ImmunOptimize Network Clinical Trials Operations Manager

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 worlds 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 worlds deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration compassion determination excellence innovation integrity and respect. 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.

Job Summary:

The Infectious Disease Sciences (IDS) Program of the Vaccine and Infectious Disease Division seeks a versatile and experienced Clinical Trials Operations Manager (CTOM) to serve as a key foundational hire. This individual will manage coordinating center operations provide site coordination and protocol development support oversee cross-functional collaboration and ensure strategic outreach contributing directly to the development of a nationwide clinical trials Network. This role spans operational oversight strategic planning stakeholder engagement communications study implementation and team building. This position will play a critical role in the initial network infrastructure building efforts to ensure communication collaboration staffing and preparedness to launch the initial studies and trials. The role will require working directly with the leading faculty and staff in the Infectious Disease Sciences (IDS) Program in the Vaccine and Infectious Disease Division to ensure the rapid deployment and success of network coordinating center operations. This positions day-to-day operations focus is being responsible for all facets of the network development activities including overseeing site operations communicating network support needs with internal departments and external organizations sponsors and agencies and interacting effectively with the IDS program teams in research administration regulatory affairs program and division senior leadership (scientific and administrative). The position is expected to work independently within a framework of established regulations and guidelines and demonstrate initiative capabilities and strengths in addressing problems and advancing outreach efforts.

The CTOM will work under the direction of the Chair of the Scientific Advisory Committee of the ImmunOptimize Network and report to the Senior Program Operations Director of IDS/VIDD.

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.

Network Operations and Initiatives Management

• Manage network operations to support the networks leadership and scientific committees.
• Support the ImmunOptimize Network PI(s)/Advisory Committee and IDS Program leadership in many facets of the network development activities. This includes the development of information/system/website and training materials etc. following up on action items and generating guidance and committee documents.
• Develop and manage networks project charters timelines and deliverables on project-specific activities and initiatives.
• Establish relationships with sponsors advocates and collaborate with internal and external contacts and stakeholders including communications marketing philanthropy legal consultants and vendors to develop and maintain network documentation and monitor work progress.
• Collaborate with cross-functional teams input and support regulatory legal communications and marketing and grants/contracts teams to ensure timely approvals and results.

Site Operations Coordination and Protocol Support

• Ensure efficient protocol start-up and implementation at study sites by facilitating and liaising between sites other functional units with the network sponsor(s) and others as needed.
• Coordinate development of regular study procedures protocols cross-institutional contracts and agreements regulatory approvals and trial management.
• Serve as the primary liaison with clinical trial sites; manage and support protocol development efforts for network-wide studies across multiple sites.
• Organize and facilitate meetings to drive agendas and project timelines.
• Troubleshoot site and study-related operational issues and escalate as needed.
• Support development of sites and facilitate action plans in collaboration with sites and network leadership.
• Monitor ongoing site needs trial enrollment key timelines and develop supportive materials and training content.
• Assist prepare and contribute to scientific and technical documents (e.g. abstracts publications reports).

Network Outreach & External Partnerships

• Lead outreach and coordination with donors sponsors strategic partners and patients (advocates).
• Participate in the design and implementation of a stakeholder engagement strategy in consultation with program/network leadership and patient advocates/groups including identifying roadblocks to resolve conflicts and delays and to build trust and accelerate engagement and enrollment goals.
• Represent the network in external meetings and provide timely follow-up and documentation.
• Develop tools for stakeholder engagement relationship management and public outreach.
• Support development of sponsorship materials partnership proposals and related content.

Communications Infrastructure and Team Building

• Lead the development and management of the network website marketing and social media strategy.
• Support and manage foundational documents and platforms including a network website MOP Relevant SOPs communication strategy study manuals publications and authorship policies and data sharing and access guidelines etc.
• Partner with science writers and PIs to support development of grants papers and other publications.
• Manage personnel administrative functions for network coordinating centers staffing needs and develop and administer the networks departmental personnel policies and procedures.
• Support future hiring by helping define roles recruiting and onboarding new team members.
• Help establish the networks operating structure workflows and collaborative tools with administrative and clinical coordinator support.

MINIMUM QUALIFICATIONS

• Bachelors degree
• 7 years of experience in clinical research or research team management where leadership and team support abilities are practiced and enhanced
• Highly motivated self-starter quick learner who can work nimbly and adapt to the challenging demands in a fast paced professional environment
• Experience working with clinical trial processes and systems especially in supporting PIs and site teams
• Excellent computer skills including familiarity to use a wide variety of software for research data management and flexibility to learn clinical research databases
• Excellent interpersonal skills with the ability to build strong relationships with a diverse group of stakeholders
• Excellent oral and written communication skills

PREFERRED QUALIFICATIONS

• Advanced degree (i.e. PhD MPH MHA MBA etc.) in public health research administration or a related discipline.
• Experience with sponsor funder and patient advisors communication and relationship development.
• Familiarity with federally funded clinical research non-profit sponsors or public health initiatives.
• A thorough understanding of clinical trial conduct and of regulations as they relate to clinical trials including INDs.
• Demonstrated experience in managing multi-site trials including site management and clinical trial operations and ability to juggle multiple project deadlines and stakeholder perspectives.
• Experience launching or scaling a new research network or program.
• Familiarity and experience with AI applications and uses in clinical research.
• Technical writing/support experience (SOPs policy documents grants and scientific publications).
• Experience with social media and communications especially from a non-profit perspective

The annual base salary range for this position is from $115170 to $182020 and pay offered will be based on experience and qualifications.

This position may be eligible for relocation assistance.

This position is not eligible for H-1B sponsorship at this time.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health well-being and financial security. Benefits include medical/vision dental flexible spending accounts life disability retirement family life support employee assistance program onsite health clinic tuition reimbursement paid vacation (12-22 days per year) paid sick leave (12-25 days per year) paid holidays (13 days per year) and paid parental leave (up to 4 weeks).