Senior Clinical Lab Study Manager

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.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Senior Clinical Lab Study Manager? This position is located in our King of Prussia PA, Marburg Germany, Maidenhead UK or Amsterdam office. It is a Hybrid role. You will have multiple direct reports. You will report to the Associate Director of Bioassay and Sample Management.

You will establish CSL’s laboratory management strategy, processes and standards, select and oversee central laboratory vendors and ensure compliant delivery within budget across global laboratory programs. You will manage laboratory teams and will work with the program directors, clinical teams and R&D teams offering scientific and strategic guidance.

You will support budget management, protocol development and feasibility activities, providing guidance where required. The L-BSM is also responsible for ensuring that all sample activities are conducted in accord to GCP, GCLP and to all relevant guidelines within a QA-regulated environment.

Responsibilities:

• Responsible for project managing the end to end clinical sample lifecycle including: Sample collection protocols and sample shipment from clinical/investigator sites/depots to external vendor 300+ sites across 15+ countries
• Ensuring central testing is being conducted according to the optimized, validated protocol(s), issue/risk identification and resolution; ensure escalation pathway to Snr/GTL and Program Director.
• Responsible for identifying, evaluating and selecting external vendors that can conduct central lab activities and sample testing to support important global clinical trials. Accountable for oversight of clinical samples vendors and ensuring quality of data is validated protocols.
• Manage clinical samples per country regulations and informed consent procedures. Capability to manage complex sample collection and shipping process across global regions (Asia Pacific, Americas (NA and LATAM) and Europe, Middle East and Africa).
• Review validation protocols for clinical testing and ensures testing is in compliance with clinical protocol, local regulations and Good Clinical Practice.
• In collaboration with Research and Technical Development serology functions guide optimization of assays and changes to testing procedures as requested by Regulatory Authorities.
• Provision of serology expertise in responding to Regulatory Agency questions regarding serology testing.

Qualifications:

• MS or equivalent in relevant immunology, medical, pharmacy, or other life-science discipline
• 6+ years’ relevant clinical research (or related) 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.

BENEFITS

• Medical, Dental Vision
• 401K
• Paid time Off

#LI-Hybrid

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.