Lab Data Manager I/II

Lab Data Manager I-II

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center 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 Lab Data Manager I-II to lead/oversee the setup and the ongoing operational activities around the transfer and processing of data from external laboratories to the Lab Data Management (LDM) department in SCHARP. Ensures that the timelines and expectations around data transfer and reporting are met and that standard operating procedures for lab data management are followed. The Lab Data Manager will manage or support study/protocols with moderate supervision from departmental leadership and will use independent judgement in making decisions regarding routine data management, quality control and data transfers.

The Lab Data Manager I-II will work independently and in a team environment and is expected to communicate effectively with internal staff and external collaborators with the goal of maintaining the integrity of assay and specimen data and improving the LDM team.

Most Fred Hutch jobs require some on-campus work. However, there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.

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 liaise/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

MINIMUM 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 the Lab Manager I Level, plus:

• Bachelor's degree in biological sciences or equivalent 4 years of clinical or lab data management experience OR an equivalent combination of education/experience will substitute for minimum qualifications.

PREFERRED QUALIFICATIONS:

Minimum Qualifications

Lab Data Manager I:

• Experience translating business requirements in 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 in technical requirements.
• Experience creating specifications for programming teams.
• Experience with Python.

Lab Data Manager I: The annual base salary range for this position is from $80,475 to $120,682, and pay offered will be based on experience and qualifications.

Lab Data Manager II: The annual base salary range for this position is from $88,712 to $133,058, and pay offered will be based on experience and qualifications.

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 View email address on click.appcast.io or by calling View phone number on click.appcast.io.