Senior Clinical Supplies Manager (Remote)

SENIOR CLINICAL SUPPLIES MANAGER (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 Clinical Supplies Manufacturing, 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 Client policies and procedures.

• Develops and implements the initial timeline, budget, drug supply forecasts and component requirements needed for preparation of the Clinical Supply Master Plan 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 GCSM at CMC/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.
• Role: 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.
• Role: Demonstrates a comprehensive understanding and is knowledgeable in regulatory requirements, including GMPs and Google Cloud Platforms-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.

• Minimum Requirements Bachelor's Degree.
• Minimum 3-5 year for Specialist role; or at least 6+ years for Sr. Specialist role 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.
• Ability to travel up to 10% of time.