Lab Data Manager I/II

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.
• 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).
• Cook up and help disseminate data transfers to external partners.
• 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.

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.

Pay

• 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.