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About the role

  • TMF Associate responsible for managing Trial Master Files and supporting clinical studies. Collaborating with cross-functional teams and ensuring compliance during the study lifecycle.

Responsibilities

  • 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.

Requirements

  • 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.

Benefits

  • 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]

Job title

Job type

Full Time

Experience level

JuniorMid level

Salary

CA$50,000 - CA$84,000 per year

Degree requirement

Associate's Degree

Location requirements

RemoteCanada

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