Job Title: Trial Supplies ManagerLocation: 100% Remote - Summit, NJHours/Schedule: Mon-Fri, 8a-5pCompensation: $70/hr-$75/hrType: contract - 6 monthsJoule is currently recruiting for a Trial Supplies Manager to work for one of our largest pharmaceutical clients. The ideal candidate will have at least 2 years of experience and a strong knowledge of global drug development and global regulatory guidelines.This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4. The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study participants. Job Requirements:
2 years of relevant work experience required, preferably in a pharmaceutical environment.
Moderate / Strong knowledge of the global drug development process and global regulatory requirements.
Strong communication and negotiation skills.
Proficient and strong Project management skills.
Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e. Manufacturing, Packaging & Labelling, IRT, Logistics, Quality, Stability, etc.
Proficient knowledge of import / export requirements.
Proficient/Strong knowledge of IRT and CTMS systems.
Experience:
Working with teams for optimal use of the investigational material supply chain to achieve study and corporate goals.
Identifying and supporting strategies for continuous improvement and departmental and/or inter-departmental projects.
Co-creating clinical and development timelines and directly responsible for communicating timelines and investigational product strategies to Study Teams as well as cross-functional teams.
Proactively defining, planning, and communicating clinical supply strategy in support of global clinical studies, as well as monitoring and reacting to unforeseen clinical demand changes.
Developing supply forecasts through evaluation of the clinical development plan and protocol analysis.
Reviewing and providing input for draft medical protocols to develop packaging and labelling configurations and create packaging specifications in collaboration with Clinical Operations partners.
Collaborating with Global Clinical Supply Chain functions and external Vendors on the package design and label development for investigational product to meet all protocol and regulatory requirements.
Monitoring long-term inventory and allocation strategies considering drug recertification, country specific regulatory requirements, international drug shipment and overall demand.
Performing analytical assessments of drug utilization as it pertains to current forecasts versus inventories and creating product orders as needed.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.