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Associate Director, Clinical Records Management & SOP Development at Jobgether. 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.. . Company Location: United States.