Job Description

CLINICAL SUPPLIES MANAGER (REMOTE) IRVINE, CA

THIS POSITION IS REMOTE. PROJECT DESCRIPTION:

• Independently coordinates clinical supply activities for clinical studies in support of development programs.
• These activities include review of clinical study protocols, design of clinical labels, preparation of packaging and labelling contracts, and forecasting and ordering supplies.
• Must coordinate the efforts of Clinical Trial Supplies Packaging with Drug Supply Management, Clinical Research, Pharmaceutical Development, Quality Assurance, and Regulatory Affairs with the objective of establishing a plan to have clinical supplies available within the agreed time frame.
• The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all the Client's policies and procedures.
• Develops and implements the initial timeline, budget, drug supply forecasts and component requirements needed for preparation of the Investigational Medicinal Product Supply Agreement for Phase I through IV clinical protocols Oversight: No oversight.
• Effectively organizes and conducts meetings and demonstrates facilitation and listening skills.
• Consistently demonstrates skills for evaluating customer needs and offering alternatives to accomplish project goals.
• Represent CDSM at Clinical meetings to update and forecast the status of projects.
• Reviews Clinical Research Development programs and coordinates development of yearly clinical supplies forecasts and supply plans.
• Protocol interpretation and breakdown.
• Demonstrates planning, project management, negotiation, and presentation skills.
• Monitor IP for duration of study and ensuring appropriate stock levels are available for study requirements.
• Continue to monitor budget, depots and monitor IRT after study start. Ensure IP reconciliation is completed.
• Works on routine assignments and applies knowledge and experience in learning new procedures.
• Report and Protocol Writing: Create reports and documents to facilitate and record every aspect of the operations performed or projected.
• Effective coordination of supply requirements for local and international studies, including continuous forecasting, communicating manufacturing needs, and scheduling of packaging/labelling activities.
• Demonstrates a comprehensive understanding and knowledge of the Investigational Product Supply Chain.
• Ability to handle multiple assignments and priorities simultaneously in a fluid environment with time pressures.
• Demonstrates a comprehensive understanding and is knowledgeable in development of Clinical Supplies IRT requirements for drug supply management.
• Sound judgement, analytical, problem solving and decision-making skills.
• Demonstrates a comprehensive understanding and is knowledgeable in regulatory requirements, including GMPs and GCPs.
• Review and update existing SOPs and identify the need for and assist in the establishment of new departmental procedures.
• Demonstrates a comprehensive understanding of the drug development process and requirements of IND/NDA submissions.

REQUIRED SKILLS:

• Bachelor's Degree.
• At least 6+ years of Clinical Supply / Clinical Packaging / Project Coordination experience in the pharmaceutical/device industry or CRO.
• Knowledge cGMPs and relevant FDA Regulations essential.
• Excellent communication and writing skills.
• Proficiency in Microsoft Office and Microsoft Project.
• High level of professionalism.
• Ability to prioritize, planning and problem-solving.
• Ability to handle multiple projects and work in a team environment.
• Ability to operate, with composure and confidence, in a team or matrix environment.
• Effective influencing skills.

This 12+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com ALPHA'S REQUIREMENT #21-03176 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR LI-BB1