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Senior Clinical Supplies Management Specialist
Ref No.: 18-06880
Location: Madison, New Jersey
Position Type:Contract
Start Date / End Date: 07/02/2018 to 07/01/2019
Sunrise System Inc. is currently looking for Senior Clinical Supplies Management Specialist in Madison, NJ with one of our top client.
Job Title: Senior Clinical Supplies Management Specialist
Job Id: 18-06880
Location: Madison, NJ 07940
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Desired Skills
  • 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. 
Key Duties / Responsibilities Role
  • 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.
  • 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 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 Minimum Requirements Bachelor’s Degree At least 6+ years of Clinical Supply / Clinical Packaging / Project Management 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 
Contact
Vishal Tejaswi
Desk:732-3725-0312 | Email: vishal.t@sunrisesys.com
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com