Trial Master File (TMF) Manager - Vaccines

At Sanofi, we are dedicated to improving public health through the development and distribution of life-saving vaccines. As the Trial Master File (TMF) Manager for our vaccines division, you will play a crucial role in ensuring the success of our clinical trials. We are seeking a highly organized and detail-oriented individual with a strong background in TMF management and a passion for making a positive impact in the world. If you are looking for a fulfilling career in the pharmaceutical industry and have the necessary qualifications and skills, we would love to have you on our team.

1. Manage and maintain the Trial Master File (TMF) for all clinical trials conducted within the vaccines division of Sanofi.
2. Ensure that all required documents are collected and filed in a timely and accurate manner, in accordance with company and regulatory guidelines.
3. Oversee the organization and indexing of all TMF documents, ensuring easy access and retrieval of information for internal and external stakeholders.
4. Develop and maintain standard operating procedures (SOPs) for TMF management, ensuring compliance with industry standards and regulations.
5. Coordinate with cross-functional teams, including clinical operations, data management, and regulatory affairs, to ensure timely completion and submission of TMF documents.
6. Monitor TMF completeness and quality, identifying and addressing any deficiencies or discrepancies.
7. Provide training and support to team members and external partners on TMF requirements and processes.
8. Act as the primary point of contact for internal and external audits and inspections related to TMF documentation.
9. Stay up-to-date on industry trends and best practices related to TMF management, and implement changes as needed to optimize processes and ensure compliance.
10. Collaborate with the clinical team to identify potential risks and issues related to TMF documents, and develop mitigation strategies.
11. Maintain confidentiality and integrity of all TMF documents and information.
12. Communicate regularly with stakeholders and provide updates on TMF status, timelines, and any potential issues or concerns.
13. Participate in cross-functional meetings and contribute to the development of clinical trial protocols and other study-related documents.
14. Uphold Sanofi's commitment to public health and support the company's mission to improve and save lives through the development and distribution of life-saving vaccines.
15. Represent the company in a professional and ethical manner at all times.

According to JobzMall, the average salary range for a Trial Master File (TMF) Manager - Vaccines in Budapest, Hungary is approximately 6,000 to 10,000 Hungarian Forints (HUF) per month. This equates to approximately $20,000 to $33,000 USD per year. However, salaries may vary depending on the specific company and level of experience of the individual.

Sanofi SA is a French multinational pharmaceutical company headquartered in Paris, France, the world's fifth-largest by prescription sales. Building a More Equitable Future through Inclusive Clinical Trials · Rethinking the science of COPD · Grassroots Manufacturing Solutions for a Healthier Planet.