Associate Director, Clinical Records Management & SOP Development

This position is posted by Jobgether on behalf of Generate Biomedicines. We are currently looking for an Associate Director, Clinical Records Management & SOP Development in United States.

As Associate Director, you will lead strategic oversight of clinical documentation systems and SOP development to ensure inspection-ready compliance and operational excellence across global clinical trials. This high-impact role requires a proactive leader with expertise in TMF systems, regulatory frameworks, and cross-functional collaboration. You will manage the full lifecycle of eTMF processes and documentation, while also driving the development and standardization of SOPs to optimize clinical operations. This is an opportunity to join a fast-growing, tech-driven biotech environment at the forefront of innovation in therapeutic development.

Accountabilities:

• Oversee the eTMF system across its lifecycle, ensuring continuous validation, timely updates, and alignment with study needs.
• Implement and manage configuration changes to enhance workflows and user experience.
• Own TMF governance, including structure management, SOPs, templates, forms, and process implementation.
• Lead periodic quality control reviews, completeness checks, and oversight audits to maintain inspection readiness.
• Analyze TMF KPIs (quality, completeness, timeliness) and develop strategies for process improvement.
• Collaborate with internal teams and CROs to ensure real-time, accurate filing and documentation oversight.
• Train internal and external stakeholders on TMF procedures and best practices.
• Manage TMF migration, transfer, and archival, ensuring compliance throughout.
• Lead SOP development, standardization, and updates in collaboration with clinical and regulatory teams.
• Support audit readiness, participate in inspections, and maintain TMF budget oversight.

• Bachelor’s degree required (life sciences or related field preferred).
• 7+ years of experience in TMF management, SOP development, and clinical operations.
• Strong understanding of ICH-GCP, 21 CFR Part 11, TMF Reference Model, and the clinical trial lifecycle.
• Demonstrated proficiency in Veeva Vault eTMF and Microsoft Office Suite.
• Skilled in handling multiple priorities in a dynamic environment with high attention to detail.
• Proven ability to lead cross-functional initiatives and engage stakeholders effectively.
• Familiarity with CDISC Reference Model and oversight of CROs.
• Excellent organizational, analytical, and communication skills.
• Experience in therapeutic areas such as respiratory, immunology, or rare disease is a plus.
• Knowledge of clinical systems (e.g., EDC, CTMS) and experience with IND submissions is advantageous.

• Competitive annual base salary: $160,000—$224,000 USD.
• Annual performance bonus and equity compensation.
• Comprehensive healthcare package (medical, dental, vision).
• Flexible working arrangements and generous PTO policy.
• Career growth opportunities in a mission-driven, tech-enabled biotech company.
• Inclusive culture that values diversity and collaboration.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role.
Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!

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