At a Glance
- Tasks: Manage the Trial Master File and collaborate with study teams throughout the study lifecycle.
- Company: Join a dynamic company focused on innovative clinical research.
- Benefits: Enjoy flexible working conditions, competitive salary, and opportunities for professional growth.
- Other info: Work from home with occasional office visits; inclusive hiring practices.
- Why this job: Make a real impact in clinical trials while developing your skills in a supportive environment.
- Qualifications: College diploma/degree and 1-3 years of relevant experience or ongoing training required.
The predicted salary is between 30000 - 40000 £ per year.
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 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.
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 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 ongoing 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.
TMF Associate in London employer: Alimentiv
At Alimentiv, we pride ourselves on being an exceptional employer, offering a supportive work culture that values collaboration and professional growth. As a TMF Associate, you will benefit from flexible working arrangements, opportunities for mentorship, and a commitment to employee development, all while contributing to meaningful projects in a dynamic environment. Our inclusive approach ensures that every team member feels valued and empowered to make a difference.
StudySmarter Expert Advice🤫
We think this is how you could land TMF Associate in London
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Alimentiv.
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We think you need these skills to ace TMF Associate in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Alimentiv!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Alimentiv that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Alimentiv!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Alimentiv, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Alimentiv
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Alimentiv that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Alimentiv’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
