Manager, Clinical Laboratory Data Operations
About The Position
The Manager, Clinical Laboratory Data Operations (MCLDO) serves as the central liaison between the clinical laboratory, study teams, and external clients to ensure accurate data handling and efficient communication. This role oversees all aspects of clinical data management, including review and approval of Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS), configuration of study panels within ClinSpark EDC, and participation in study-related meetings and client calls. The MCLDO conducts data analyses to identify trends or shifts in assay performance, ensuring data integrity and quality. Additionally, the position manages operations of the Peripheral Blood Mononuclear Cell (PBMC) Laboratory and supports management in developing ELISA assays tailored to specific study protocols.
Requirements
- Bachelor’s degree in associated science field; Chemistry, Biology or other Physical science, preferred.
- Minimum 2 years of related laboratory experience (or, as required by location)
- 2 years supervisory experience in a Clinical Laboratory setting preferred (or, as required by location)
- None, current MLT/MLS (ASCP)cm preferred.
- MS Word, Excel, Outlook, Power Point, ClinSpark, CGM LabDaq, Math for Dilutions and ELISA workup.
- Ability to read and interpret technical documents and industry specific manuals.
- Ability to write advanced reports and correspondence.
- Ability to speak effectively before groups of customers or employees of the organization.
- Understanding of various basic lab assay nomenclature.
- Excellent verbal and written communication skills.
- Well-developed interpersonal skills are required.
- Personal/professional integrity and proven discretion in handling confidential information.
- Ability to develop strong trusting relationships to gain support and achieve results.
- Capable of managing multiple conflicting priorities.
- Must be self-directed, motivated, and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for implementation.
Nice To Haves
- Relevant industry experience a plus.
Responsibilities
- Serve as the primary point of contact for query resolution as it pertains to the clinical laboratory and data extracted within.
- Data transfer agreement (DTA) and data transfer specification (DTS) review and approval, if applicable for paper studies or external clients.
- Build panels on ClinSpark EDC in accordance with protocols.
- Interfacing with the study and project management teams.
- Data analysis to determine possible shifts and trends within assay specific results.
- The Peripheral Blood Mononuclear Cells (PBMC) Lab and its associated operation.
- Assisting management with building out and running Enzyme-Linked Immunosorbent Assay’s (ELISA) for protocol specific assays.
- Being available for all internal and external client calls as it pertains to data management and all processes within.
- Assisting in the Clinical Diagnostic Laboratory.
- Possibly providing direct supervision to a small team, including but not limited to: Task delegation, employee development, performance feedback, and support for workplace relations, depending on project scope and organizational needs.
Benefits
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Telework when applicable.
- Training & Development Programs
- Employee Referral Bonus Program
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
251-500 employees
