Supervisor, Trial Master File

Shanghai, China   |   full time   |   Job ID: 9275 

The Manager TMF is a key role responsible for ensuring the completeness and accuracy of the TMF for all BioNTech-sponsored clinical trials including China standalone or China led APAC regional trials. This role is responsible for providing technical expertise in both paper and electronic TMF management, and for supporting inspection readiness goals in compliance with ICH/GCP guidelines, regulatory requirements, and internal policies.

Your main responsibilities are:

• Providing a framework to evaluate the overall health of the TMF, ensuring quality, completeness, and timeliness in the eTMF for all BNT-sponsored clinical trials, and collaborating with the BNT trial teams to achieve these goals.
• Monitors and identifies TMF trends, identifies risks to TMF health, and generates and delivers on TMF performance metrics. This role will work closely with cross-functional teams and CROs to ensure TMF deliverables are met in a timely and accurate manner.
• Deep understanding of industry standards and regulatory requirements related to TMF management and compliance, as well as the ability to 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.
• Supporting/ conducting TMF related inspection/ audit interviews based on inspection/ audit scope and ensuring the TMF is ready to be archived at the end of the trial.

What you have to offer:

• 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
• Relevant experience in clinical trials related roles (i.e., clinical operations and project management)
• Long-standing working experience in international context and cross functional project work. This means, independently, collaboratively, and pro-actively managing (improvement) projects and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines.
• The experience and ability to work effectively in a team environment and to balance multiple projects simultaneously.
• Extensive knowledge and ability to apply relevant applicable regulations, guidelines and industry bests practices related to TMF management. This includes knowledge of ALCOA+ standards, Good Documentation Practice (GDP), and International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) (E6), CRF Part 11 and other regulations and guidelines.
• Subject Matter Expert knowledge of clinical trial documentation, demonstrated understanding of the TMF Reference Model filing structure, clinical trial activities and related terminology.
• Must have ability to navigate eTMF systems, ideally Veeva Vault or other Electronic Document Management System.
• Strong computer skills, including proficiency in all common Microsoft Office applications and familiarity with clinical trial applications, including those used to manage and archive regulatory content. Smooth self-training of new software programs.
• Experience with TMF audits and inspections. This includes experience preparing for and participating in TMF audits and inspections, including facilitation of inspector access to TMF as required.

Your Benefits:

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.

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.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.