TMF Lead (India)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for TMF Lead to join our A-team (remote/hybrid*). As a TMF Lead at Allucent, you are responsible for coordinating the management of trial master files (TMF) for trials at Allucent. This position controls and monitors the activities of the trial team to create, maintain and return to the Sponsor an inspection ready TMF for all assigned studies.

In this role your key tasks will include:

• Collects trial specific requirements to ensure the correct set up of the TMF and creation of the study specific TMF plan.
• Works with TMF Specialists to ensure document metadata entry accurately reflects trial specific requirements and is entered in a consistent manner.
• Ensures that Essential Document Lists are regularly updated by the study team allowing the completeness of the TMF to be accurately assessed.
• Oversees TMF document flow in ensure that documents are uploaded within required timelines.
• Responsible for developing cross-functional relationships with internal and external stakeholders to ensure the successful management of the TMF.
• Provides regular status reports to project manager and sponsor regarding the status of the TMF.
• Conducts periodic quality re