Associate Director, TMF Operations, Clinical Operations Analytics

TGS

Associate Director of TMF Operations overseeing Trial Master File and analytics in clinical operations. Collaborating with leadership for performance measurement and continuous improvement strategies.

Posted 4/20/2026contractPhiladelphia • Pennsylvania • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud PlatformVault

About the role

Key responsibilities & impact

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
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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

TMF managementdocument managementclinical trial metricsrisk mitigationreporting and analyticsaudit supportvendor managementprocess enhancementclinical trial phasesproject management

Soft Skills

leadershipcommunicationinterpersonal skillstime managementorganizationproblem solvingflexibilityagilityindependenceinfluencing