Protocol Development Manager I

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

Fred Hutchinson Cancer Research Center, home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the Center's five scientific divisions collaborate to form a unique environment for conducting basic and applied science. The Hutchinson Center, in collaboration with its clinical and research partners, the University of Washington and Seattle Children's, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. Join us and make a difference!

The HIV Vaccine Trials Network (HVTN) is the world's largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity, to testing vaccine efficacy.

The PROTOCOL DEVELOPMENT MANAGER (PDM) manages the development of clinical trial protocols for HIV vaccines from concept to implementation, working with on-site and off-site protocol team members. The PDM establishes and maintains relationships, expectations, and collaborations, with principal investigators, vaccine developers, statisticians, sponsor representatives, laboratory staff, pharmacists, regulatory affairs staff, clinical safety staff, data management staff, community education staff, clinic coordinators, and community members. The Protocol Development Manager may assist authors with the drafting and editing of concept sheets, concept proposals, and clinical protocols, including informed consent forms.

- Establish and maintain relationships with stakeholders with varying expertise and interests including, principal investigators, vaccine developers, statisticians, NIH DAIDS medical officers, laboratory staff, pharmacists, regulatory affairs staff, clinical staff, and community education staff.
- Direct development of clinical trial protocols for HIV vaccines from concept to implementation in conjunction with the Protocol Team Leader.
- Manage development of documents and presentation materials for submission to funders, national regulatory entities, and other key audiences.
- Construct clinical development plans, including timelines, milestones, and key decision points.
- Contribute to the drafting and editing of protocols and related documents.
- Coordinate HVTN program initiatives encompassing multiple clinical trials, funders, and institutional stakeholders.
- Organize and facilitate program stakeholder meetings.
- Drive protocol development timelines; establish team meeting agendas and track ensuing action items.
- Orchestrate submissions, reviews, responses to reviewer comments, and reviewer sign-offs of draft protocol documents through FDA submission.
- Organize and facilitate protocol team two-day face-to-face meetings.
- Support study conduct following implementation by collaborating with the data management center Project Managers as needed.
- Assemble and process protocol modifications and amendments following implementation.
- Orient protocol team members to the HVTN protocol development process, and establish team member expectations and responsibilities. Each protocol team includes members within and outside of HVTN Leadership Operations Center (Core) in Seattle.
- Work with Protocol Team Leaders on special projects that may include literature and data reviews and grant and manuscript development.
- Serve as a resource to colleagues within and outside of the US regarding protocol and protocol-related document development and control.
- Serve as a resource for new employees.
- Attend twice yearly HVTN Meetings (out-of-state and out-of-country).

- Minimum of Master's degree. Knowledge of and experience with research methods and regulatory aspects of clinical trials.
- Excellent writing skills and scientific vocabulary capable of effective verbal and written communication with clinical research staff, health professionals, and clinical scientists required.
- Experience working in a global network with off-site collaborators. Demonstrated experience in managing multiple projects simultaneously with minimal supervision.
- High degree of organizational skills, logical thinking, and close attention to detail. Extensive MS Word experience; MS Project and Visio highly desired. Three or more years clinical trials experience preferred.
- Candidates should be comfortable with ambiguous information and have excellent customer service skills.

We are a VEVRAA Federal Contractor.

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2249772-2647-9821

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