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- Aufgaben: Lead the supply chain for clinical studies, ensuring timely delivery of medications and materials.
- Arbeitgeber: CSL Behring is a global leader in high-quality medicines for rare diseases.
- Mitarbeitervorteile: Prioritize your well-being with our supportive work culture and diverse environment.
- Warum dieser Job: Join a mission-driven team making a real impact on patients' lives worldwide.
- Gewünschte Qualifikationen: Requires a degree in life sciences or logistics and 7 years of relevant experience.
- Andere Informationen: Fluency in German and English is essential; strong project management skills are a must.
Das voraussichtliche Gehalt liegt zwischen 72000 - 84000 € pro Jahr.
For our Global Supply Chain Department (Clinical Trial Supply) in Marburg we are currently looking for a
Senior Study Manager (m/f/x) – Clinical Trial Supply
R-249007
Fulltime / Permanent
The Clinical Trial Supply (CTS) Senior Study Manager is responsible for managing the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle. The CTS Senior Study Manager independently leads clinical studies to ensure compliant, on-time supply of study medication and ancillary materials for our patients. Responsibilities include 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 Senior Study Manager also leads process improvement projects for the clinical supply chain and may have direct reports.
Tasks & Responsibilities:
- Gives input to and oversees the implementation and execution of multi-year clinical supply strategies and plans for assigned simple to complex clinical studies. Gathers and documents requirements for clinical supplies. Influences the protocol design for clinical supply reliability and efficiency. Leads demand forecasting for study(ies); leverages simulation and optimization tools capabilities to optimize clinical supply plans and minimize the effect of inherent uncertainties; adjusts plans monthly based on actual consumption and changes to clinical and/or supply assumptions; confirms supply plans
- Presents IMP related CTS topics in Study Execution Teams, Clinical Development Teams and Product Development Expert Team/Chemistry, Manufacturing, & Controls Team. Determines labelling and clinical kit design based on protocol and countries’ needs; implements pooling concepts in the study
- Establishes and monitors global network of regional and global depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies. Coordinates timely and compliant importation and supply of drug supplies and ancillary supplies into regional and global depots. Manages the inventory levels and product expiry
- Develops clinical trial supply documents and training to support study execution for clinical sites and patients (e.g. Investigational Medicinal Product (IMP) Manuals, product preparation and administration videos). Trains external stakeholders (i.e,. clinical monitors, clinical site personnel) and internal global clinical study teams regarding IMP handling
- Utilizes Interactive Response Technology (IRT) systems to ensure reliable and efficient clinical supply to depots and sites. Co-develops IRT specifications for drug supply management, participates in user acceptance testing and establishes and monitors inventory levels and IRT resupply settings. Adjusts system settings based on study progress and changes to clinical and/or supply assumptions
- Generates study specific Request for Proposals based on study assumptions
- Ensures compliance of all clinical study activities with SOPs and regulations for assigned studies. Participates in GxP audits and regulatory inspections as needed. Investigates deviations, product technical complaints and temperature excursions (site and transport) in collaboration with CSQ. Develops global and harmonized SOPs to assure ongoing quality, compliance and efficient conduct of clinical supply activities.
- Creates and updates budgets for complex studies including product and packaging and labeling costs, storage and distribution costs, and comparator and ancillary material costs for assigned clinical studies. Monitors study budget and provide reasons for variances. Processes accruals as needed
- Identifies opportunities and establishes business cases for process improvement and innovation projects. Independently leads or participates in cross-functional process improvement and innovation projects for the clinical supply chain
Education & Requirements:
- University degree (BSc, MSc, PhD) in life sciences, engineering, logistics or equivalent experience
- Minimum of 7 years\‘ experience in biopharmaceutical R&D or supply chain including 4 years’
- Experience in clinical trial supplies leading global studies
- Strong project management skills paired with good communication skills in cross functional project teams
- Fluently speaking in German and English
Our Benefits
We 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 Behring
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.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
CSL Behring | Senior Manager (m/f/x) - CTS Study Management Arbeitgeber: CSL Behring
Kontaktperson:
CSL Behring HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: CSL Behring | Senior Manager (m/f/x) - CTS Study Management
✨Tip Number 1
Familiarize yourself with the specific requirements of clinical trial supply management. Understanding the nuances of kit design, demand forecasting, and inventory management will give you a significant edge in discussions during the interview.
✨Tip Number 2
Highlight your experience with Interactive Response Technology (IRT) systems. Being able to discuss how you've utilized these systems in past roles can demonstrate your technical proficiency and readiness for the position.
✨Tip Number 3
Prepare to discuss your project management skills in detail. Be ready to share examples of how you've successfully led cross-functional teams and managed complex projects, as this is crucial for the Senior Study Manager role.
✨Tip Number 4
Research CSL Behring's recent projects and initiatives in clinical trial supply. Showing that you are informed about the company's work and values can help you stand out as a candidate who is genuinely interested in contributing to their mission.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: CSL Behring | Senior Manager (m/f/x) - CTS Study Management
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Study Manager position. Understand the key responsibilities and required skills, such as project management and experience in clinical trial supplies.
Tailor Your CV: Customize your CV to highlight relevant experience in biopharmaceutical R&D and supply chain management. Emphasize your project management skills and any specific achievements related to clinical trials.
Craft a Compelling Cover Letter: Write a cover letter that connects your background with the requirements of the role. Mention your fluency in German and English, and provide examples of how you've successfully managed clinical supply chains in the past.
Highlight Process Improvement Experience: Since the role involves leading process improvement projects, be sure to include any relevant experiences where you identified opportunities for innovation and successfully implemented changes in previous roles.
Wie du dich auf ein Vorstellungsgespräch bei CSL Behring vorbereitest
✨Understand the Clinical Supply Chain
Make sure you have a solid grasp of the end-to-end clinical supply chain process. Be prepared to discuss how you would manage the supply of study medication and ancillary materials, as well as your experience with demand forecasting and inventory management.
✨Showcase Your Project Management Skills
Highlight your project management experience, especially in leading global studies. Be ready to provide examples of how you've successfully managed complex projects, including any challenges you faced and how you overcame them.
✨Demonstrate Your Communication Abilities
Since this role involves working with cross-functional teams, emphasize your communication skills. Prepare to discuss how you have effectively collaborated with various stakeholders, including clinical monitors and site personnel.
✨Prepare for Technical Questions
Expect technical questions related to Interactive Response Technology (IRT) systems and compliance with SOPs and regulations. Brush up on your knowledge of these areas and be ready to explain how you've utilized them in past roles.
