TMF Associate

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Alimentiv

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

⚕️ Healthcare Insurance

🔬 Science

💊 Pharmaceuticals

Healthcare Insurance • Science • Pharmaceuticals

Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.

📋 Description

• 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]