Senior Manager, CTS Study Management
vor 6 Monaten
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.
Responsibilities:
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.
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
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 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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