Clinical Trial Supply Senior Study Manager

2 weeks ago

King of Prussia Pennsylvania, Montgomery County, PA, United States CSL Behring Full time
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 documents 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.
  • Specifies ancillaries supplies with input from Clinical Development Operations, Clinical Science and Product Development; plans 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.
  • Files 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-develops IRT specifications for drug supply management, participates in user acceptance testing and monitors 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, creates Purchase Orders, reviews, and approves 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 and regulatory regulations 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

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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