Job description
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.
Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.
The Associate Director, TMF Operations Manager, has primary accountability for the oversight and management of the TMF across all trials in Early and Late Phase within the organization. The Associate Director is accountable for ensuring integrity and compliance for filing all clinical trial data. This role is responsible for TMF management and ensuring compliance with TMF procedures, including SOPS, work instructions and templates. The Associate Director is responsible for overseeing the quality and accuracy of TMF documentation, according to GCP and regulatory requirements and for preparing TMFs for audits and regulatory inspections, meeting quality and timeline metrics. This role will also be accountable for vendor management as it pertains to all TMF required activities, including providing training and support to vendor teams on TMF related topics. The TMF Operations Manager will not only be responsible for the internal TMF system at MindMed but for process improvement initiatives as well, identifying and implementing improvements to TMF processes and systems.
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.
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)
- Experience working with CROs, their SOPs and other vendors
