This person reports to the Director of Technical Operations and Clinical Supply Chain. This role will allow the ideal person to be exposed to new methodologies.
These may include, but are not limited to, the following; other duties may be assigned:
- Develop clinical study supply plans and maintain active inventory tracking for both clinical and placebo investigational drug products in compliance with company’s internal procedures and GxP requirements. Have experience and knowledge of executing Phase I – III protocols.
- Prepare clinical trial material forecasts at the study level and track material inventory, update use and expiry dating to ensure uninterrupted delivery of clinical study supplies. Proactively highlights to management when action is indicated. “Actions” may include a shelf life extension or resupply submission to health authorities are necessary.
- Have experience and thorough understanding of IXRS/IRT systems and trial execution using these systems.
- Participate in global clinical drug supply activities associated with the team’s trials (secondary packaging vendor selection, technical batch record review, QP Release coordination, clinical label design, packaging and labeling, IRT efficiencies)
- Vendor Management – Prioritize labelling and packaging activities at CROs/CMOs, when packaging operations for clinical trial material are in-process.
- Establish the packaging design based on protocol and manage all packaging activities including work order creation, review and approval of contractor packaging records and monitoring work at contractors
- Ability to coordinate CTM shipping and logistics activities including management of shipments of CTM from between storage/distribution sites and to clinical trial sites
- Ability to coordinate courier deliveries and shipments, and manage the courier relationship. Oversee packaging of materials according to IATA or DOT dangerous goods regulations. Oversee special projects including international shipments with awareness of required US Government certificate / license, if applicable, for worldwide shipment of investigational clinical trial material, drug substance, and drug product.
- Review temperature logs for CTM distribution and storage and investigates temperature deviations according to SOP
- Actively communicates supply plan progress to all stakeholders. Builds and maintains positive working relationships with co-workers and functional areas to accomplish project objectives.
- Participates on clinical sub-teams and provides clinical supply updates and summaries to management. Supports management with implementation of departmental strategies and policies.
- BS or Master’s Degree in life science, or related field (or equivalent experience)
- 8-10 years’ experience in GMP clinical supply chain, supply chain or pharmaceutical program management at a CRO and/or pharmaceutical/biotech organization.
- Preferably Certificate in Supply Chain Management Program
- Ability to work independently to make strategic decisions related to planning, and budgeting.
- Understanding of cGMP’s and pharmaceutical industry procedures and regulations
- Must have Clinical Supplies Packaging experience, distribution experience, supply chain and project management experience
- Hand on experience with Interactive Web Response System (IVRS/IWRS) clinical supply software
- Strong, open and transparent communication skills (verbal and written)
- Solid organizational and time management skills
- Project management skills and computer proficiency
- Experience with: MS Excel, Word
- Ability and willingness to travel 10% of the time (internationally and domestically)