Clinical Program Manager
Clinical Development | San Francisco, Ca | Full Time
Overview of the Role
The Clinical Program Manager will play a pivotal role in ensuring alignment between organizational and clinical strategy, operational structure, formalized processes, and execution. The Clinical Program Manager provides leadership to one or more cross functional protocol teams to ensure that high quality deliverables are met within budget and timelines. Key to the success of this effort will be the planning and implementation of clinical trials conducted at one or more member institutions as well as a network of sites external to the consortium, as appropriate.
This individual will work closely with the executive team to ensure key projects are defined, aligned with the organization’s strategic plan and critical success factors are proactively led, managed, and executed for timely delivery. S/he will coordinate internal and external clinical communications, collate team discussions into actionable items, assemble various reports including dashboards, excel, meeting actions/agreements and analyses, and assist with long and short term goal setting and planning construction.
Reporting Structure and Team
The Clinical Program Manager reports to the VP, Clinical Development and is a key member of the Clinical Development team.
Essential Job Functions
- Full accountability for the clinical trial(s) including timelines, budget, resourcing, execution and delivery in line with PICI mission and deliverables. Accountability spans for all phases of study including feasibility and planning, startup and closeout.
- Independently lead the cross functional study team and ensuring timely delivery of project deliverables with minimal oversight
- Interface directly with the Director of clinical operations to ensure proper resourcing, identifying gaps and maintaining timelines.
- Delegate to other team members as appropriate to the role. Oversee delegated activities. Provide expertise, support and mentoring to clinical operations team staff members
- Responsible to select and manage trial vendors such as CRO, central laboratory
- Participate in business lifecycle and program planning. Develop processes and workflows to ensure efficient implementation and completion of clinical trials.
- In collaboration with Director and finance representative, provide input for planning, managing, reporting out and site payment tracking for a study budget.
- Ensure relevant functional groups provide and participate in the development of study plans and finalization of study-team level documents for protocol implementation.
- Provide study drug projections and work with external partners to facilitate drug ordering processes
- Have responsibility for establishing and monitoring clinical project and organization-building project goals as well as criteria for all key decision points.
- Report out on program progress, milestones and elevation of issues, as appropriate, to management. Perform risk mitigation planning and implementation as needed.
Knowledge, Skills, and Experience
- 6 years minimum clinical trial study management and leadership in drug development
- Working knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects
- Bachelor’s degree, preferred MA/MS degree with major in biological, life science, nursing or related field
- Experienced in managing early development phase clinical trials, experience in immuno-oncology trials preferred
- At-risk planning strategies, site budgets, site selection, clinical material and supply management, conduct and monitoring of clinical studies
- Ability to work independently with minimal supervision and prioritize work deliverables to ensure the completion of essential deadlines
- Strong planning, communication, organizational and analytical skills
- Willingness to travel to site visits and relationship building
Introduction to the Organization
The Parker Institute for Cancer Immunotherapy (“PICI” or the “Parker Institute”) is a not-for-profit organization whose mission is to accelerate the development of immunological cures for cancer through innovative science, advanced technologies and new modes of research collaboration. The Institute is based in San Francisco, California and officially launched in April 2016.
To achieve its mission, PICI has established significant new cancer immunology research centers at six of the top cancer research and treatment institutions in the country (Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center), and will organize and support a portfolio of advanced, collaborative research efforts across this consortium.