Analyst, Clinical Drug Supply Systems - United States
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The Analyst in the Clinical Drug Supply group provides support to the Study Management Team in the overall management, implementation, and maintenance of IRT systems supporting our clinical trials. Key responsibilities include:
- Assisting in the creation of RFPs for IRT services and communicating specific study requirements to the vendors
- Working with Vendor Contract Managers to request IRT procurement and upgrade quotes from the IRT
- Collaborating with Clinical Development (e.g. Clinical Operations, Statistics, Data Management) and Clinical Drug Supply to capture and document study-specific requirements for the IRT systems
- Assisting in the development, maintenance and update of the baseline IRT standards
- Supporting the study team in managing IRT delivery timelines in conjunction with other key study milestones
- Creating and managing the overall User Acceptance Test (UAT) plan
- Overseeing UAT execution and coordinating activities with the IRT vendor and all testers
- Consolidating UAT results and working with IRT vendor on managing and prioritizing any UAT defects identified
- Providing support in the troubleshooting and resolution of issues in all phases of the IRT lifecycle
- Managing the retirement of the IRT system and archival of its data at study closure
- Participating in projects and initiatives to improve IRT functionality and the supporting processes
- The ideal candidate will have 2+ years experience in developing, managing and/or implementing IRT systems or other clinical systems.
- A background in clinical trials management, clinical systems or clinical supply chain management is necessary.
A BS is required.
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.