Clinical Trial Supply (CTS) Study Manager

CSL Plasma•Emea, DE

5d•Hybrid

About The Position

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/ .

Requirements

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

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