Protocol Development Project Manager

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Protocol Development Project Manager plays a key role in driving the efficient creation, development, and finalization of high-quality protocol documents for oncology, investigator-initiated trials (IITs). The Project Manager is responsible for coordinating input from a range of stakeholders—including Principal Investigators (PIs), biostatisticians, clinical operations teams, science writers, and regulatory affairs professionals—to ensure comprehensive and timely reviews. This role will be responsible for self-directing large, complex projects from initiation to completion. This is an opportunity to join a dynamic team within the central clinical trials office, Clinical Research Support (CRS), and contribute to advancing research through effective protocol development.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Responsibilities

• Serve as a central point of coordination for the investigator-initiated trial protocol development process, managing timelines, deliverables, and stakeholder engagement.
• Create, update, and manage standard operating procedures (SOPs), process maps, templates, and guidance documents to ensure a streamlined, robust, and efficient protocol development process.
• Collaborate with Principal Investigators (PIs), biostatisticians, clinical research staff, and regulatory teams to design and develop study protocols.
• Critically review protocols for consistency, high-level operational, and institutional considerations.
• Establish, monitor, and drive protocol development project plan and timelines, ensuring milestones are met.
• Provide document management and version control of all protocol revisions.
• Manage internal and external stakeholders, fostering effective communication and collaboration.
• Organize and facilitate cross-functional team meetings, tracking action items and key decisions to maintain progress.
• Oversee updates to protocols, coordinating feedback from the PI, statistician, and study staff to incorporate revisions into a final cohesive document.
• Support hand-off of protocol and supplementary documents to research/start-up teams.
• Support protocol revisions through all required approvals (i.e., IRB) and downstream amendments. 
• Ensure protocols adhere to all institutional policies, procedures, and regulatory requirements for final submission.
• Perform other duties as assigned to support the team and organizational goals.

Qualifications

MINIMUM QUALIFICATIONS:

• BA/BS in related field or equivalent experience required. 
• Minimum of five years related project/study management experience with a master's degree or seven years' experience with a bachelors in a research setting.
• Demonstrated ability to successfully self-direct projects from initiation to completion.
• Knowledge of clinical protocol development, review and approval process.
• Familiarity with applicable federal regulations and guidelines pertaining to clinical research, including IND applications.
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