Senior Specialist, Clinical Supply Chain (IRT/RTSM)
About The Position
Support Clinical Supply Chain activities, including but not limited to collaborating with internal stakeholders across Project Management, Clinical Operations, Quality Assurance, Regulatory Affairs, Technical Operations (Manufacturing and Analytical), Finance, and Legal, as well as external cGMP service providers. Key responsibilities include serving as the Clinical Supply Chain subject matter expert (SME) for the configuration and management of Interactive Response Technology (IRT) systems; providing guidance to internal and external users on IRT systems and procedures; troubleshooting system and operational issues; managing system enhancements; and developing procedures and policies as needed. The ideal candidate must have strong experience working with IRT providers and configuring IRT systems. The successful candidate will demonstrate strong organizational and project management skills, a thorough understanding of clinical study protocols, exceptional attention to detail, and an analytical, problem-solving mindset. Additional responsibilities include supporting broader Clinical Supply Chain activities, such as managing budgets, contracts, and invoices; coordinating clinical and stability drug packaging and distribution; and managing overall clinical supply logistics. The role will also collaborate with external vendors involved in the planning, packaging, distribution, storage, and destruction of Clinical Trial Materials (CTM).
Requirements
- Bachelor's degree supply chain, life sciences or related field AND 6+ years relevant experience in clinical supply chain, with a heavy experience working with IRTs, packaging and labeling and distribution
- Demonstrated success working with and managing third-party vendors.
- Strong understanding of cGMP supply chain
- In depth knowledge of IRT System development, implementation and maintenance
- Strong knowledge of clinical study tools (CTMS)
- Broad understanding of packaging/labeling requirements
- Ability to effectively work within a multidisciplinary team and manage multiple vendors
- Understands key clinical supply chain business drivers
- Has strong understanding of IRT processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas
- Proficient with tools and processes that support work conducted by functional area
- Ability to work as part of a team; may train lower levels
- Excellent computer skills, proficient in Microsoft Office programs
- Strong communications, problem-solving, analytical thinking skills
- Detail oriented yet can see broader picture for department
- Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
- Well-organized, detail-oriented with strong written and verbal communication skills
- Strong project management and interpersonal skills
- Self-starter working with a sense of urgency and acting as a team player
- Adaptability, flexibility, independence and resourcefulness with ability to work with changing timelines and willing to roll-up-sleeves in order to thrive in small company environment
Responsibilities
- Support establishment, management and maintenance of IRTs
- Serve as Clinical Supply Chain IRT SME in development and post system go-live
- Participate in development meetings with IRT vendor and Clinical Study Team
- Troubleshoot issues within IRT systems, addressing inquiries, investigating root causes and implementing appropriate solutions or escalation
- Issue RFQs, set up and manage contracts, budgets and billing with qualified IRT Vendors
- Support clinical studies in the planning and execution of drug product management activities
- Support development and review of Clinical Trial Materials (CTM) forecasts based on clinical trial study protocols
- Support packaging/labeling of CTM with approved cGMP vendors, based on approved demands, working with internal partners and systems, processing all drug dispositioning
- Support maintenance of CTM inventory working with vendors to ensure accuracy of inventory systems
- Other duties as assigned
Benefits
- retirement savings plan (with company match)
- paid vacation, holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Senior
