Employment Spot

Job Description

CLINICAL SUPPLIES MANAGER

COMPANY INFO:
MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.

Our client contributes to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide and is seeking to add a Manager, Clinical Supplies to their team in Fort Lee NJ.

RESPONSIBILITIES:
•    Plans, establishes, manages and monitors activities related to clinical supplies to support the drug development process (Phase I-IV), in cooperation with internal and external customers and partners in compliance with multinational regulations as well as company internal procedures and GxP requirements.
•    Lead role in responsibility for complex studies requiring project management, IVRS, distribution, supply logistics and medication management.
•    Performs functional activities of Clinical Supply Manager and performs project management activities from a clinical supplies perspective.
•    Leads the planning, creation and maintenance of project plans, based on study forecasts.
•    Accountable for the scheduling and timely delivery of packaged clinical trial material, study design including randomization and the packaging, labeling and international distribution of clinical supplies.
•    Ensures that key project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners.
•    Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects.
•    Performs supply forecast simulations to determine optimal supply quantities and manufacturing/packaging campaigns, contributes to the design specifications for IVRS studies, and provides medication management for highly complex studies using IVRS and advanced supply allocation algorithms.
•    Maintains DSM project specific budget and provides input to department budgets.

Job Requirements

•    Degree in scientific or relevant discipline (BS or equivalent).
•    At least 5 years of relevant experience in Pharmaceutical Development, Clinical Development, Clinical Study Operations or Project Management.
•    Excellent organization and planning skills.
•    Good leadership skills.
•    Excellent communication, negotiation and interpersonal skills.
•    Ability to strategically plan, organize and manage multiple projects simultaneously.
•    Recognized expertise in managing functional activities associated with complex clinical supply chains including planning/forecasting, analytical/stability, manufacturing, and distribution of clinical supplies.
•    Successfully demonstrated track record of creativity and problem solving in projects.
•    Demonstrates working knowledge of clinical supply systems and specialized tools.
•    Advanced knowledge of development activities and processes.
•    Advanced project management skills.
•    Ability to work in interdisciplinary teams.
•    Strong knowledge of relevant GxPs as well as applicable multinational regulations.

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.