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Clinical Trial Supply Study Manager
vor 1 Monat
For our Clinical Trial Supply department in Marburg, King of Prussia or Zurich, we are looking for a
Clinical Trial Supply Study Manager (m/f/x)
R-
Fulltime / permanent
The Clinical Trial Supply (CTS) Study Manager manages the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle. The CTS Study Manager independently leads clinical studies to ensure compliant supply of study medication and ancillary materials for our patients. The role includes determining kit design and blinding, forecasting demand of investigational product and ancillary supplies, establishing, and managing the depot network and distribution to clinical sites, and ensuring final return and destruction. The CTS Study Manager also leads process improvement projects for the clinical supply chain.
The role reports to Director, CTS Study Management.
The Opportunity
- Gives input and oversees the implementation of multi-year clinical supply strategies and plans for assigned simple to complex clinical studies.
- Lead demand forecasting for studies; use simulation and optimization tool capabilities to improve clinical trial supply plans and minimize the effect of inherent uncertainties. Specify ancillaries supplies with input from Clinical Development Operations, Clinical Science and Product Development; plans demand for centrally supplied materials.
- Presents IMP related CTS topics in Study Execution Teams. Determine labeling and clinical kit design based on protocol and countries' needs.
- Establish global network of regional depots and global depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies. Manage the inventory levels and product expiry. Ensure on time delivery of drug supplies and ancillary supplies from depots to clinical sites and patients.
- Trains external partners (i.e, clinical monitors, clinical site personnel) and internal global clinical study teams regarding IMP handling.
- Files proper documentation throughout the study and after study closure.
- Uses Interactive Response Technology (IRT) systems to ensure reliable and efficient clinical supply to depots and sites and Co-develops IRT specifications for drug supply management.
- Generates study specific Request for Proposals based on study assumptions, creates Purchase Orders, reviews and approves invoices.
- Ensures compliance of all clinical study activities with SOPs and regulations for assigned studies. Participate in GxP audits and regulatory inspections. Develop global and harmonized SOPs to assure ongoing quality, compliance, and efficient conduct of clinical supply activities.
- Creates and updates budgets for complex studies
- Identifies opportunities and establishes business cases for process improvement and new ideas on projects. Independently lead cross-functional process improvement and innovation projects for the clinical supply chain.
Your Skills and Experience
- University Degree as Bachelor of Science, e.g. in logistics or biology or equivalent experience
- More than 5 years of experience in clinical research and logistics in the biopharmaceutical industry, including at least 2 years of experience in clinical trial supplies management of global studies
- Extensive experience in global project management, ideally in the R&D area
- Knowledge and experience in GCP/cGMP/GDP/ICH including relevant standards, regulatory requirements and regulations related to clinical developments
- Fluent in German and English language
- Excellent presentation skills
What we offer
- Excellent income potential and extended benefits based on the collective agreement of the chemical industry Hesse (incl. Christmas and vacation allowance, voluntary bonus, and retirement plan) (Marburg)
- Up to two additional leave days for your personal wellbeing.
- By means of a long-term account, you can use accumulated overtime for sabbaticals, special leave, or an early start into retirement (Marburg)
- Family services such as psychological support, legal advice, family care services and more for you and your direct family
- Hybrid working model
For more information, please check out our global benefits below
We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.
Our BenefitsWe encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
About CSL BehringCSL 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.
We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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