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Associate Director, TMF Operations and Clinical Operations Analytics
The Associate Director of Strategic TMF Operations and Clinical Operations Analytics is a vital member of the Clinical Operations Leadership Team within the Clinical Science and Medical Affairs organization. This role provides strategic leadership and oversight of Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality. The ideal candidate will possess TMF system and process expertise, exceptional vendor oversight, and a strong foundation in inspection readiness and support.
Beyond TMF responsibilities, this position oversees Clinical Operations reporting, metrics, KPIs, and analytics. The role involves collaborating with senior leaders and key stakeholders to establish, manage, and generate reports and analytics that support performance measurement, delivery optimization, and continuous improvement.
KEY RESPONSIBILITIES
TMF Operations: Accountable for the company's Trial Master File support model, processes, and systems
• Responsible for oversight and management of TMF vendors and associated processes for the TMF
• Primary point of contact related to TMF processes and systems and study specific TMF support, as appropriate.
• Develop and oversee global TMF-related standards, standard operating procedures (SOPs) and corresponding controlled documents that are in line with relevant regulations (e.g., ICH-GCP, and regulatory requirements such as EMA and MHRA) and industry best practices (e.g., CDISC Trial Master File Reference Model).
• Provide expertise and strong leadership to ensure inspection readiness and facilitate seamless support of audits and regulatory inspections.
• Review and provide expert TMF operations input into clinical documents, particularly study plans.
• Develop, generate, analyse, and present to leadership standard TMF metrics/KPIs to demonstrate TMF health.
• Lead the continuous evolution, implementation, and oversight of TMF support model.
• Provide operational leadership to TMF vendor budget negotiations and management of TMF operations spend.
• Lead and manage the relationship with TMF-related vendors, ensuring appropriate contract scope, budgets, vendor performance and issue resolution.
• Serve as TMF Operations functional area representative for the implementation of any systems or processes that would interface/integrate with TMF (e.g., CTMS, EDMS, ISF, CDMS/EDC).
• Lead governance committee with TMF Vendors
Clinical Operations Reporting and Analytics: Provides technical expertise and leadership to develop and execute Clinical Operations reporting and analytics strategies and initiatives that align with organizational business objectives.
• Create and generate sophisticated reporting, metrics/KPIs and other analytics that can be used to measure performance, compliance, and effectiveness.
• Lead interpretation of metrics and analytics to ensure accuracy, aligned stakeholder interpretation, and trends.
• Communicate performance metrics and KPIs to study teams, functional leadership, and senior management, identifying issues, trends, and opportunities.
• Ensure that portfolio of metrics, reporting and analytics solutions are fit for purpose at the company and are strategically aligned, accurate, scalable, and managed regarding functionality, utilization, and budget.
• Drive ongoing assessment of systems that support analytics and reporting to manage risks and gaps.
• Provides business oversight across all involved systems to ensure ongoing alignment and proper mapping of data in support of metrics/KPIs and Clinical Operations reporting.
SUPERVISORY RESPONSIBILITY
This position includes staff oversight and may include line manager responsibilities.
• Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the TMF portfolio and achieve department objectives.
• Responsible for ensuring appropriate operational training for staff members.
• Identification of high-performance team members and working on team development
Experience & Knowledge
Essential
• Advanced understanding of ICH-GCP, and regulatory requirements as they apply to the Trial Master File
• Previous experience in document management and electronic TMF systems (e.g., Veeva Vault, Wingspan, Trial Interactive, Documentum, etc.)
• Extensive experience with Veeva Vault and the suite of Veeva applications is strongly preferred.
• Capable of developing, executing, and assessing strategies to enhance processes and set direction in the TMF and Clinical Systems domain.
• Proficient in identifying, understanding, and mitigating risks, while ensuring effective communication of these risks to clinical leadership.
• Skilled in negotiating and influencing to address high-impact challenges within the TMF and Clinical Systems area.
• Previous experience actively supporting audits and regulatory inspections.
• Advanced experience in creating, generating, and analysing operational clinical trial metrics.
• Extensive experience in oversight and management of vendors
• Highly experienced in business ownership of reporting tools used to compile standard clinical trial metrics as well as generate ad-hoc reporting.
• Advanced end-to-end understanding of clinical trial phases involved in drug development and corresponding document requirements.
• Demonstrates strong leadership and project management abilities, with flexibility and agility in a multi-functional, global matrix environment.
• Ability to work independently with minimal supervision and within global, cross-functional team matrices.
• Extensive experience in oversight and management of vendors
• Experience in managing people and/or contracted resources.
• Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model)
• Excellent written and oral communication skills and strong interpersonal skills
• Possesses excellent time management and organization skills.
• A commitment to producing high-quality work with an attention to detail.
• Demonstrated ability to problem solve and use clear judgement in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.
Desirable
• Experience implementing and managing a wide range of clinical systems such as CTMS, IRT/RTSM and eCOA/ePRO is highly desirable.
• Experience with data management and biostatistical systems preferred.
• Experience in developing implementing inspection readiness processes and tools.
• Prior experience with Veeva Vault eTMF and/or other Veeva products is highly desirable.
• Additional knowledge of and experience with regulatory requirements (BLA/MAA submissions) and quality systems preferred.
Education & qualifications
• BA or Bachelor of Science, in science related field (biological science, medical, pharmacy or other health related discipline), or equivalent clinical research (or related) experience.
• Advanced degree preferred.
• At least 10 years relevant clinical research (or related) experience in a biotechnology/ pharmaceutical industry and/or clinical research organization in Clinical Operations and/or a focus on Clinical Systems and/or Trial Master File/Clinical Document Management.
• Demonstrated computer skills; proven functional knowledge of Microsoft packages (such as but not limited to Microsoft Word, PowerPoint, Project, Excel, SharePoint, Adobe Acrobat) and TMF and/or Document Management applications (e.g., eTMF, EDMS)