Associate Director, Clinical Records Management & SOP Development

Summary

Join Generate:Biomedicines, a leading therapeutics company, as an Associate Director of TMF and Clinical Records Management and SOP Development. Lead the strategic direction, operational oversight, and quality governance of the Trial Master File (TMF) process across clinical development programs. Ensure compliance with regulations (ICH-GCP, 21 CFR Part 11), company SOPs, and industry best practices. Serve as the subject matter expert for all TMF-related activities, guiding internal teams and CROs. Oversee the eTMF system and related processes, maintaining key performance indicators (KPIs). Lead the creation and continuous improvement of Clinical Operations Standard Operating Procedures (SOPs). This role offers the opportunity to contribute significantly to the development of innovative therapies and make a real impact on patient lives.

Requirements

• 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 tasks to meet deadlines
• Effective leadership, organization, and interpersonal skills
• Strong working knowledge of clinical study documentation
• Proficiency in Veeva Vault eTMF and Microsoft Office Suite
• Extensive experience working with eTMF systems and CRO oversight
• Bachelor’s degree required; life sciences or related field preferred

Responsibilities

• Implement and maintain the eTMF System
• Ensure the eTMF System remains in a validated state through Release Cycles and configuration changes as required
• Implement and manage configuration changes to align with business needs and optimize workflows, collaborating with eTMF System counterpart as needed
• 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
• 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

Preferred Qualifications

• Experience in respiratory, immunology, or rare disease trials
• Familiarity with IND submissions and global study execution
• Knowledge of clinical systems (e.g., EDC, eTMF, CTMS)

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package