master File organization, implementation, and archival, including relevant regulations and guidance, is required to assure TMF quality and integrity.
The ability to incorporate ALCOA principles in relation to TMF oversight is required.
Time-management, problem-solving, and computer-literacy skills are required, including functional knowledge of Microsoft packages and the potential to develop further.

Responsibilities

Manage Trial Master File content and associated processes throughout the study lifecycle, from study setup to transfer and archiving.
Partner with study teams during periodic file reviews and audits to address Trial Master File findings.
Manage access to and organization of the controlled electronic file repository in accordance with the defined file structure and access-management framework.
Serve as the primary Trial Master File contact for assigned studies.
Ensure the Trial Master File is complete and inspection-ready throughout the study lifecycle, with documents filed contemporaneously.
Work with the Team Lead to create study-specific Trial Master File management and oversight documents, including File Indexes, Expected Document Lists, and Trial Master File Management Plans, aligned with each study.
Develop and maintain study-specific work instructions as needed.
Maintain a quality-control schedule and perform periodic inventories of study Trial Master Files to ensure completeness.
Review and communicate out-of-scope or incomplete documents to study teams, escalating as needed.
Reconcile Expected Document Lists based on study events and milestones.
Prioritize and resolve Trial Master File help-desk tickets, including triage activities as needed.
Provide study-specific Trial Master File training to internal or external stakeholders as needed.
Process and review documents in accordance with applicable scanning practices and apply ALCOA principles appropriately.
File and retrieve Trial Master File documents in a timely manner.
Complete routine administrative tasks, such as timesheets and metrics, in a timely manner.
Participate in department discussions, decisions, knowledge-sharing, periodic presentations, and smaller working groups.
Assist with the development, implementation, and maintenance of internal systems, such as databases used to manage records.
Provide mentorship and training to junior-level staff.
Propose suggestions and contribute to the development and maintenance of department quality-system documents to improve efficiency.

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.

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 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 [email protected]

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.

About the Company

Alimentiv

Runs clinical trials for digestive disease treatments

Alimentiv runs clinical trials for pharmaceutical and biotechnology companies developing treatments for gastrointestinal diseases. Its contract research services cover study design, site monitoring and regulatory submissions, with medical imaging used to measure how patients respond to treatment. The company combines central image reading with tissue analysis and biomarker testing through sister laboratory AcelaBio. Sponsors pay for trial execution, scientific consulting and statistical services that support drug development from early studies through regulatory review. Founded in 1986, Alimentiv is headquartered in London, Ontario, and operates internationally.

Company size: 501-1,000
Company stage: Not listed
Total funding: Not listed
Headquarters: London, Canada
Founded: 1986

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