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Senior Clinical Laboratory Manager

2 months ago

King of Prussia, Pennsylvania, United States CSL Behring Full time
About the Role

Career Opportunities at CSL Behring

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

We are seeking a highly skilled and experienced Senior Clinical Laboratory Manager to join our team. As a key member of our laboratory operations team, you will be responsible for establishing and maintaining laboratory management strategies, processes, and standards. You will oversee central laboratory vendors and ensure compliant delivery within budget across global laboratory programs.

Key Responsibilities:

  • Project manage the end-to-end clinical sample lifecycle, including sample collection protocols and sample shipment from clinical/investigator sites/depots to external vendor sites across multiple countries.
  • Ensure central testing is conducted according to optimized, validated protocols, and identify and resolve issues and risks. Escalate to Senior/GTL and Program Director as necessary.
  • Select and oversee external vendors that can conduct central lab activities and sample testing to support global clinical trials. Ensure quality of data and validated protocols.
  • Manage clinical samples per country regulations and informed consent procedures. Manage complex sample collection and shipping processes across global regions.
  • Review validation protocols for clinical testing and ensure compliance with clinical protocol, local regulations, and Good Clinical Practice.
  • Collaborate with Research and Technical Development serology functions to guide optimization of assays and changes to testing procedures as requested by Regulatory Authorities.
  • Provide serology expertise in responding to Regulatory Agency questions regarding serology testing.

Requirements:

  • Master's degree or equivalent in a relevant immunology, medical, pharmacy, or other life-science discipline.
  • 6+ years of relevant clinical research experience within the pharmaceutical industry.
  • Experience overseeing global vendors supporting clinical trials, sample testing, and sample logistics and storage.
  • Experience with project management software packages.
  • Knowledge of ICH, GCP, and GCLP guidelines.

What We Offer:

  • Medical, Dental, and Vision benefits.
  • 401K plan.
  • Paid time off.