Director, Lab Data Management

Overview
Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

The Statistical Center for HIVAIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center primarily focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees, and is currently managing over 40 active phase I - III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Director of the Lab Data Management (LDM) team. The Director of LDM is responsible for overall leadership and management of the laboratory data management group at SCHARP. The Lab Data Management Director is a member of SCHARP's senior management team and this leadership role, partners with the SCHARP Executive Director, other SCHARP unit Directors, and the LDM data managers to develop department-wide strategy, vision, mission, infrastructure, policies and standards. The Director, LDM oversees and coordinates lab data management strategic projects and protocols and acts as liaison to other groups at SCHARP as well as external customers.

Responsibilities
Provide strategic, organizational, and operational management and guidance to the Lab Data Management group.
Collaborate with the other SCHARP Directors to create and implement overall organizational vision and strategic direction.
Act as lab data management liaison/lead and develop strong working relationships and maintain effective communication with clients, research partners, colleagues and with external labs.
Optimize interdisciplinary understanding and teamwork across functions to drive effective and efficient lab data management practices.
Monitor LDM project and protocol workflows, capacity, priorities, timelines, deliverables, documentation, and resources.
Foster and promote the long-term development of the Lab Data Management group.
Develop and maintain staff morale, engagement, and professional development Provide training, direction, and performance management for individual employees.
Provide organizational leadership, support collaboration and team building, facilitate cross-group interactions.
Provide functional oversight of the day-to-day work and work products of lab data management staff, including the development of inbound laboratory data pipelines, processing, and quality control procedures and the development and management of SCHARP lab data standards.
Provide technical vision and guidance on the development of infrastructure needed to support lab data management for regulated Phase I/II/III clinical trials and the various R&D/pre-clinical studies.
Lead departmental efforts to standardize work practices and develop standard operating procedures in conformance with GCP, GCDMP, and ICH guidelines, and that meets regulatory submission requirements, and CDISC standards, where applicable.
Identify, oversee, and implement process improvements of SCHARP procedures and practices by chairing and/or participating on teams, committees and working groups.
Oversee and ensure quality assurance of lab data management in coordination with the Quality Management section.
Evaluate and identify efficiencies and process improvements including leading infrastructure and technological upgrades as needed to improve the LDM intake, workflow, documentation and tracking and project/protocol management.
In partnership with SCHARP's Senior Management Team and the Project Management Steering Committee prioritize and manage the implementation of SCHARP continuous quality improvement, regulatory compliance, operational effectiveness, and technical infrastructure improvement LDM projects.

Qualifications
Minimum:

Master's degree in Science, Public Health, or similar degree in a scientific, technical or health-related field with 8+ years of experience in clinical and/or lab data management or related disciplines or equivalent combination of experience and education.
At least 5 years of experience in direct staff supervision/management.
In-depth understanding of standard approaches to data collection, data cleaning and processing, and impacts to research analysis activities
Demonstrated leadership skills and excellent communication skills.
Preferred:

Doctoral degree in biological or science field.
Knowledge of laboratory assay development and immunogenicity/virology assays.
Project and/or program management training and/or experience.
Experience managing complex teams/operations and contributing to high-level organizational strategic planning and decision-making.
Familiarity with GCP, GLP, GCDMP, and CDISC standards.