Easter Seals Jobs

R-249180 Clinical Trial Supply Study Manager

The Opportunity

The Clinical Trial Supply (CTS) Study Manager manages the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle. The CTS Study Manager independently leads clinical studies to ensure compliant supply of study medication and ancillary materials for our patients. The role includes 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 Study Manager also leads process improvement projects for the clinical supply chain.

Role

• Give input and oversee the implementation of multi-year clinical supply strategies and plans for assigned simple to complex clinical studies.

• Lead demand forecasting for study(ies); use simulation and optimization tools capabilities to improve clinical trial supply plans and minimize the effect of inherent uncertainties. Specify ancillaries supplies with input from Clinical Development Operations, Clinical Science and Product Development; plans demand for centrally supplied materials.

• Presents IMP related CTS topics in Study Execution Teams. Determine labeling and clinical kit design based on protocol and countries' needs; implement pooling concepts in the study.

• Establish global network of regional depots and global depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies.

• Generates 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. Develop global and harmonized SOPs to assure ongoing quality, compliance, and efficient conduct of clinical supply activities.

• Creates and updates budgets for complex studies.

• Identifies opportunities and establishes business cases for process improvement and new ideas on projects. Independently lead process improvement and new ideas projects for the clinical supply chain.

• Leads an improvement project team; participate in hiring staff. Mentor junior staff.

Your Skills and Experience

Education

• University degree (BSc, MSc, PhD) in life sciences, engineering, logistics or equivalent experience.

Experience

Required

• 5+ years' experience in biopharmaceutical R&D or supply chain preferred and experience in clinical trial supplies.

• 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 written skills.

• Customer focus.

• Team orientation and intercultural competence.

Preferred

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 (https://www.cslbenefits.com/csl/candidates) 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 (https://www.cslbehring.com/our-company) .

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 (https://www.cslbehring.com/careers/diversity-and-inclusion) at CSL.

Do work that matters at CSL Behring!

R-249180

CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement