Clinical Trial Supply (CTS) Study Manager

CSL Behring; False Pass (AK); Hybrid; USD 90,000 - 130,000; Full time

Job summary

CSL Behring in Alaska offers a hybrid position with onsite work at posted locations, requiring a minimum of three days on site weekly to support clinical trial supply planning for low to medium complexity studies.

You will forecast drug volume, manage storage and distribution, engage external service providers, utilize IRT systems, and help author key study documents to ensure compliant, efficient supply chains.

Qualifications

• 5+ years of experience in clinical supply management in the pharmaceutical industry.
• Knowledge of ICH-GCP regulations and the conduct of clinical studies.
• Knowledge of cGMP and cGDP regulations.
• Strong interpersonal and communication skills.

Responsibilities

• Ensure efficient, cost-effective clinical trial supply planning and management for low to medium complexity studies
• Performs planning and forecasting of drug volume requirements
• Sample collection and analysis
• Ensures proper storage, transportation and archiving
• Assists with selection and management of external service providers in compliance with outsourcing strategy to ensure cost efficient and high quality services
• Leverages interactive response technology (IRT) system to support clinical supply management activities
• Authors/reviews critical study documents (e.g. study protocol, product dossiers, handling instructions, study reports)
• Leads or participates in global Clinical Trial Supply project meetings with internal and external team members
• Partners with R&D and other functions to ensure optimal use of systems and processes to support clinical trial supply chain
• Supports continuous improvements in clinical drug supply and revises SOPs to ensure ongoing compliance and efficient conduct of clinical trial supply activities

Skills

Clinical supply management

ICH-GCP knowledge

cGMP/cGDP knowledge

Team collaboration

Forecasting & planning

Education

Bachelor's degree in Life Sciences/Engineering/Logistics

Job description

Work Environment:

Hybrid position based onsite at any of the posted locations with a minimum of 3 days onsite weekly. Relocation and mobility assistance are not provided.

Main Responsibilities:

• Ensure efficient, cost-effective clinical trial supply planning and management for low to medium complexity studies
• Performs planning and forecasting of drug volume requirements
• Sample collection and analysis
• Ensures proper storage, transportation and archiving
• Assists with selection and management of external service providers in compliance with outsourcing strategy to ensure cost efficient and high quality services
• Leverages interactive response technology (IRT) system to support clinical supply management activities
• Authors/reviews critical study documents (e.g. study protocol, product dossiers, handling instructions, study reports)
• Leads or participates in global Clinical Trial Supply project meetings with internal and external team members
• Partners with R&D and other functions to ensure optimal use of systems and processes to support clinical trial supply chain
• Supports continuous improvements in clinical drug supply and revises SOPs to ensure ongoing compliance and efficient conduct of clinical trial supply activities

Minimum Qualifications:

• Bachelors Degree in Life Sciences, Engineering, Logistics or equivalent experience
• 5+ years of experience in clinical supply management with the pharmaceutical industry
• Demonstrated knowledge of ICH-GCP regulations and the conduct of clinical studies
• Demonstrated knowledge of cGMP and cGDP regulations
• Team-player with proven effective interpersonal and communication skills

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL (https://www.csl.com/careers/your-well-being) .

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer.

If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .

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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law.

CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.

https://www.cslbehring.com/careers/eeo-statement