Manager* Trial Master File
Location
Cambridge, MA | United States
Job description
Manager* Trial Master File
The Manager* TMF plays a critical role in ensuring the completeness and accuracy of the TMF for all BioNTech-sponsored clinical trials. This role is responsible for providing expert guidance in TMF management, driving a culture of compliance and quality that aligns with ICH/GCP guidelines, regulatory requirements, and internal policies.
Key Responsibilities:
- Provide a robust framework to evaluate the overall health of the TMF, ensuring quality, completeness, and timeliness in the TMF for all BNT-sponsored clinical trials, driving a culture of compliance and quality.
- Take ownership of TMF health by identifying risks and ensuring compliance with internal and regulatory requirements. Proactively generate, monitor, and analyze TMF performance metrics and trends, and collaborate with the trial team to ensure the completeness and accuracy of the TMF.
- Build collaborative relationships with trial and cross-functional teams as well CROs to ensure the timely and accurate delivery of TMF-related deliverables.
- Collaborate with and support the trial team in defining and maintaining expected study documents throughout the entire trial lifecycle, including ensuring appropriate maintenance of expected documents in the eTMF.
- Take ownership of TMF-related initiatives, driving a culture of excellence and success, and actively participating in improvement projects to identify and implement changes that enhance the efficiency, quality, and compliance of TMF-related processes.
- Play a critical role in ensuring compliance with internal and regulatory requirements by conducting or supporting inspection/audit interviews related to the TMF.
- Provide guidance and conduct trainings to educate team members, trial teams, and contributors about the tools, systems, and procedures related to TMF management and compliance, driving a culture of compliance and quality across the organization.
Qualifications, Professional Experience and Skills:
- University degree qualified or comparable professional education, preferably in medicine / science, paramedical science, computer science, business management or related degree or more than 5 years extensive experience in similar roles and proven track record.
• At least five (5) years of pharmaceutical industry or drug development experience
- At least 3 years TMF experience required, including experience in study start-up, maintenance, and closeout, and performing quality and completeness reviews.
- Long-standing working experience in international context and cross functional project work.
- Proven track record of driving effective TMF-related initiatives.
- Extensive knowledge and expertise in applicable regulations, guidelines, and industry best practices related to TMF management.
- Expertise in clinical trial documentation and TMF Reference Model filing structure and proficient in eTMF systems, ideally Veeva Vault or other Electronic Document Management Systems
- Strong communication and problem-solving skills with the ability to provide solutions.
- Ability to prioritize tasks and manage time effectively.
- Fluent in written and spoken English.
- Ability to exert a positive influence on others, persuade them to gain their support and foster a culture of collaboration and success.
- Demonstrate the ability to make decisions in a fast-paced environment, deliver on commitments, share knowledge, recognize other accomplishments, and collaborate with colleagues to meet goals and timelines.
- Commitment to driving a culture of compliance and quality.
Benefits for you
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
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This vacancy is to be hired at one of the following locations – Cambridge Erie Street, Cambridge, Cambridge Hamilton Street, Cambridge Sidney Street, Gaithersburg, London, Mainz Goldgrube . Apply now for your preferred job and location through our careers site .
*BioNTech does not differentiate on the basis of race, colour, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, veteran status, genetic information, or any other characteristic protected by applicable law. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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