Data Operations Associate Director

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. 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.

 

The Associate Director, Data and Operations for Infectious Disease Clinical Trials provides day-to-day leadership for data management and data-related clinical-trial operations and research activities supporting vaccine, monoclonal antibody, and other infectious-disease prevention studies. The position primarily supports the HIV Vaccine Trials Network Statistical and Data Management Center (HVTN SDMC), while also contributing to sponsored clinical trials and research programs involving quantitative data analysis for other pathogens, including TB, SARS-CoV-2, and other viral respiratory diseases.

 

The Associate Director (AD) provides data and operational leadership for the HVTN SDMC, with responsibility for coordinating, overseeing, and advancing the HVTN’s clinical-trial data and operations portfolio. This role provides day-to-day management of SDMC activities; supports the implementation of network strategic priorities; and helps ensure that scientific, operational, data, regulatory, fiscal, and sponsor requirements are met across a complex, multi-site and international clinical-research program.

 

The AD builds and sustains effective working relationships with internal and external collaborators, including leadership of the Statistical Center for HIV/AIDS Research (SCHARP), our data management partner; program operations staff in our academic home program, the Biostatistics, Biomathematics, and Epidemiology (BBE) Program; the HVTN Laboratory and Leadership Operations Centers; study teams; investigators; sponsors; and other research partners. The AD represents the HVTN SDMC’s multiple Principal Investigators (PIs), as appropriate, in operational, cross-functional, and sponsor-facing discussions, and facilitates timely communication, alignment, and decision-making among stakeholders.

 

In partnership with the HVTN SDMC PIs and Center leadership, the AD provides oversight of operational planning, performance monitoring, resource allocation, external vendors and services, and fiscal management. The role makes and implements day-to-day management decisions related to clinical-trials research, with particular emphasis on data quality, data-management processes, study conduct, operational readiness, timelines, deliverables, risk management, and continuous improvement. The AD also contributes to evaluating SCHARP performance and to implementing strategic decisions made by HVTN leadership and, if applicable, the Vaccine Leadership Team. The AD reports directly to the HVTN SDMC Contact PI.

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

• Provide data and operations leadership, fiscal oversight, and management for the research supported by the HVTN SDMC and related grants (e.g., the NextGen COVID-19 Vaccine Program funded by the Biomedical Advanced Research and Development Authority (BARDA), and industry-sponsored research projects). This includes ensuring that data capture and management systems are appropriate to clinical research studies, balancing effectiveness with cost.
• Define a cohesive set of data and operations services and research plan for the HVTN SDMC. Monitor SCHARP activities and prioritize work to match with research/service goals. Where appropriate, identify prospective external partners and solicit competitive proposals for services that support the SDMC.
• Serves as a member of the Vaccine Leadership Team that keeps the HVTN SDMC PI’s up to date with activities and obtains regular feedback.
• Establish working relationships with key grant stakeholders. Convey HVTN SDMC priorities, obtain feedback about services and direct activities within the HVTN SDMC and SCHARP to improve services. This activity includes attending existing HVTN Lab and Leadership Operation Center Program meetings as well as establishing new relationships to obtain ongoing feedback. Perform similar activities for other research projects (e.g., BARDA NextGen) including attending regular meetings with the sponsor.
• Engage and support faculty working on the HVTN SDMC grant and related vaccine clinical research programs and projects. Establish ongoing relationships with faculty and ensure there is open communication about resources and general awareness between the faculty and the PI of work being supported by the grant.
• Engage deeply in projects of critical importance such as key clinical trials.
• Develop, maintain, and manage integrated study and deliverable timelines with sponsors and external vendors, from study start-up through database lock, statistical deliverables, clinical study reports, and regulatory submissions.
• Proactively identify critical-path dependencies and timeline risks, communicate status to PIs and sponsors, and negotiate and implement mitigation plans.
• Develop and oversee research program and project budgets. Review budget expenditure reports, forecasts, and effort allocation reports monthly and take corrective actions as needed to ensure project scopes are completed within budget.
• The AD will have budgetary oversight for the research programs and projects. The incumbent needs to understand budgets and financial reports, monitor costs in accordance with sponsor rules and regulations and Fred Hutch policy, provide recommendations to manage budget deviations, develop budgets for protocols in partnership with the PI(s), Research Administrator, and SCHARP, and approve invoices, travel requests, and other costs as delegated by the PIs.
• Prepare and/or oversee components of grant documentation and annual progress reports. The AD is responsible for descriptions of how data and operations related specific aims of grants were or will be implemented and is responsible for completing sections of these grant applications and progress reports in electronic systems in collaboration with Research Administrator assigned to each project.
• Develop purchased services scopes of work and oversee performance of vendors and consultants in collaboration with the Contracts & Vendor Management Team. Conduct detailed review of vendor and CRO scopes of work (SOWs), work orders, and change orders to ensure alignment with protocol requirements, budget, and timelines; track contracted deliverables and payment milestones; and manage scope changes, amendments, and close-out.
• Provide day-to-day oversight of CROs and external vendors, including governance and operational meetings, key performance indicators, quality and issue management, escalation and corrective action, and review and acceptance of vendor-delivered data and deliverables.
• Manage compliance and IRB tasks for the research programs and projects in collaboration with IRO and Research Administration team.
• Maintain current knowledge of HVTN Scientific Agendas and Priorities through collaboration and committee membership with other Network components.
• Interact effectively with the scientific and organizational leadership of the research programs or projects, representing the program and the PI(s) at internal and external meetings and committees as needed.
• Maintain current knowledge of developments in the HIV vaccine research field, through participation in professional organizations, scientific conferences, and/or reading industry journals.
• Supervise staff as assigned.
• Other duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

