The Opportunity:

As the Senior Manager, Trial Master File, you will be responsible for working across clinical study teams implementing and executing eTMF strategy, governance, and processes for TMF documentation across the development portfolio. You will also have the opportunity to build and develop a fit-for-purpose eTMF team who can manage filing and maintenance activities for clinical studies during the study start-up, maintenance and close-out periods. To be successful, you will be detail-oriented, with a flexible and solution-oriented outlook and the ability to support team members within Relay Therapeutics and with our CRO partners.

 Your Role:

  • You will lead and provide oversight of the eTMF group
  • You will proactively identify resourcing needs, ensuring key roles are hired and onboarded to ensure eTMFs meet regulatory requirements and are inspection ready
  • You will create and implement governance structure for eTMF activities by defining and analyzing metrics that are needed to assess eTMF completeness, timeliness, and quality.
  • You will ensure reporting is periodically communicated to key stakeholders and initiate corrective actions for quality events/low performing metrics.
  • You will participate on the Joint Operating Committee for key external partners and oversee eTMF metrics as applicable.
  • You will build and maintain strong partnership with key stakeholders and leadership to ensure cross-functional eTMF engagement.
  • You will partner with CROs/Vendors to ensure responsibilities around eTMF are clearly defined and executed.
  • You will oversee eTMF study creation, maintenance, and archival, ensuring all activities are performed in accordance Relay’s Standard Operating Procedures (SOPs), ICH-GCP Guidelines, EMA, FDA, and other health authority requirements.
  • You will serve as TMF Archivist for Relay Therapeutics.
  • You will anticipate business needs to assess current state of eTMF and identify opportunities for process improvement, ensuring industry best practice is implemented.
  • You will oversee eTMF Plans, Study-specific TMF Indexes, and QC approach across all studies.
  • You will be the content owner for all eTMF SOPs, Work Instructions, and other associated documents.
  • You will partner with IT on eTMF system release management, change control, system optimization, and eTMF migrations.
  • You will serve as eTMF representative for all health authority inspections and audits and ensure inspectors have appropriate access to the eTMF prior to and during inspections.
  • You will lead and mentor junior team members to support their development and enable all deliverables.

Your Background:

  • You have 7-10 years industry experience in management and maintenance of TMF/eTMF.
  • You have working knowledge of ICH-GCP, FDA, and EMA regulations.
  • You have considerable knowledge of the CDISC TMF Reference Model
  • You have experience working in and administering Veeva Vault eTMF
  • You have experience with eTMF migrations.
  • You have previous experience establishing and managing CRO partnerships for eTMF activities.
  • You are a motivated self-starter who has demonstrated critical thinking skills.
  • You have excellent organizational skills with the ability to multi-task and prioritize effectively in an extremely fast-paced and dynamic environment.
  • You have outstanding verbal and written communication skills, allowing for an open and effective dialogue throughout the organization.
  • You have a strong work ethic, excellent problem-solving ability, and attention to detail and quality are critical to success.

#JO1

About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.  

Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us! 

 

 

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