Trial Master File Manager

Welcome to Sanofi, a global biopharmaceutical company dedicated to improving lives through innovative medicines. We are currently seeking a Trial Master File Manager to join our team in ensuring the timely and accurate management of clinical trial documentation. In this role, you will play a crucial part in supporting our mission to bring new treatments to patients in need. The ideal candidate will possess strong organizational skills, attention to detail, and a passion for maintaining the highest standards of compliance. If you are looking for a challenging and rewarding opportunity in the pharmaceutical industry, we encourage you to apply for this role.

1. Manage and maintain the Trial Master File (TMF) for all clinical trials in compliance with regulatory requirements, company policies, and procedures.
2. Oversee the collection, review, and tracking of all essential documents and records related to clinical trials.
3. Ensure timely and accurate filing of all clinical trial documentation, including but not limited to, study protocols, informed consent forms, investigator brochures, and regulatory submissions.
4. Collaborate with cross-functional teams to ensure the completeness and accuracy of TMF content.
5. Develop and implement processes and procedures to enhance TMF management and compliance.
6. Regularly review and reconcile TMF content to ensure completeness and accuracy.
7. Provide guidance and support to study teams on TMF requirements and best practices.
8. Conduct TMF audits and inspections and assist with corrective and preventive actions.
9. Maintain up-to-date knowledge of regulatory requirements and industry standards related to TMF management.
10. Participate in the development and maintenance of electronic TMF systems.
11. Train and mentor new TMF team members.
12. Collaborate with external vendors and partners to ensure timely and accurate exchange of TMF documents.
13. Prepare and present TMF metrics and status reports to management.
14. Act as a point of contact for TMF-related queries and requests.
15. Ensure confidentiality and security of all TMF documents and records.
16. Continuously monitor and improve TMF processes and systems.
17. Participate in cross-functional initiatives to improve clinical trial processes and compliance.
18. Act as a subject matter expert on TMF-related topics and provide training and guidance to internal stakeholders.
19. Adhere to all company policies, procedures, and ethical standards.
20. Perform other duties as assigned by management.

According to JobzMall, the average salary range for a Trial Master File Manager in Budapest, Hungary is between 4,000 and 7,000 Hungarian Forints (HUF) per month, which is equivalent to approximately $14 to $25 USD per hour. This may vary depending on the specific company, level of experience, and additional skills or qualifications.

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.