Clinical Supply Consulting is currently seeking a Senior Clinical Supply Manager to partner with study teams, vendors, and various internal and external stakeholders to ensure the delivery and execution of a clinical supply plan that supports study protocols and timelines. From Manufacturing, Packaging, and Labeling, to Distribution and Technology Vendors, Clinical Supply Consulting partners with teams to optimize efforts, better anticipate resource and expenditure needs, and provide in-depth IRT and Clinical Supplies training, support, and planning services.
Responsibilities:- Manage the provision of all clinical supplies including finished product packaging and labeling, distribution, drug returns, and accountability, and coordinate with internal and external stakeholders as necessary
- Effectively manage projects on time and within budget
- Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategy
- Coordinate the origination, proofing, and translation of clinical study labels, as required
Define supply chain management accountabilities based on communication with customers, scope of work, and study requirements.
Selection and management of vendors for the supply of centralized services such as clinical trial supply companies, specialty labs, central suppliers
Oversee vendors from start-up to close-out including budget negotiation process and finalization, and ensure study budgets are managed to plan and scope
Ensure consistency of processes and documentation across multiple studies
Work collaboratively with other departments for the creation and approval of product labeling and import/export logistics
Track and manage temperature data associated with shipments of clinical drug supplies
Development of SOPs, RFIs, and RFI’s and other documentation as required
Evaluation of tools to support outsourcing oversight and study processes and Comparator sourcing
Skills & Experience:- 5+ years of experience in Clinical Supply Chain Management
- The ability to travel up to 10% of the time
- Top-notch verbal and written communication skills
- A passion for customer service and prior experience working in a customer-facing role
- Ability to manage multiple projects simultaneously
- Prior experience working with IRT or other software systems related to Clinical SuppliesGMP/GCP knowledge
- Advanced Excel skills
- What are the perks?
- Generous paid time off
- Comprehensive benefits package 401(k) with company match
- Friendly, smart, passionate and hard-working coworkers
- Opportunities for professional growth and advancement
