Clinical Trial Manager
Clinical Development | San Francisco, Ca | Full Time
he Parker Institute for Cancer Immunotherapy (PICI) is radically changing the way cancer research is done. Founded in 2016 through a $250 million gift from Silicon Valley entrepreneur and philanthropist Sean Parker, the San Francisco-based nonprofit is an unprecedented collaboration between the country’s leading immunotherapy researchers and cancer centers, including 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. The institute also supports top researchers at other institutions, including City of Hope, Dana-Farber Cancer Institute, Fred Hutchinson Cancer Research Center, Icahn School of Medicine at Mount Sinai, Institute for Systems Biology and Washington University School of Medicine in St. Louis.
By forging alliances with academic, industry and nonprofit partners, PICI makes big bets on bold research to fulfill its mission: to accelerate the development of breakthrough immune therapies to turn all cancers into curable diseases.
Help us create a world that doesn’t fear cancer. Join us. www.parkerici.org
Overview of the Role
The Clinical Trial Manager will play a pivotal role in ensuring alignment between organizational and clinical strategy, operational structure, formalized processes and execution. The Clinical Trial Manager together with 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 Clinical Program Manager 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 Trial Manager will report to the Clinical Program Manager and interface with other department representatives as well other departmental leaders within the organization. The Clinical Trial Manager will be a key member of the Clinical Development team.
Essential Job Functions
- 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.
- Lead the cross functional study team and ensure timely delivery of project deliverables with minimal oversight.
- Interface directly with the Clinical Program Manager 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.
- Manage trial vendor day-to-day activities as needed.
- Participate in business life cycle and trial planning. Develop processes and workflows to ensure efficient implementation and evaluation of clinical trials.
- In collaboration with Clinical Program Manager 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 level documents for protocol implementation.
- Provide trial Investigational Product (IP) projections and work with external partners to facilitate and ensure IP supply needs are met.
- 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 trial progress, milestones and elevation of issues, as appropriate, to management and stakeholders as needed.
- Perform risk mitigation planning and implementation for clinical trials.
- Contribute to the development of clinical operating processes, standard operation procedures and departmental documentation and initiatives.
- Support for specific Trial Master File.
- Perform all duties in keeping with the organization’s core values, policies and applicable regulations.
- Willingness to travel (< 20% expected).
Knowledge, Skills and Experience
- 3 years minimum clinical trial experience with at least 1 year of on-site monitoring experience and 2 years combined on-site monitoring and trial management, preferably at the Sponsor level.
- Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects.
- Bachelor’s degree required, preferred MA/MS degree with major in biological, life science, nursing or related field.
- Experienced in managing early development phase clinical trials, immuno-oncology trials experience preferred.
- Ability to build, sustain and grow relationships with investigators, clinical research personnel and internal team members.
- 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/critical thinking skills