Job Description

Position: Clinical Laboratory Informatics Manager

FLSA Status: Exempt

Location: Onsite (Baltimore, Maryland)

Salary: $80,000 to $105,000

Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit

Job Overview

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.

Responsibilities

Management of Laboratory Data:

• 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.

Specimen Label Management:

• 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.

System and Instrument Validations:

• 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.

Quality Control:

• 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.

Laboratory Information Management Systems:

• 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.

What We're Looking For

We're seeking individuals who have strong communication skills with attention to detail and who thrive in fast-paced environments.

• 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.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centred" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits

As part of our commitment to your well-being, we offer a comprehensive benefits package:

• 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

How to Apply

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affidative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

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