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Project Manager - Jd 1022

Quantum Leap Healthcare Collaborative
San Francisco, CA
  • Posted: over a month ago
  • Full-Time
Job Description

POSITION:         Project Manager                REPORTS TO:    Leader, Clinical Trials

The Project Manager developments and ensures compliance with clinical study protocols that involve human subjects. They will oversee and resolves operational aspects of clinical studies or trials in conjunction with project team members and in accordance with standard operating procedures and good clinical practice and other regulations.  The Project Manager assist with financial matters associated with clinical trials and vendor selection.  The Project Manager is a technical leader with a high degree of knowledge in the overall field and recognized expertise in specific areas; problem-solving frequently requires analysis of unique issues / problems without precedent and / or structure.  They may manage programs that include formulating strategies and administering policies, processes, and resources; functions with a high degree of autonomy.  The Project Manager applies extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity.


The I-SPY Consortium is a series of large scale, platform clinical trials projects sponsored and operated by Quantum Leap Healthcare Collaborative with goal to drive innovation in breast cancer treatment and drug approval process. The program is currently comprised of four major initiatives, a nationwide phase 1 program, two networks (one for phase 2 drug screening trials called I-SPY 2 TRIAL and one for phase 3 confirmatory trials), and a newly formed I-SPY 2.2 Program.  The Project manager is involved with the management and project development of the I-SPY 2 TRIAL and associated projects. This position works with relevant sponsor organizations and relevant pharmaceutical companies, to develop a regimen and associated protocol for new drugs in the trial, ensure the regimen is compliant with internal I-SPY 2 policies as well as state and federal regulatory compliance under good clinical practice, and working to operationalize the new drug arms at all sites. In addition, the Project Manager will provide oversight and assist with development of other sub-studies under the I-SPY 2 umbrella including working with relevant groups to assess feasibility and development of project and associated operationalizing of projects.



I-SPY 2 Trial Project Manager is

  • Responsible for working with senior I-SPY program staff at UCSF and the Site Operations Chair to provide oversight and participating 25 cancer centers across the US for delivery of key trial goals and objectives
  • Responsible for executing and monitoring projects plans and timelines to ensure deliverables are met including but not limited to tracking and analyzing accrual trends and data completeness at participating sites, compiling reports, and making recommendations the I-SPY 2 Executive Committee
  • Gather, analyze, and compile recommendations on new potential sites
  • Monitors compliance with all policies and processes. Adheres to standards, external guidelines, university policies and regulations.
  • Serves as the main liaison between the clinical trials’ academic leaders. Proposes solutions to difficulties arising from multidisciplinary research, implements structural changes to maximize time efficiency within the constraints of limited resources.
  • Development of new agent concepts and adaptation into trial
  • Development of Standard Operating Procedures for trial work
  • Functions as a lead in the development of new processes and protocols with project team for highly complex clinical trials. Oversees and manages protocol amendments.
  • Conducts large project feasibility assessments. Analyzes risks, strategies and solutions. Develops project timelines and key milestones for assigned projects
  • Responsible for maintaining and updating the I-SPY 2 protocol and Manual of Operations including assessing the feasibility of the proposed updates
  • Additional ad hoc I-SPY related duties as assigned



  • 10 or more years of experience and advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory requirements.
  • Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
  • In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems.
  • Advanced communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator.
  • Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others who do not report to them in order to achieve common goals.
  • Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Advanced knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
  • In depth ability to work collaboratively with other cross-functional teams. In depth ability to interface, collaborate and influence / persuade other members of an extended study team.



  • Bachelor's degree in related science area and / or equivalent experience / training (10+ relevant years of experience).
  • Advanced degree in related area (MD, PhD, MPH, MS, etc.) preferred

Quantum Leap Healthcare Collaborative


San Francisco, CA
94158 USA



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