research collaboration project senior manager 4961539

The Research Collaboration Project Manager provides project management for externally-Sponsored, Pfizer supported research collaborations to ensure alignment and execution of research, development, and medical strategic and operational goals. The responsibilities encompass strategic planning, oversight, resource management, and risk management of research collaborations within assigned therapeutic area(s), including acting in the role of Study Manager for the highest-priority studies when needed. The RC Project Manager needs to have a comprehensive understanding of clinical study regulations (GCP, ICH, etc.), internal governance processes, and project management skills that support the planning, communication, and continuous improvements in operational delivery.

Key Responsibilities:

• Oversee one or more therapeutic areas that engage with external collaborators, including principal investigators, academic research organizations, cooperative or network, relevant government agencies, other pharmaceutical companies, alliance partners, and any vendors that support research collaboration activities.

• Champion operational excellence to provide continuous improvement of processes and sharing of best practices and participate in efforts to improve research collaboration functions globally across an asset program.

• Offer leadership in planning, risk management, and internal/external communication and stakeholder management strategies.

• Manage a portfolio of studies and oversee the studies and Study Managers within the assigned therapeutic area.

• Lead internal and external study team meetings and capture meeting minutes and actions.

Initiation

• Conduct initial review for completeness and classification of research collaboration proposals, entry of information into the research collaboration system, and requests for additional information or documentation through the entire lifecycle of assigned research collaboration studies.

• Oversee research collaboration due diligence activities internally and ensure due diligence activities are completed by the appropriate functional line subject matter experts.

• Lead due diligence meetings as needed to provide insights and guidance to team members.

• Oversee and monitor due diligence action items and decision-making.

Planning

• Facilitate the development of the research collaboration agreement, budget, and study plans between Pfizer and external collaborator(s).

• 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 forecasts as required.

• Ensure all lines understand how the research collaboration study fits into the asset strategy, key milestones, and interdependencies.

• Develop and monitor timelines, milestones, and risk mitigation strategies.

• Ensure appropriate resourcing to support the execution of the research collaboration and escalate concerns as needed.

• Collaborate with internal and external partners and stakeholders.

• Respond to queries from Pfizer leadership about the status of assigned research collaboration proposals, studies, and research collaboration policies and procedures and other internal and external stakeholders, as required.

• Serve as the primary operational contact with external collaborator(s), research sites, cooperative groups, and public or private sector intergroups and networks globally to facilitate the process and execution of research collaboration studies within the assigned therapeutic area and ensure compliance with research collaboration policy, global and local healthcare laws.

• Consult with drug and regulatory subject matter experts to align on strategies for each research collaboration.

• Facilitate the development of study-related documents (protocol, ICD, etc.).

• Facilitate the efficient and accurate creation of contracts and amendments for research collaboration studies – new or ongoing – with Legal. Lead contract negotiations as needed.

Monitoring and Closure

• Proactively identify and manage emerging changes and opportunities; drive iterations of the plans collaboratively with the team to make updates in the project schedule.

• Manage study progress reports and results for overall compliance and recommend corrective action or study termination for non-performance.

• Closely monitor progress against goals for operational efficiency, ensuring the program delivers on time, within scope, and on budget.

• Identify and manage compliance risks for assigned studies and oversee the same for the assigned therapeutic area.

• Ensure closure activities are complete.

Training and Education

• Monitor research collaboration process and training needs.

• Assist in curriculum development and training in research collaboration operational strategies and compliance regulations.

• Adhere to applicable SOPs, written standards, working practices, and implementation guidelines for the research collaboration process, as required, and contribute to their development.

• Serve as a trainer/mentor for research collaboration study managers, medical/clinical leads, and functional lines subject matter experts on research collaboration policies, procedures, and systems.

• Understand and communicate team roles/responsibilities; help new team members get up to speed on the project and ensure all team members have access to project information necessary to be successful.

• Ensure all appropriate team member views have been acknowledged and incorporated into team decisions as appropriate.

Qualifications

• Bachelor's Degree

• 7+ years of experience

• Applicable pharmaceutical industry experience

• Working knowledge of Good Clinical Practices, monitoring, clinical, and regulatory operations

• Demonstrated project management/leadership experience

• Experience with vendor oversight

• Ability to evaluate, interpret, and present complex issues and data to support risk

• Excellent communication skills, both written and verbal; must be fluent in English

• Effective decision-maker, analytical, and solution-oriented

• Proficiency in Microsoft Office Suite and familiarity with the use of AI.

Preferred Qualifications

• Master's degree, advanced education, and/or training/experience preferred

• Experience in developing and managing contracts

• Demonstrated effectiveness in working in a multidisciplinary, matrix team situation, and demonstrated abilityto manage change

• Project Management (PMP) certification

• Pharmaceutical industry experience preferred

• Managing clinical studies in a global environment highly desirable