Job Description

Clinical Supply Operations Specialist - Contract - Basking Ridge, NJ

Ready to lead projects that bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!

Proclinical is seeking a Clinical Supply Operations Specialist to support the distribution process of Investigational Products (IP) and ancillary supplies across various therapeutic areas.

Primary Responsibilities:

The successful candidate will be involved in managing moderately complex studies, short-term projects, and continuous improvement initiatives. You will ensure activities are completed on time, within budget, and meet quality standards in compliance with regulatory guidelines.

Skills & Requirements:

• Understanding of clinical drug development and trial methodology
• Knowledge of ICH/GCP and regulatory guidelines
• Proficiency in MS Word and Excel
• Strong problem-solving and time management skills
• Ability to thrive in ambiguity and adapt to changes
• Excellent collaboration, communication, and organizational skills
• Detail-oriented approach
• Bachelor's Degree in a relevant field with experience in clinical supplies, QA/regulatory, precision medicine, supply chain, or manufacturing

The Clinical Supply Operations Specialist's responsibilities will be:

• Plan and manage IP supply and inventory
• Handle accountability, reconciliation, returns, and destruction processes
• Manage internal systems for lot creation, batch status, and inventory maintenance
• Conduct assessment and oversight activities, including risk management and trend analysis
• Coordinate IP shipments and depot transfers
• Manage temperature excursions and supply monitoring
• Document activities in the Electronic Trial Master File (eTMF)
• Create and manage expected document lists per regulatory requirements
• Oversee QA/QP release management and inspection readiness
• Reconcile pack-and-label kits and sequences
• Manage IRT activities, including alerts and user acceptance testing
• Support suspected serious non-compliance issues
• Plan and manage ancillary supply and inventory
• Provide procurement support and manage shipping logistics

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at [email protected]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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