Job Description

Our client is looking to fill the role of Sr. Manager of Clinical Supplies Planning and Logistics. This Contract, Senior Manager Clinical Supplies Planning & Logistics 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. 6 years of industry experience within pharma or biotech. Prior small biotech preferred.
• Min. 3 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.

Clinical Resource Network Distinction

CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.

About CRN

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 .

Opportunity Awaits.

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