TEMP PROJECT MANAGER

POSITION:  TEMP Sr. Project Manager

REPORTS TO: Director, Clinical Operations

The Senior Project Manager developments and ensures compliance with clinical study protocols that involve human

subjects. They will oversee and resolve 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

Senior Project Manager assists with financial matters associated with clinical trials and vendor selection. The Senior

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 Senior 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 the goal to drive innovation in COVID and Oncology 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 ISPY

2.2 Program. The Senior 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 Senior 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 projects and associated operationalizing of projects.

GENERAL DUTIES AND ESSENTIAL JOB FUNCTIONS:

I-SPY 2 Senior 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 30+ 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 to the I-SPY 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 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.

● Prepares site Clinical Research Coordinator and Investigator presentations.

● Facilitates Clinical Trial Operations working group calls.

● 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 the 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 protocols and Manuals of Operations including assessing

the feasibility of the proposed updates.

● Additional ad hoc I-SPY related duties as assigned.

Skills/Competencies

● 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 deadlines 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 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.

Qualifications

● 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