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]
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