Senior Clinical Supply Manager - Permanent - Boston, MA

Proclinical is seeking a dedicated and detail-oriented Senior Clinical Supply Manager. This is a permanent position located in Boston, MA.

Primary Responsibilities:

The successful candidate will be responsible for forecasting Investigational Product (IP) needs for individual trials, overseeing drug manufacturing operations, and ensuring adherence to regulatory requirements. This role involves coordinating with various teams and vendors, and ensuring uninterrupted supply of IP for study startups and depots.

Skills & Requirements:

• Bachelor's degree in a relevant scientific discipline or logistics field.
• Excellent interpersonal, analytical, presentation, problem-solving and communication skills.
• Ability to understand the needs and motivations of other team members and external collaborators.
• Detail-oriented with the ability to interact effectively with both internal and external customers at all levels.

The Senior Clinical Supply Manager will:

• Manage the Contract Manufacturing Organization (CMO) supply chain distribution.
• Oversee import and export activities and documentation for participating countries.
• Assist with temperature excursion documentation, review, and resolution.
• Coordinate with packaging and labeling vendors to ensure timely delivery of supplies.
• Assist in writing the pharmacy manual and reviewing compliance with regulatory requirements.
• Forecast future clinical supply needs and create supply strategies based on clinical protocols and enrollment rates.
• Establish and maintain the clinical supply production schedule.
• Coordinate kit numbering and randomization lists with biostatistics and packaging vendor.
• Monitor site and depot inventory levels and adjust IP shipments based on demand.
• Track study drug expiry dates to ensure timely re-supply.
• Assist drug packaging vendor with overall drug reconciliation at study end.
• Review budget of packaging vendors contracts.
• Perform other tasks as assigned by the supervisor.

If you are having difficulty in applying or if you have any questions, please contact Patrick Mooney at or p.mooney@proclinical.com .

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDCR