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Trial Master File Study Owner Process Lead
3 months ago
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 contentwhile 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
Organizational Relationships
- Role will interface with colleagues in Quality Center of Excellence, Medical Quality Assurance, Medical
- Regulatory Compliance, R&D Legal, Corporate Compliance, Worldwide Safety & Regulatory and Pharmaceutical Sciences and other key study team members such as the Clinician, Clinical Operations
- Study Team Lead and Compliance Oversight Lead, as well as Business Process Owners and staff at clinical trial vendors
- Partners with relevant platform lines and BUs/RUs and Alliance Partners to conduct training, lead awareness efforts, and promote/educate stakeholders (QA/Legal) about process quality and compliance.
- May escalate to or represent quality issues at governance meetings as necessary
Resource Managed
- May manage 10-30 contract resources and vendors providing services for TMF, Registry, QC Assessments, support TMF document control efforts in preparation and participation for internal audits and external regulatory agency inspections end-user support, independent quality reviews
- May direct activities of matrix resources in Wuhan supporting TMF, Registry, Inspection readiness and
- Audit Remediation
Work Location Assignment:On Premise
The annual base salary for this position ranges from $109,400.00 to $182,300.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | ). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
- The annual base salary for this position in Tampa, FL ranges from $98,400.00 to $164,000.00.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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