Senior Clinical Trial Supplies Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead comprehensive clinical trial supply planning and logistics for designated studies

• Create and sustain supply forecasts, inventory strategies, distribution plans, and resupply schedules

• Ensure adherence to GMP, GCP, SOPs, and pertinent regulatory standards

• Monitor stock levels, product expiration dates, and potential supply risks

• Supervise packaging, labeling, distribution processes, and IRT supply strategies

• Represent the Clinical Supply Chain on Clinical Study Teams

• Collaborate with Clinical Operations, Project Management, Technical Operations, Procurement, and Supply Chain teams

• Conduct cross-functional supply meetings to facilitate timely decision-making

• Align supply plans with study schedules, enrollment projections, and operational needs

• Identify, select, and manage clinical supply vendors and service providers

• Oversee vendor performance, contractual obligations, and financial commitments

• Manage co-medication sourcing along with associated budgets and expenditures

• Develop contingency plans and risk mitigation strategies for supply issues

• Track and report on inventory, supply status, forecasts, and project metrics

• Maintain study documentation and Trial Master Files to ensure inspection readiness

• Provide guidance and oversight to Clinical Trial Supplies Associates

• Engage in SOP development and departmental process enhancement initiatives

• Support internal training and projects aimed at operational excellence

• Participate in bid defenses and client-facing presentations

• Cultivate customer relationships and assist in developing new business opportunities

⛳️ Requirements

• Bachelor’s degree (or equivalent) in Life Sciences, Medicine, Pharmacy, Nursing, or a related discipline

• Previous experience within a Contract Research Organization (CRO), pharmaceutical, or biotechnology firm, with responsibilities in project management and/or clinical trial supplies management

• Strong understanding of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, Good Manufacturing Practice (GMP), and relevant regulatory requirements

• Excellent organizational and project management capabilities

• Ability to effectively manage time and work independently

• Strong written and verbal communication, presentation, and interpersonal skills

• Capacity to inform, influence, and persuade stakeholders

• Ability to juggle multiple priorities and meet deadlines while delivering high-quality results in a fast-paced environment

• High proficiency in the English language

• Advanced skills in Microsoft Office applications

• Willingness and ability to travel as necessary, up to 25%

• Five to seven (5-7) years of relevant experience in clinical trials

• At least two (2) years of experience in a Clinical Trial Supplies Manager (CTSM) role or a similar clinical supply chain leadership position

🏝️ Benefits

• Career development and advancement opportunities

• Supportive and engaged management

• Technical and therapeutic training

• Peer recognition and total rewards program

• Company car or car allowance

• Medical, Dental, and Vision health benefits

• Company-matched 401k

• Eligibility to participate in Employee Stock Purchase Plan

• Opportunity to earn commissions/bonuses based on company and individual performance

• Flexible paid time off (PTO) and sick leave