At a Glance
- Tasks: Manage the Trial Master File and ensure it's inspection ready throughout the study lifecycle.
- Company: Join a dynamic team at Alimentiv, a leader in clinical research.
- Benefits: Enjoy flexible home-based work with occasional office visits and supportive company culture.
- Other info: Opportunities for mentorship and professional growth in a supportive atmosphere.
- Why this job: Make a real impact in clinical trials while developing your skills in a collaborative 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 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 home-based working arrangements, opportunities for mentorship, and a commitment to employee development, all while contributing to meaningful projects in the clinical research field.
StudySmarter Expert Advice🤫
We think this is how you could land TMF Associate
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry and let them know you're on the hunt for a TMF Associate role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your TMF knowledge. Familiarise yourself with the latest regulations and best practices. Show them you’re not just a candidate, but someone who’s genuinely passionate about TMF management.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining our team and ready to dive into the TMF world with us.
We think you need these skills to ace TMF Associate
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the TMF Associate role. Highlight your relevant experience with Trial Master Files and any specific skills that align with the job description. We want to see how you fit into our team!
Showcase Your Organisational Skills:Since this role involves managing TMF content, it's crucial to demonstrate your organisational abilities. Share examples of how you've successfully managed documents or projects in the past. We love a good story about keeping things in order!
Be Proactive in Your Communication:In your application, reflect on how you communicate with stakeholders. Mention any experiences where you fostered a positive working atmosphere or resolved issues effectively. We value teamwork and a professional attitude here at StudySmarter!
Apply Through Our Website:Don’t forget to submit your application through our official website! It’s the best way for us to receive your details and ensures you’re considered for the TMF Associate position. We can’t wait to hear from you!
How to prepare for a job interview at Alimentiv
✨Know Your TMF Inside Out
Make sure you have a solid understanding of the Trial Master File (TMF) processes and regulations. Brush up on ALCOA principles and be ready to discuss how you would ensure the TMF is complete and 'inspection ready' throughout the study lifecycle.
✨Showcase Your Organisational Skills
Since this role involves managing a controlled electronic file repository, highlight your organisational skills. Be prepared to share examples of how you've maintained quality control schedules or performed periodic inventories in previous roles.
✨Communicate Effectively
This position requires interaction with various stakeholders, so practice your communication skills. Think of ways to demonstrate how you've fostered a positive working atmosphere in past experiences, especially when addressing findings during audits or reviews.
✨Be Proactive and Solution-Oriented
Employers love candidates who take initiative. Prepare to discuss specific challenges you've faced in previous roles and how you identified solutions. This will show that you can think on your feet and contribute positively to a cross-functional team.
