Manager, Clinical Supply Chain Management
The role will partner closely with Clinical Operations to oversee clinical supply packaging, labeling, storage, and distribution associated with clinical trial material (CTM). The manager, Clinical Supply Chain Management will successfully manage these activities in conjunction with AD, Clinical Supply Chain Management, Quality Assurance, and Pliant third-party service providers to ensure that clinical supply is available to meet trial demand. Responsibilities further include preparing metrics and monitoring operational performance across the clinical supply chain.
- Manage daily order intake and distribution activities with all third-party service providers, ensuring right first-time order submission and on-time delivery to clinics.
- Support clinical study management team demand planning, distribution, inventory management, and execution of packaging and labeling operations at third-party service providers.
- Serve as single point of contact for all clinical trial distribution activities throughout the duration of an assigned study.
- Provide a responsive, effective and high level of customer service to Pliant’s Clinical Operations team.
- Author policies and procedures required for clinical supply chain activities to ensure cGMP compliance.
- Support selection, configuration, URS/UAT, and management of clinical trial management E-Systems, IRT systems, etc.
- Proactively identify potential shipment delays and take action to mitigate as needed.
- Perform root cause analysis associated with supply disruptions, including but not limited to transit delays, temperature excursions, etc.
- Assist in compliance with custom and trade requirement for global shipments.
- Compile and route Label Copy Approval Forms.
- Select and establish INCO terms, FDA product codes and HTS codes.
- Create shipment documents (proforma invoices, End Use Letters, USDA Letters).
- Track and ensure import applications and permits are up to date.
- Participate in cross-functional distribution related projects and process improvement initiatives.
- Remain current with industry trends and best practices as well as changes in the regulatory landscape related to clinical supply chain.
- Strong working knowledge of clinical trial demand forecasting and distribution supply strategy.
- Direct experience interfacing with clinical IRT systems; experience implementing a clinical IRT system preferred.
- Demonstrated experience identifying, onboarding and managing third-party service providers.
- Strong working knowledge of clinical packaging and labeling operations, as well as associated quality and regulatory requirements.
- Knowledge of import/export requirements associated with clinical product to ex-U.S. locations preferred.
- Candidates must be authorized to work in the U.S.
- 3 to 5 years of relevant experience with an MS degree or 5 to 7 years of relevant experience with a BS/BA or 8+ years relevant experience with an AS degree including prior experience in clinical supply chain management.
- Degree in Business, Supply Chain Operations, or engineering field strongly preferred, but not required.
- Knowledge of cGMP quality systems.
- Understanding of drug product CMC activities.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.