Clinical Laboratory Informatics Manager

Pharmaron • Baltimore, MD

5d • $80,000 - $105,000 • Onsite

About The Position

The Laboratory Informatics Manager will be responsible for overall management of laboratory data, information systems and maintenance of instruments. This onsite role will manage all external laboratory vendors, program test panels for each study and ensure data transfer agreements with external vendors are fully executed prior to sample shipments.

Requirements

• BS in related field and 3 years industry experience.
• Knowledge of GLP GCP and FDA regulations.
• MLT/MLS/MT and LabDAQ/ClinSpark experience.
• Experience working with external sponsors and internally with laboratory, clinical, data and PM staff.

Responsibilities

• Ensure a unique code is assigned to identify each specific laboratory test.
• Integrate laboratory data from external vendors into Pharmaron CPC LIS.
• Prepare a cumulative laboratory data export file in accordance with the sponsor's requirements and timelines.
• Create reports and summaries of laboratory data for safety meetings and at each scheduled database lock (interim and final).
• Ensure laboratory data, database change documentation, and validation records are archived.
• Prepare specimen labels according to the requirements outlined in the IRB approved protocol and lab manual.
• Ensure the study sponsor provides written approval of all specimen label templates prior to study initiation.
• Upon written request from the laboratory staff, print specimen labels for each visit/timepoint and delivery to Laboratory Quality Control Associate.
• Ensure written request for label destruction is received, prior to execution.
• Ensure all laboratory systems are validated initially and each time updates are incorporated.
• Ensure all clinical laboratory equipment is validated to verify the instrument performs.
• Daily quality control review of all laboratory reports prior to being released to the PI/sub-investigator for review and assessment.
• Perform the initial QC view of the data export file from external lab-vendors.
• Organize and perform on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, discrepancies, and quality issues.
• Integrate new and existing laboratory instruments into the LIMS system.
• Work with LIMS developers and instrument manufacturers to resolve difficulties during the integration process.
• Create rule sets for the handling, cleaning, and analysis of lab data.
• Review audit logs and raw HL7 data to troubleshoot data related problems.

Benefits

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees