Our client is looking to fill the role of Sr. Manager of Clinical Supplies Planning and Logistics. This Contract, Associate Director Clinical Supplies role is responsible for forecasting Investigational Product supply requirements, managing packaging, labeling, and distribution through 3rd party vendors, for one or more clinical trials.
Responsibilities:
- IP supply planning and logistics: Ensure alignment with study plans, timelines, budget, and clinical development plan.
- IP vendors: Manage vendors performance, quality, timelines, results, and costs. Contractor will review RFP and IP services vendors budgets.
- External Partners including CMOs, CROs, Vendors (Shipping & IRT), Study Sites
- Clinical Supply & Logistics: Demand forecasting and supply planning, IRT start-up through study closure, label generation and approval, packaging and labeling operations, release and distribution, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
- Work and collaborate with internal teams:
- Quality Assurance to ensure compliance around IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules.
- Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations
- Assists the design and review of IP-related study documents (pharmacy manual, IP section of protocol) and training materials
- Provide support to inspection team to prepare for regulatory agency inspection
- Ensures documentation of IP supply activities for TMF
- Provides input to drug kit randomization specifications and reviews and master kit lists
- Up to 10% Travel
Required Qualifications:
- Bachelors degree required
- Min. 8 years of industry experience within pharma or biotech. Prior small biotech preferred.
- Min. 5 years in clinical supply management
- Experience in small molecules clinical supply planning and logistics for multi-center, blinded global studies required
- Experience in IP logistics in APAC
- Knowledge of cGMP, GCP, GDP
- Experience in forecasting, labeling, and distribution in clinical environment
- Phase one study experience (FIH, Single Center, etc.) preferred.
- Understanding and proven experience in IRT/RTSM
- Clinical Supply and similar vendor management experience
- Knowledge of import/export policies
If you meet the required qualifications and are interested in this role, please apply today.
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Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn .
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