Trial Master File and Registry Head
Trial Master File & Registry Head
This position can be based at any Pfizer Site or be Remote
Lead the operations and continuous innovation of TMF standards, practices and solutions at Pfizer as well as influence industry direction and policy. The Head of TMF and Registry leads defense related to TMF and Registry in withstanding most rigorous scrutiny in regulatory inspections and audits across Pfizer’s clinical trial portfolio.
- Revolutionize TMF management to predict and proactively manage quality enterprise repositories of clinical trial compliance documents and information
- Anticipate evolving regulatory expectations and position Pfizer to successfully establish quality and compliance of TMF and Registry across R&D Clinical Trial portfolio and across all Pfizer functional lines contributing to clinical trials (including GPD, WRD, Safety, Medicinal Sciences, Medical and Compliance)
- In partnership with Information Management peers and Pfizer Digital, lead the transformation of Trial Master File and Registry operations including end to end automation and use of latest machine learning and natural language processing capabilities
- Champion and defend Pfizer TMF directly to regulators and 3rd parties in GCP inspections as well as corporate audits annually across Pfizer
- Represent Pfizer in external industry forums and influence TNF standards and industry practices
- Provide direct support to regulatory inspections, including CAPA development and execution related to TMF
- Serve as Business Process Owner for TMF and supervise Business Process Owner for Registry
- Develop and execute strategy for continuous TMF quality and efficiency improvements
- Manage and develop global distributed TMF and Registry operations organization of >150 colleagues globally
- Continually monitor organizational effectiveness to ensure efficient, SLA based global TMF and registry operations with highest quality
- Develop standards, tools and analyses to ensure a complete and accurate TMF across the enterprise, including identifying opportunities to improve process performance
- Establish and deliver TMF analytics and performance data (including audit, SQE and inspection data) to identify and mitigate risk and performance issues across portfolio, functional lines, preferred CROs and process
- Chair TMF Study Owner Community of Practice and lead cross global functional SME network
- Serve as Pfizer’s named individual responsible for clinical Trial Master File archival in accordance with EU Good Clinical Practice requirements
- Utilize operational performance data to characterize state of control and improvement opportunities
- Oversee the effective business support for business users of Registry across Pfizer and vendor partners
- Sponsor, lead, design and execute remediation improvement projects related to TMF and Registry
- Provide TMF guidance and focused support to asset teams and pivotal study teams that have a high likelihood of regulatory inspection, leading the team through pre-submission TMF deep dives
- Minimum of bachelor’s degree or equivalent required. Master’s or higher degree is preferred.
- At least 15+ years of relevant experience is preferred in clinical development, quality management, quality assurance, CAPA management, audit and regulatory inspection process
- Advanced knowledge and experience in GCP
- Ability to work successfully with internal and external partners; strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organization
- Experience of leading global initiatives or project teams. Knowledge and understanding of diverse needs of different regulatory requirements of different sites and countries.
- Experience with vendor management and oversight
- Knowledge of clinical and regulatory quality requirements across Pfizer markets preferred
- Experience with Clinical Trial Execution and Documentation preferred
- Experience supporting regulatory submissions and inspections preferred
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