Data Operations Associate Director

Fred Hutchinson Cancer Center•Seattle, WA

13d

About The Position

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 leads data and operations for the HVTN SDMC, coordinating and advancing its clinical-trial data and operations portfolio. The role manages SDMC activities, supports implementation of network strategic priorities, and helps ensure scientific, operational, data, regulatory, fiscal, and sponsor requirements are met across a complex, multi-site and international clinical-research program. The Associate Director builds and maintains relationships with internal and external collaborators, represents the HVTN SDMC’s multiple Principal Investigators in operational, cross-functional, and sponsor-facing discussions as appropriate, and facilitates communication, alignment, and decision-making among stakeholders. In partnership with HVTN SDMC Principal Investigators and Center leadership, the Associate Director oversees operational planning, performance monitoring, resource allocation, external vendors and services, and fiscal management. The role makes and implements day-to-day management decisions focused on data quality, data-management processes, study conduct, operational readiness, timelines, deliverables, risk management, and continuous improvement. It also contributes to evaluating SCHARP performance and implementing strategic decisions made by HVTN leadership and, if applicable, the Vaccine Leadership Team. The position reports directly to the HVTN SDMC Contact PI.

Requirements

Ph.D. in a field related to clinical research, such as data science, data management, clinical research program management focused on data, biostatistics, immunology, virology, or another quantitative health science; alternatively, a Master's degree with additional experience.
At least eight years of relevant experience with progressively increasing scope of responsibilities, including at least five years of management experience with supervision.
Experience working with complex groups in a clinical research and/or laboratory research environment.
Ability to travel in the United States and internationally, approximately two trips per year.
Experience working with clinical research data, including knowledge 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 developing and reviewing scopes of work, 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 and collaboratively within multidisciplinary teams with varying technical expertise, backgrounds, and leadership levels.
Ability to evaluate information quickly and frame ideas and arguments effectively.
Strong leadership, communication, and negotiation skills.
Ability to navigate complex interpersonal relationships in a matrixed organization.
Ability to view projects and activities from multiple perspectives and navigate complex organizations with competing priorities.
High scientific rigor and integrity.

Nice To Haves

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 in the United States and internationally.
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 such as HIV, TB, malaria, or polio; global health; social science; and implementation science.
Highly motivated, self-starting, and able to work independently with minimal direct supervision.

Responsibilities

Provide data and operations leadership, fiscal oversight, and management for research supported by the HVTN SDMC and related grants, including BARDA-funded and industry-sponsored research.
Ensure data capture and management systems are appropriate to clinical research studies while balancing effectiveness and cost.
Define a cohesive set of data and operations services and a research plan for the HVTN SDMC.
Monitor SCHARP activities and prioritize work to align with research and service goals; identify prospective external partners and solicit competitive proposals when appropriate.
Serve as a member of the Vaccine Leadership Team, keeping the HVTN SDMC Principal Investigators informed and obtaining regular feedback.
Establish working relationships with grant stakeholders, communicate SDMC priorities, obtain feedback about services, and direct activities to improve services.
Attend HVTN Laboratory and Leadership Operations Center meetings, establish relationships to obtain ongoing feedback, and perform similar engagement for other research projects, including sponsor meetings.
Engage and support faculty working on the HVTN SDMC grant and related vaccine clinical research programs, maintaining communication about resources and supported work.
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.
Identify critical-path dependencies and timeline risks, communicate status to Principal Investigators and sponsors, and negotiate and implement mitigation plans.
Develop and oversee research program and project budgets; review expenditure reports, forecasts, and effort allocation reports monthly and take corrective actions as needed.
Monitor costs in accordance with sponsor rules and regulations and Fred Hutch policy; recommend actions to manage budget deviations; develop protocol budgets with Principal Investigators, the Research Administrator, and SCHARP; and approve delegated invoices, travel requests, and other costs.
Prepare or oversee grant documentation and annual progress-report components concerning implementation of data- and operations-related specific aims, collaborating with the assigned Research Administrator in electronic systems.
Develop purchased-services scopes of work and oversee vendor and consultant performance with the Contracts & Vendor Management Team.
Review vendor and CRO scopes of work, work orders, and change orders for alignment with protocol requirements, budget, and timelines; track 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 research programs and projects in collaboration with IRO and the Research Administration team.
Maintain current knowledge of HVTN scientific agendas and priorities through collaboration and committee membership with other Network components.
Represent research programs and Principal Investigators at internal and external meetings and committees as needed.
Maintain current knowledge of HIV vaccine research through professional organizations, scientific conferences, and industry journals.
Supervise staff as assigned.
Perform other duties as assigned.