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 our pioneering work in bone-marrow transplantation, the five scientific divisions at Fred Hutch collaborate to form a unique environment for conducting basic and applied science. Fred Hutch, 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!
About the Division & Research Program:
The Vaccine and Infectious Disease Division (VIDD) was established as an institute at Fred Hutch in 2007 to facilitate and enhance the Hutch's efforts in infectious disease prevention and vaccine development. The institute achieved Division status in 2010 and now has more than 50 faculty members and houses the HIV Vaccine Trials Network (HVTN) - the world's largest clinical trials network for the development and testing of an HIV vaccine.
Biostatistics, Bioinformatics, & Epidemiology (BBE) is a research program within the Vaccine and Infectious Disease Division of the Fred Hutch. With the goal being to eliminate the mortality and morbidity of infectious diseases, members of the program conduct quantitative scientific research employing biostatistics, bioinformatics, computational biology, infectious disease epidemiology, and mathematical modeling. Members of the program collaborate extensively with laboratory and clinical science colleagues both within the Hutch and provide leadership for statistical data management centers and modeling consortia worldwide. The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) is part of BBE.
About SCHARP:
The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) provides statistical collaboration to infectious disease researchers around the world and conducts a complementary program of statistical methodology, and mathematical modeling research. SCHARP also collects, manages, and analyzes data from clinical trials and epidemiological studies dedicated to the elimination of infectious disease as a threat to human health. Current projects include studies to evaluate and implement prevention strategies for HIV, tuberculosis, polio, malaria and other global important pathogens.
Job Summary:
We are looking for an experienced, innovative and collaborative Manager to lead the SCHARP Laboratory Data Operations (LDO) Section. Part of the SCHARP Data Management Unit (DMU), the LDO team is responsible for developing and maintaining the laboratory assay and specimen data pipelines for multiple clinical trials, pre-clinical studies and research and development projects. Primary projects include managing lab data from studies implemented by the HIV Vaccine Trials Network (HVTN), HIV Prevention Trials Network (HPTN), Microbicides Trials Network (MTN), United States Military HIV Research Program (USMHRP), and the Collaboration for AIDS Vaccine Discovery (CAVD).
The Manager of SCHARP Lab Data Operations provides leadership to the section and collaborates with other SCHARP managers to develop organizational strategies that support our research goals. This includes development of policies, procedures and methods; oversight of data management staff; management of workflows, projects and resources; collaboration with other groups within SCHARP and with external research network partners. The LDO manager is expected to work under minimal supervision, communicate effectively with their staff and project teams, and be responsive to the needs of partner investigators to develop lab data pipelines that are efficient, standardized, documented and promote the maintenance of data integrity.
Responsibilities:
A. Leadership: The SCHARP Lab Data Operations Manager reports to the Data Management Unit (DMU) Head at SCHARP and is responsible for advising on section needs, progress, timelines, cooperating with senior leadership to manage conflicting lab data management priorities across research efforts.
B. Personnel & Project Management: The LDO Manager provides leadership to the section, overseeing a team of 10-15 programmers and data managers, managing workloads, priorities and performance. The LDO Manager is also expected to manage resources and oversee the production of deliverables for lab-data related projects and studies; this includes working with SCHARP teams and network laboratory investigators to define needs and developing plans to meet those needs.
C. Technical Guidance: The LDO Manager is expected to collaborate with internal and external Subject Matter Experts to provide technical vision and guidance on the development of infrastructure needed to support the overall data management for regulated Phase I/II/III clinical trials and the various R&D/pre-clinical study projects. This includes oversight of methods for lab data collection, QA, data processing/cleaning, generation of datasets and reports, and development of related SOPs and work instructions.
D. In support of study procedures, funding agency requirements, and organizational needs, the Manager of Lab Data Operations may perform some or all of the following tasks:
- Direct the section operations; work with LDO supervisors to provide organizational leadership, support collaboration and team building, facilitate cross-group interactions and projects, identify infrastructure and technological needs
- Provide training, direction and performance management for individual employees; manage workloads and priorities, support professional development, work with Fred Hutch Human Resources staff to facilitate recruiting efforts and staffing changes
- Serve as the section representative/advocate in Unit/cross-Unit/Management Team meetings and other high-level collaborations; communicate staff needs, provide transparency into section operations and assess impacts to section operations
- Foster collaboration with other SCHARP staff/teams (project/program managers, statistical staff, programmers, etc.) to achieve common goals; partner to solve complex problems, develop policies/procedures and share methods/resources
- Oversee the development and documentation of work practices; ensure methods meet applicable clinical trial regulations, confidentiality requirements and data management best practices while promoting standardization, efficiency and data quality; ensure work practices are well documented; support the development and maintenance documentation (SOPs, work instructions, policies)
- Manage section projects and resources; work with internal/ external partners to define project goals, resources, priorities; allocate and monitor effort/progress, redistribute or negotiate addition of resources as required; ensure deliverables are completed within timelines and stakeholders are informed and satisfied with project outcomes
- Lead infrastructure development/process improvement efforts; evaluate existing processes, keep abreast of current methods in lab data management, propose and implement advances/improvements as needed to increase efficiency and data integrity
- Other duties as assigned
Qualifications:
Minimum qualifications:
- Master's degree in Science, Public Health, Computer Science or similar degree in a scientific, technical or health-related field
- At least 3 years of direct staff supervision/management
- Project and/or program management training and/or experience
- At least 2 years of experience with clinical and/or lab data management
- Demonstrated leadership skills and excellent oral and written communication skills are essential
Preferred qualifications:
- Doctoral degree in biological or computational science field
- Technical experience in programming and/or data collection
- Experience managing complex teams/operations and contributing to high-level organizational strategic planning and decision-making
- Previous experience with laboratory assay development or data management, especially immunology, virology and/or pharmacology assays
- Familiarity with Good Clinical Data Management Practices and/or CDISC standards
- Experience with external data audits
- In-depth understanding of current/standard approaches to data collection, processing of raw data into analysis datasets, and other downstream research activities is highly desirable
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Please include a cover letter when applying for this position either as an additional attachment on your profile or merged into the file that contains your resume.
