Research Collaboration Project Manager

Company: Pfizer
Location: Olympia
Posted on: November 15, 2022

Job Description:

Role SummaryResearch Collaborations (RC) are research studies where Pfizer, Inc. partners with an external collaborator(s) to develop, conduct and execute research that would be used to support Pfizer business or regulatory goals. The Research Collaboration (RC) Project Manager provides project management for Pfizer supported RC to ensure alignment and execution of research, development and medical strategic and operational goals. The RC project manager (RC-PM) responsibilities encompass strategic planning, oversight, resource management, and risk management of RCs within assigned Therapeutic Area(s). The RC PM will be in support of one or more assets and/or Business/Research Units that engage with external (third party) collaborators that include but are not limited to principal investigators, Academic research organizations, cooperative or network, relevant government agencies (e.g., NIH, NCI), other pharmaceutical companies, , alliance partners, and any vendors that support CRC activities. The RC PM needs to have a comprehensive understanding of the governance process, strategic and tactical planning and foundational tools that support the planning, communication, and continuous improvements in the area of operational delivery. Internally, the RC Project manager is the primary/secondary Point of Contact for Pfizer colleagues, including TA Medical Teams (within the Business Units and Research Units), Field Medical, PCOs, and Regions, Worldwide Research and Development, Pharmaceutical Sciences, Contracts & Outsourcing, Safety & Risk Management, Outcomes Research, Project Management, Legal, Regulatory, and Finance interested in supporting a RC. The RC Project Manager also monitors the RC-related systems and educational needs of internal and external stakeholders to maintain compliance with Pfizer's RC policies and guidelines as well as external healthcare law throughout the process. The RC Project manager will champion operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve RC functions globally across an asset program.Role ResponsibilitiesAsset/Program Development, Strategy and Planning for RC

• Partners with the Medical Affairs, Clinical Development, AND/OR Research Unit business(es) to develop the strategic plan to support RC to ensure alignment with the overall asset/business development and lifecycle plan.
• Offers leadership in planning, including identifying appropriate Collaborators and options for execution, risk management, and internal/external communication and stakeholder management strategies.
• Conducts initial review for completeness and classification of RC proposals, entry of information into the RC system, and requests for additional information or documentation through the entire lifecycle of assigned RC studies.Oversees CRC Due Diligence Activities Internally
  • Ensures RC Due diligence activities are completed by the appropriate Functional Line Subject Matter Experts (SME)
  • Participates in Due Diligence Meetings as needed to provide insights and guidance to DD team members.
  • Oversees and monitors Due Diligence action items and decision making,
  • Assisting in the development of the RC agreement and Quality plans between Pfizer and external collaborator(s).Project Planning
    • In partnership with the Medical/Asset Team, Finance Lead, and Partner Line representatives, accountable for developing and maintaining an integrated program level budget and accurate updated annual forecasts.
    • Ensures all lines understand how the RC study fits into the asset strategy, key milestones and interdependencies.
    • Develops timelines, milestone and risk mitigation strategies
    • Ensures appropriate resourcing to support the execution of the RC including Wuhan and RC study manager and to escalate concerns to manager
    • Monitors RC progress and milestones to ensure on track with projected timelines and to escalate to team if off trackCollaborates with internal and external partners and stakeholders
      • Responds to queries from Pfizer and RU/BU ELTs about the status of assigned RC proposals, studies, and RC policies and procedures and other internal and external stakeholders, as required.
      • Primary contact with external Collaborator(s), research sites, co-operative groups and public or private sector intergroups and networks globally to facilitate process and execution of RC studies within assigned TA and to ensure compliance with CRC policy, global and local healthcare laws.
      • Provides oversight of PCO and Regional colleagues as required for management of RCs globally as needed.RC Execution and Delivery
        • Manages Drug and Regulatory strategies for each RC
        • Works with RC Study manager, Wuhan and Medicinal Sciences colleagues to maintain adequate drug supplies, including pooled supplies when feasible and appropriate.
        • Facilitates and monitors the efficient and accurate creation of contracts and amendments for RC studies - new or ongoing - with Legal. Assists with contract negotiations if needed
        • Serves as Project Manager for all assigned RCs
        • Proactively identifies and manages emerging changes and opportunities; drives iterations of the plans collaboratively with the team to make updates in the project schedule
        • Manages study progress reports and results for overall compliance and recommends corrective action or study termination for non-performance.
        • Closely monitors progress against goals for operational efficiency ensuring the program delivers on time, within scope, and on budget.Monitors RC process and educational needs
          • Assists in curriculum development and training in RC operational strategies and compliance regulations
          • Adheres to applicable SOPs, written standards, working practices, and implementation guidelines for the RC process, as required and contributes to their development.
          • Serves as a trainer for new RC-PMs, RC Study managers, Medical/Clinical Leads and Functional Lines SMEs on RC policies, procedures, and systems
          • Understands and communicates team roles/responsibilities; helps new team members get up to speed on the project and ensures all team members have access to project information necessary to be successful.
          • Ensures all appropriate team member views have been raised and incorporated into team decisions as appropriate.
          • Identifies team performance issues and partners with team leadership to recommend and develop appropriate actions.
          • Participates in task forces to evaluate and continuously improve RC processes and systems, as required and shares best practicesQualificationsBASIC QUALIFICATIONS
            • Minimum of a BS/BA is required with preference for a focus in science or biomedical discipline.
            • Minimum7 years' experience in clinical study management and Project management
            • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
            • Strong knowledge of Therapeutic Area(s), subject matter expertise and international experience are desirable.PREFERRED QUALIFICATIONS
              • Master's degree; advanced education and/or training/experience preferred.
              • Demonstrated effectiveness in working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change.
              • Project Management (PMP) certification
              • Pharmaceutical industry experience preferred
              • Managing clinical studies in a global environment highly desirable
              • Demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.OTHER INFORMATION
                • Work Location Assignment:Remote
                • Last Date to Apply: 11/20/2022Relocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer 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 EligibilityPfizer 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.Medical

Keywords: Pfizer, Olympia , Research Collaboration Project Manager, Executive , Olympia, Washington