Aktuelle Jobs im Zusammenhang mit Senior Manager, CTS Study Management - Marburg - CSL Behring
-
Senior Manager, CTS Study Management
vor 4 Monaten
Marburg, Deutschland CSL Behring VollzeitThe Opportunity: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...
-
Senior Manager, CTS Study Management
vor 6 Monaten
Marburg, Deutschland CSL Behring VollzeitThe Opportunity: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...
-
Senior Manager, CTS Study Management
vor 4 Monaten
Marburg, Deutschland CSL Behring VollzeitThe Opportunity: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...
-
Senior Manager, CTS Study Management
vor 6 Monaten
Marburg, Deutschland CSL Behring VollzeitThe Opportunity: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...
-
Senior Manager, CTS Study Management
vor 6 Monaten
Marburg, Deutschland CSL Behring VollzeitThe Opportunity: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...
-
Senior Manager, CTS Study Management
vor 4 Monaten
Marburg, HE, 35037, Marburg, Deutschland CSL Behring VollzeitThe Opportunity: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...
-
CTS Packaging
vor 4 Monaten
Marburg, Deutschland OSB AG VollzeitMake it happen YOU... are responsible for planning and coordinating the labeling, packaging, and release of investigational medicinal products (IMP) for global clinical programs, including Investigator Initiated Trials (IITs) ensure regulatory compliance in IMP label text translations and providing consultancy to CTS study teams on packaging manage...
-
Marburg an der Lahn, Hessen, Deutschland CSL Behring VollzeitJob Summary:We are seeking a highly skilled Senior Manager, Clinical Trial Supply Chain Management to join our team at CSL Behring. This is an exciting opportunity to lead the clinical supply chain for assigned studies, ensuring compliant, on-time supply of study medication and ancillary materials for our patients.Key Responsibilities:Gives input to and...
-
Senior Manager, Clinical Trial Supply Chain
vor 1 Monat
Marburg an der Lahn, Hessen, Deutschland CSL Behring VollzeitThe Opportunity:The Clinical Trial Supply Chain Senior Manager is responsible for overseeing the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle. This role independently leads clinical studies to ensure compliant, on-time supply of study medication and ancillary materials for our patients.Key...
-
Clinical Supply Chain Manager
vor 4 Wochen
Marburg an der Lahn, Hessen, Deutschland CSL Behring VollzeitClinical Supply Chain ManagerAt CSL Behring, we are seeking a highly motivated and experienced Clinical Supply Chain Manager to lead our global study management team. This is a unique opportunity to join our dynamic team and contribute to the development and delivery of high-quality medicines that treat people with rare and serious diseases.Job Summary:As a...
-
Senior Manager, R&D Quality
vor 6 Monaten
Marburg, Deutschland CSL VollzeitFor our R&D Quality Management in Marburg we are currently looking for a: Senior Manager, R&D Quality (m/f/d) – R-229349 (fulltime / unlimited / non-tariff Level 7/ Expiration Date: 07.05.2024) What you can expect: Manage integration of R&D quality systems, policies and procedures in line with CSL Global Quality Management System (QMS) for Product...
-
Senior Employee Relations Manager/in
vor 5 Monaten
Marburg, Deutschland CSL VollzeitFür unseren Bereich Human Resources in Marburg suchen wir aktuell eine/n Senior Employee Relations Manager/in (m/w/x) R-235152 Vollzeit / unbefristet / AT Sie fungieren als strategischer Partner für das CSL-Management und agieren als Mentor innerhalb des ER-Teams. Als solcher arbeiten Sie eng mit HR-Business Partnern, Managern, Mitarbeitenden,...
-
Senior Employee Relations Manager/in
vor 1 Monat
Marburg, Deutschland CSL Behring GmbH VollzeitCSL Behring ist ein weltweit führendes Unternehmen im Bereich Biotherapeutika, das sich dem Versprechen verschrieben hat, Leben zu retten. Wir konzentrieren uns darauf, die Bedürfnisse der Patienten durch den Einsatz modernster Technologien zu erfüllen, und entwickeln und liefern innovative Therapien zur Behandlung von Gerinnungsstörungen,...
