Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

Job Description

Drive GCP quality in documentation, operational data and withstanding regulatory scrutiny. This position will focus primarily in Trial Master File Operations. Facilitate the execution of the TMF Operations’ activities to enable complete, compliant and consistent study TMFs for interventional studies across the portfolio through robust processes, controls, analytics, training and change management.

Primary duties may include, but are not limited to the following. Individuals may be assigned to particular areas of focus (e.g. TMF, inspection readiness, audit coordination).

Trial Master File (TMF)

• Maintain, update and improve processes related to TMF, including development and execution of control plans

• Utilize operational performance data to characterize state of control, improvement opportunities and drive process and system optimization

• Deliver effective business support for 8,000 business users of TMF across Pfizer and vendor partners, including direct support for TMF Study Owners and Wuhan Document Specialists

• Partner with CD&O-Information Management in the acquisition and divestiture of TMF content while developing repeatable efficient process for TMF in integrations

• Lead design and execution of remediation projects and improvement projects

• Configure Study-Specific Document List algorithms to address rapidly changing business needs

• Manage investigator record retention program across Pfizer clinical trials

• Drive performance of CRO against TMF requirements, including TMF Study Ownership and Clinical

• Document Management functions

• Coordinate TMF Lock process & activities across clinical trial portfolio

• Identify and resolve operational issues and continuous improvement opportunities related to TMF

• Monitor and manage the TMF performance and metrics

• Conduct analysis to identify trends for intervention and additional training and education

• Coordinate and track TMF-related CAPA remediation activities

• Facilitate TMF remediation activities

• Contribute to the TMF integration for planning and execution of acquisition, collaboration and divestiture (ACD) activities

• Provide guidance to Study Teams to answer questions related to legacy TMF systems and archive

• Support TMF document control efforts in preparation and participation for internal audits and external regulatory agency inspections

Qualification/Skills

• Minimum of bachelor’s degree or equivalent required. Master’s or higher degree is preferred

• At least 10+ 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

• Project management, resource management, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization

• Advanced Continuous Improvement belt preferred and experience in large scale change initiatives

• 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

• Appreciation of diverse needs of different regulatory requirements of different sites and countries.

• Relevant experience in information management and data analysis preferred

• Relevant experience in the drug development process (including the various types of records created and how the information is used to support the business)

• Knowledge of quality requirements across a range of different countries

• Clinical Trial Execution

• Clinical Documentation

• Vendor Management and Oversight

• Experience supporting regulatory submissions and inspections preferred

• Electronic documentation management systems Clinical Trial Management Systems and operational data management system

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