Associate Director, Clinical Records Management & SOP Development

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role: 

The Associate Director of TMF is responsible for the strategic leadership, operational oversight, and quality governance of the Trial Master File (TMF) process across clinical development programs. This individual ensures that TMF systems, processes, and documentation comply with applicable regulations (ICH-GCP, 21 CFR Part 11), company SOPs, and industry best practices (e.g., DIA TMF Reference Model).

They will serve as the subject matter expert (SME) for all TMF-related activities, guiding internal teams and CROs to maintain inspection-ready TMFs at all times.

The Associate Director of Clinical Records Management and SOP Development is an agile and proactive individual who will be responsible for the leadership and management of the Trial Master File (TMF) ensuring compliance with regulations throughout the lifecycle of a study from study start through archival. This individual will oversee the eTMF system and all related processes, ensuring an inspection-ready state by maintaining Key Performance Indicators (KPIs) such as Quality, Completeness, and Timeliness.

Additionally, the role will be responsible for leading the creation and continuous improvement of Clinical Operations Standard Operating Procedures (SOPs) to ensure consistency, compliance, and operational efficiency.

Here's how you'll contribute:

TMF

· Implement and maintain the eTMF System

o Ensure the eTMF System remains in a validated state through Release Cycles and configuration changes as required

o Implement and manage configuration changes to align with business needs and optimize workflows, collaborating with eTMF System counterpart as needed

o Manage user access and ensure data in the eTMF is up-to-date and accurate based on study needs

· Develop, implement, and maintain all TMF related processes inclusive of SOPs, Forms, Templates, and Work Instructions

· Own governance of the TMF Structure

· Manage all TMF related processes at their required timepoints (ie, TMF Periodic QC Reviews, Completeness Checks, and Oversight QC Reviews)

· Develop and provide training materials for applicable processes to relevant internal and external stakeholders

· Develop and maintain TMF Metrics and Reports to manage KPIs inclusive of Quality, Completeness, and Timeliness

· Analyze TMF Metrics and Reports to identify areas for improvement and implement solutions as needed

· Oversee the quality control of TMF documents, ensuring documents are being filed contemporaneously, and properly reviewed and approved in a timely manner

· Collaborate with cross functional areas inclusive of external stakeholders for functional area specific requirements

· Manage oversight of CRO TMFs throughout the duration of the trial and manage TMF migrations as needed

· Manage the migration, transfer, archival of the TMF as needed

· Participate in audits and inspections

· Manages the TMF budget

SOPs

· Lead the development, creation, and implementation of SOPs

· Collaborate cross functionally as needed to standardize best practices and ensure SOPs align with regulatory requirements and organizational goals

The Ideal Candidate will have:

· BA/BS required

· 7+ years of relevant TMF experience, SOP development, and/or operations leadership

· In depth knowledge of relevant regulations and GCP. Deep understanding of ICH-GCP, 21 CFR Part 11, TMF Reference Model, and clinical trial lifecycle.

· Proficient knowledge of CDISC Reference Model

· Ability to handle multiple