• Ph.D. (or Master's degree with additional experience) in a field related to clinical research, e.g., data science, data management, clinical research program management focused on data, biostatistics, immunology, virology, or other quantitative health sciences such as epidemiology.
• Minimum of eight (8) years of relevant experience, progressively increasing scope of responsibilities, including at least five (5) years of management experience with supervision. Experience working with complex groups within a clinical research and/or laboratory research environment.
• Ability to travel in US and internationally. Approximately two trips per year.
• Experience working with clinical research data (e.g., knowledgeable of electronic data capture and data management systems).
• Detailed, hands-on clinical data management experience across the full study lifecycle, from study start-up through database lock and regulatory submission, including EDC systems, data management plans, data cleaning and reconciliation, and CDISC data standards.
• Demonstrated experience selecting, contracting, and managing CROs and external vendors, including SOW development and review, performance oversight, and timeline management with sponsors and vendors.
• Experience with financial management of a portfolio of federally funded and/or industry-sponsored clinical research projects, including budgeting and forecasting.
• Excellent oral and written communication and critical thinking skills.
• Ability to work autonomously as well as collaboratively within multidisciplinary teams of varying technical expertise, background, and leadership levels.
• Ability to evaluate information quickly, and frame ideas and arguments effectively.
• Strong leadership, communication, and negotiation skills.
• Navigate complex interpersonal relationships in a matrixed organization.
• Ability to view projects and activities from multiple perspectives and to navigate complex organizations with competing priorities.
• High scientific rigor and integrity.

PREFERRED QUALIFICATIONS:

• Experience and expertise with clinical trial statistical and data management deliverables involving operations and data.
• Experience working with immunological or virological data.
• Experience working with NIH grant application systems and policies and regulations for clinical trials (US and international).
• Experience with human subjects research and federal regulatory requirements.
• Experience working in complex and geographically diverse collaborative groups within a clinical research environment.
• Prior knowledge of infectious diseases (e.g., HIV, TB, malaria, polio, etc.), global health, social and implementation science.
• Highly motivated, self-starter, and able to work independently with minimal direct supervision.

The annual base salary range for this position is from $143,500 to $226,803, and pay offered will be based on experience and qualifications.

 

This position may be eligible for relocation assistance.

 

This position may be eligible for a sign-on bonus.

Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.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).

Additional Information

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at [email protected] or by calling 206-667-4700.