Senior CTS Study Manager

CSL Behring • King of Prussia, Montgomery County, United States • $200k - $250k / year • 3w ago

The Opportunity

The Clinical Trial Supply (CTS) Senior Study Manager manages 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, 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.

The Role

Give input to and oversee the implementation of multi-year clinical supply strategies and plans for assigned simple to complex clinical studies.
Gather and document requirements for clinical supplies based on protocol attributes and clinical assumptions. Influence the protocol design for clinical supply reliability and efficiency.
Lead demand forecasting for study(ies); use simulation and optimization tools capabilities to improve clinical supply plans and minimize the effect of inherent uncertainties; adjust plans monthly based on actual use and changes to clinical and supply assumptions; confirm supply plans.
Specify ancillary supplies with input from Clinical Development Operations, Clinical Science and Product Development; plan demand for centrally supplied materials.
Present IMP related CTS topics in Study Execution Teams, Clinical Development Teams and Product Development Expert Team/Chemistry, Manufacturing, and Controls Team.
Determine labeling and clinical kit design based on protocol and countries' needs; implement pooling concepts in the study.
Monitor global network of regional depots and global depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies.
Coordinate compliant importation and supply of drug supplies and ancillary supplies into regional depots and global depots. Manage the inventory levels and product expiry.
Ensure on-time delivery of drug supplies and ancillary supplies from depots to clinical sites and patients.
Develop 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).
Train external partners (i.e., clinical monitors, clinical site personnel) and internal global clinical study teams regarding IMP handling.
File proper documentation throughout the study and after study closure.
Use Interactive Response Technology (IRT) systems to ensure reliable and efficient clinical supply to depots and sites.
Co-develop IRT specifications for drug supply management, participate in user acceptance testing and monitor inventory levels and IRT resupply settings. Adjust system settings based on study progress and changes to clinical and supply assumptions.
Create study specific Request for Proposals based on study assumptions, create Purchase Orders, review, and approve invoices.
Ensure compliance of all clinical study activities with SOPs and regulations for assigned studies.
Participate in GxP audits and regulatory inspections as needed.
Investigate deviations, product technical complaints and temperature excursions (site and transport) in collaboration with CSQ.
Develop global and harmonized SOPs to assure ongoing quality, compliance and efficient conduct of clinical supply activities.
Ensure Plateau SOP training is complete in time for self and staff.
Maintain 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.
Monitor study budget and provide reasons for variances. Process accruals.
Support budget creation on program level.
Ensure study reconciliation, returns, destructions are complete and lead lessons learned sessions.
Identify opportunities and establish business cases for process improvement and innovation projects. Independently participate in process improvement and innovation projects for the clinical supply chain.
Lead an improvement project team; may have direct reports; recommend hiring of candidates. Mentor junior staff.

Your Skills & Experience

University degree (BSc, MSc, PhD) in life sciences, engineering, logistics or equivalent experience.
7+ years' experience in biopharmaceutical R&D or supply chain including 4 years' experience in clinical trial supplies leading global studies.

Required Skills

Experience with global clinical trial and clinical supply chain processes.
Experience in GCP/GMP/GDP principles including relevant international standards and regulatory requirements related to clinical development.
Excellent English language ability.
Demonstrated flexibility.
Customer focus.
Team orientation and intercultural competence.
Analytical and problem-solving skills.

Preferred Skills

German language skills.

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