TMF Manager at Sanofi Aventis US LLC

City of Brisbane, Queensland, Australia -

Full Time

Start Date

Immediate

Expiry Date

17 Apr, 26

Salary

0.0

Posted On

17 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Documentation, Trial Master File Management, ICH-GCP Standards, Project Management, Organizational Skills, Collaboration, EDMS/eTMF Systems, Microsoft Office Suite, Communication Skills, Detail Orientation, Mentoring, Training, Digital Initiatives, Process Improvements, Compliance, Strategic Thinking

Industry

Pharmaceutical Manufacturing

Description

Job Title: Trial Master File (TMF) Manager Location: Queensland/hybrid (Brisbane/Gold Coast) Job Type: Permanent, Full time Join our Translational Science Hub (TSH) TEAM! Sanofi is a leading global healthcare company going through a significant transformation. We are on a journey to attract and develop top diverse talent to join our mission to bring innovation to more and more patients around the world About the role We are seeking an experienced Trial Master File Manager to join our Vaccine Clinical Documentation Platform. As a key member of the Clinical Team, you will play a pivotal role in overseeing and managing the Trial Master File (TMF) for assigned clinical trials, ensuring compliance with ICH-GCP standards and internal processes. This position is ideal for someone with strong clinical documentation expertise, exceptional organisational skills, and the ability to collaborate effectively across cross-functional teams. Key Responsibilities Set up, oversee, and lock clinical TMFs for assigned studies. Ensure the quality Clinical Department Trial Master Files are ready for inspection at any time. Lead TMF kick-off meetings with clinical teams and CROs. Write, maintain, and update TMF Plans throughout the study lifecycle. Monitor TMF quality and completeness, providing metrics, reports, and remediation plans when needed. Provide support, guidance, and oversight to Associate TMF Managers and Clinical Documentation Administrators. Act as the main point of contact for TMF contributors, providing expertise on TMF processes and eTMF/EDMS systems. Coordinate TMF readiness for audits and inspections, including timely document provision and compliance checks. Lead TMF reviews, corrective action planning, and secure final archiving of TMFs. Train and mentor newcomers on TMF processes and tools. Contribute to digital initiatives and process improvements within TMF management. About You You will bring strong experience in clinical documentation and trial master file management, with the ability to balance detail and strategy while driving compliance and efficiency. Qualifications & Experience Bachelor’s degree (life sciences or related field preferred). Experience in TMF management or transversal clinical project management. Deep knowledge of ICH-GCP, TMF regulations, and clinical development processes. Strong project management and organisational skills, with a rigorous eye for detail. Excellent written and verbal communication skills. Proficient with EDMS/eTMF systems and Microsoft Office Suite. Strong collaboration and influencing skills. Entrepreneurial mindset and openness to innovation. Strategic thinking and customer focus. Ability to train, mentor, and inspire others. Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The TMF Manager will oversee and manage the Trial Master File for assigned clinical trials, ensuring compliance with ICH-GCP standards. Responsibilities include setting up TMFs, leading meetings, monitoring quality, and coordinating audits.