Associate Director, TMF Operations Manager

Summary

Join MindMed, a clinical-stage biopharmaceutical company, as an Associate Director, TMF Operations Manager. You will oversee and manage the Trial Master File (TMF) across all trials, ensuring integrity and compliance with regulatory requirements. Responsibilities include eTMF system management, vendor oversight, process improvement, and support for audits and inspections. You will collaborate with cross-functional teams, including Clinical Operations and Quality Assurance, to maintain inspection readiness. The ideal candidate possesses a BS degree in Life Sciences, 8+ years of clinical trial experience, and proficiency with various TMF systems. Travel up to 15-20% is required.

Requirements

• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• Minimum of 8 years clinical trial experience in the pharmaceutical industry or CRO
• Proficiency with clinical trial documentation and regulatory requirements
• Willingness and ability to travel up to 15-20% of the time, defined by business needs
• Strong organizational, communication and problem-solving skills
• Experience and expertise with a range of TMF systems (ie: Medidata, Trial Interactive, Veeva, etc)

Responsibilities

• Oversee, manage and drive to completion required daily eTMF system related activities
• Oversight of eTMF vendor(s) and related TMF setup, maintenance, and closeout processes; eTMF user support and training
• Engage cross functional and CRO stakeholders to ensure eTMF users are effectively utilizing the system as well as obtaining feedback and suggestions for user improvement to aid in delivering an inspection ready TMF
• Oversee and manage all study vendors to ensure compliance with TMF filing, both required study documents as well as correspondences meeting thresholds for TMF filing
• In collaboration with Clinical Operations, accountable for ensuring vendors are always staying inspection ready; identifying and mitigating risks, providing oversight and reporting metrics to stakeholders
• Ensure TMF completeness, quality, and inspection readiness across all studies
• Liaison between Clinical Operations and Quality Assurance (QA), support overall GCP compliance and inspection preparedness activities
• Identify and drive continuous Clinical Operations/TMF process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations
• Assist in the implementation of compliant procedures and operations to ensure a robust clinical trial documentation, following ALCOA++ principles to ultimately support inspection preparedness activities
• Support preparation and hosting of Health Authority Inspections (e.g. BIMO, MHRA, EMA) internally, at clinical sites, and at CROs, including follow-up efforts and responses to any observations
• Support internal and external audit programs, including the development of audit plans, priorities and schedules
• Partner cross functionally to enable transparency & escalation of inspection readiness needs, collaborating to address challenges and constraints, fostering a commitment to quality in clinical trial execution
• Collaborate cross functionally to develop and drive inspection preparedness activities that assure clinical trials are conducted and data collected in compliance with approved plans and/or protocols, SOPs/internal procedures, and regulatory
• Assure personnel, documentation (protocols, reports), processes and quality standards meet expectations for regulatory submissions, regulatory authority inspections, and compliance with applicable regulations and guidelines
• Develop and oversee appropriate Clinical Operations/TMF metrics and reporting on the state of compliance to senior management and teams
• Accountable to drive lessons learned initiatives at trial level during and after trial milestone completion; accountable for developing subsequent issue resolution and process improvements as required