Lab Data Manager I/II

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. SCHARP is a full service statistical and data management center focused on HIV prevention research. The Lab Data Manager I‑II will lead/oversee the setup and ongoing operational activities around the transfer and processing of data from external laboratories to the Lab Data Management (LDM) department in SCHARP. The role ensures that timelines, expectations and standard operating procedures for lab data management are met, and that study and protocol activities are supported under moderate supervision. Responsibilities Act as a representative to SCHARP study teams to ensure accurate CRF design for specimen collection and timely processing of study assay results. Act as a liaison between labs and statisticians and educate statisticians on the background of the assay methodology. Manage and perform specimen data and assay data quality check (QC) processes and pipelines. Distribute specimen data and assay data discrepancy reports. Lead/develop special reports to track and monitor network‑wide trends of information. Manage inbound data transfer pipelines from external laboratories into SCHARP. Lead/develop specifications for Lab Data Programming. Work closely with the Programming department to ensure the format, quality control and data reporting for specimen and assay data pipelines are implemented according to specifications. Lead user acceptance testing of pipeline implementation. Liaise with external laboratories to investigate and resolve data and reporting discrepancies and to standardize incoming data formats. Lead/develop Data Transfer Plans, Data Management Plans and other documentation associated with specimen and assay data transfers, data handling decisions and other procedures as indicated in LDM Standard Operating Procedures (SOPs) and Work Instructions (WIs). Coordinate and help disseminate data transfers to external partners. Update work in appropriate task trackers to ensure operational transparency. Create and maintain LDM documentation included in the Trial Master File (TMF). Support the Research Project Manager in the intake of requests for work, updates on work status and managing task tracking to provide operational transparency. Adhere to and contribute to quality assurance procedures, standard operating procedures, work instructions and work practice guidelines. Participate in and/or lead strategic projects that support development or improvement of processes described above. For Lab Data Manager II, assist in mentoring and training Lab Data Managers I and Lab Data Coordinators. Escalate issues to LDM management as appropriate. Contribute to ongoing development of SCHARP procedures and practices by participating in committees and working groups. Perform other duties as assigned. Qualifications Lab Data Manager I Bachelor’s degree in biological sciences or equivalent. 3 years of clinical or lab data management experience. Demonstrated ability to work independently and as part of a team. Demonstrated ability to manage projects and competing priorities. Demonstrated ability to effectively manage complex collaborations. Must be flexible, and capable of meeting tight deadlines. Must be organized and detail‑oriented, with excellent oral and written communication skills. Lab Data Manager II All minimum qualifications of Lab Data Manager I, plus: Minimum 4 years of clinical or lab data management experience (or an equivalent combination of education/experience). Preferred Qualifications Lab Data Manager I Experience translating business requirements into technical requirements. Experience creating specifications for programming teams. Familiarity with programming languages such as Python. Proven ability to work in databases and understand concepts of data format, key fields and variables and how quality checks and transformations change input data to output data. Lab Data Manager II Master’s degree in biological sciences or equivalent. Clinical research experience. Working knowledge of clinical trials regulations including ICH and GCP. Experience translating business requirements into technical requirements. Experience creating specifications for programming teams. Experience with Python. Salary Lab Data Manager I : $80,475 to $120,682 Lab Data Manager II : $88,712 to $133,058 Benefits and Eligibility Fred Hutchinson Cancer Center offers employees a comprehensive benefits package including 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). H‑1B sponsorship is not currently offered, but candidates already holding an H‑1B sponsored by another organization and currently in the United States may be eligible. Additional Information We are a proud 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, 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 you need assistance or a reasonable accommodation during the application or recruiting process due to a disability, please send a request to Human Resources at View email address on click.appcast.io or call View phone number on click.appcast.io. #J-18808-Ljbffr Fred Hutch