-
Senior Employee Relations Manager/in
vor 3 Wochen
Marburg, Deutschland CSL Behring GmbH VollzeitCSL Behring ist ein weltweit führendes Unternehmen im Bereich Biotherapeutika, das sich dem Versprechen verschrieben hat, Leben zu retten. Wir konzentrieren uns darauf, die Bedürfnisse der Patienten durch den Einsatz modernster Technologien zu erfüllen, und entwickeln und liefern innovative Therapien zur Behandlung von Gerinnungsstörungen,...
-
Studienassistent in
vor 4 Wochen
Marburg an der Lahn, Deutschland Universität Marburg Vollzeit**Ausschreibungs-ID**: fb20-0234-studas-2024 **Eintrittstermin**: 01.01.2025 **Bewerbungsfrist**: 17.11.2024 **Entgeltgruppe**: bis E 9a TV-H **Befristung**: 4 Jahre **Umfang**: Vollzeit Die 1527 gegründete Philipps-Universität bietet vielfach ausgezeichnete Lehre für rund 22.000 Studierende und stellt sich mit exzellenter Forschung in der Breite der...
-
Senior Employee Relations Manager/in
vor 2 Monaten
Marburg, Deutschland CSL Behring VollzeitFür unseren Bereich Human Resources suchen wir aktuell eine/nSenior Employee Relations Manager/in (m/w/x) R-235152Vollzeit / unbefristet / ATSie fungieren als strategische/r Partner/in für das CSL-Management und agieren als Mentor/in innerhalb des ER-Teams. Als solche/r arbeiten Sie eng mit HR-Business Partnern, Managern, Mitarbeitenden, Rechts- und...
-
Senior Employee Relations Manager/in
vor 2 Monaten
Marburg, Deutschland CSL Behring VollzeitFür unseren Bereich Human Resources suchen wir aktuell eine/nSenior Employee Relations Manager/in (m/w/x) R-235152Vollzeit / unbefristet / ATSie fungieren als strategische/r Partner/in für das CSL-Management und agieren als Mentor/in innerhalb des ER-Teams. Als solche/r arbeiten Sie eng mit HR-Business Partnern, Managern, Mitarbeitenden, Rechts- und...
-
Senior Employee Relations Manager/in
vor 2 Monaten
Marburg, Deutschland CSL Behring VollzeitFür unseren Bereich Human Resources suchen wir aktuell eine/n Senior Employee Relations Manager/in (m/w/x) R-235152 Vollzeit / unbefristet / AT Sie fungieren als strategische/r Partner/in für das CSL-Management und agieren als Mentor/in innerhalb des ER-Teams. Als solche/r arbeiten Sie eng mit HR-Business Partnern, Managern, Mitarbeitenden, Rechts-...
-
Director, Clinical Portfolio Execution
vor 6 Monaten
Marburg, Deutschland CSL VollzeitDescription 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...
-
Senior Employee Relations Manager/in
Vor 2 Tagen
Marburg, Deutschland CSL Behring VollzeitFür unseren Bereich Human Resources suchen wir aktuell eine/nSenior Employee Relations Manager/in (m/w/x) R-235152Vollzeit / unbefristet / ATSie fungieren als strategische/r Partner/in für das CSL-Management und agieren als Mentor/in innerhalb des ER-Teams. Als solche/r arbeiten Sie eng mit HR-Business Partnern, Managern, Mitarbeitenden, Rechts- und...
Senior Manager, CTS Study Management
vor 1 Monat
The Opportunity:
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.
1. 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 based on protocol attributes and clinical assumptions. 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. Specifies ancillaries supplies with input from Clinical Development Operations, Clinical Science and Product Development; plans demand for centrally supplied materials.
2. 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.
3. 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. Ensures on-time delivery of drug supplies and ancillary supplies from depots to clinical sites and/or patients.
4. 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. Files proper documentation throughout the study and after study closure.
5. 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.
6. Generates study specific Request for Proposals based on study assumptions, creates Purchase Orders, reviews and approves invoices.
7. 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. Ensures Plateau SOP training is complete in time for self and staff.
8. 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. Supports budget creation on program level.
9. Ensures study reconciliation, returns, destructions are complete and leads lessons learned sessions.
10. 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.
11. Leads an improvement project team; may have direct reports; recommends hiring of candidates. Mentors junior staff.
- 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
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.
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
