Quality - Trial Supplies Manager

Mindlance; Lawrence Township (NJ); Remote; USD 70,000 - 90,000; Full time

Job summary

A global clinical supply chain firm is seeking a Supply Planner for a remote role in New Jersey. The candidate will manage inventory for clinical supplies, collaborate with multiple departments, and develop supply strategies to support clinical research phases. A Bachelor’s degree and relevant experience are required.

Qualifications

• 2 years of relevant work experience in a pharmaceutical environment.
• Experience in supply planning and inventory management.
• Strong analytical skills required.

Responsibilities

• Responsible for supply planning and inventory management of clinical supplies.
• Collaborate with cross-functional teams to ensure timely delivery of supplies.
• Develop supply forecasts and monitor inventory strategies.

Skills

Analytical Assessment

Collaboration

Supply Chain Management

Education

Bachelor's degree

Job description

Job Description: This is a remote role!
Shift Timing- EST Hours


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.
• Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO’s, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
• 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.
• Working with third party vendors to ensure the timely, efficient, high quality, cost effective execution of all outsourced clinical supply activities.
• Ensuring releasable supplies for all assigned compounds and Protocols considering country Regulatory and QP Release documentation and requirements.
• Initiating, reviewing and approving IRT specifications. Participating in user acceptance testing.
• Developing investigational product distribution strategies maintaining distribution and supply strategy at depot and site level according to study (and IRT) requirements.
• Actively participating in Trial Supplies Management Functional team, Study Team, Country Medical Affairs Affiliate & CSC Matrix Team Meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation required.
• Actively supports the CSC Budget Process.


Other Qualifications:
• Bachelor’s degree required.
• 2 years of relevant work experience required, preferably in a pharmaceutical environment.
• An equivalent combination of education and experience may substitute.
As a key partner to many functions within the clinical supply chain and the broader research and development business this opportunity provides access to a wealth of learning and development possibilities within the pharmaceutical business.
Additional Job Requirements:
None

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”