Clinical Trial Supplies Manager

This range is provided by Dexian. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$75.00/hr - $80.00/hr

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Job Title:
Clinical Trial Supplies Manager

Location: 100% Remote

Duration: 06 Month(s) Contract

Pay Range: $75-$80/hr (without any benefits)

Job Description:

Top Skills:

• Proficient/Strong knowledge of SAP

• Minimum 5+ years Pharma Industry related experience

• Minimum 3 years Clinical Supplies/Development with global experience or equivalent experience.

• Proficient/Strong knowledge of SAP, IRT and CTMS systems.

• Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e. Manufacturing, Packaging & Labelling, IRT, Logistics, Quality, Stability, etc.

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, CROs, 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…