Description Clinical Trial Supplies Manager (Remote Based)
Job ResponsibilitiesClinical Trial Supply Management- Lead end-to-end clinical trial supply planning and logistics for assigned studies.
- Develop and maintain supply forecasts, inventory plans, distribution strategies, and resupply plans.
- Ensure compliance with GMP, GCP, SOPs, and regulatory requirements.
- Monitor inventory levels, product expiry dates, and supply risks to ensure uninterrupted study execution.
- Oversee packaging, labeling, distribution activities, and Interactive Response Technology (IRT) supply strategies.
- Facilitate discussions and decisions on label and packaging design, as needed.
Project Leadership & Cross-Functional Collaboration- Represent Clinical Supply Chain on Clinical Study Teams.
- Partner closely with Clinical Operations, Project Management, Technical Operations, Procurement, and Supply Chain teams.
- Lead cross-functional supply meetings and drive timely decision-making.
- Align supply plans with study timelines, enrollment forecasts, and operational requirements.
Vendor & Budget Management- Identify, select, and manage clinical supply vendors and service providers.
- Oversee vendor performance, contract deliverables, and financial commitments.
- Manage co-medication sourcing and associated budgets and spending.
Risk Management & Reporting- Develop contingency plans and mitigation strategies to address supply risks.
- Track and report inventory, supply status, forecasts, and project metrics.
- Maintain study documentation and Trial Master Files to ensure inspection readiness.
Leadership & Process Improvement- Participate in SOP development and departmental process improvement initiatives.
- Support internal training and contribute to operational excellence projects.
Qualification- Bachelor's degree (or equivalent) in Life Sciences, Medicine, Pharmacy, Nursing, or a related field.
- Prior experience within a Contract Research Organization (CRO), pharmaceutical, or biotechnology company, with responsibilities in project management and/or clinical trial supplies management.
- Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, Good Manufacturing Practice (GMP), and applicable regulatory requirements.
- Knowledge of IRT system set-up, functionality, and proficiency with excel modeling - support IRT user acceptance testing, develops IRT supply strategy, and oversees ongoing supply activities in the system
- Excellent organizational and project management skills.
- Demonstrated ability to manage time effectively and work independently.
- Strong written and verbal communication, presentation, and interpersonal skills, with the ability to inform, influence, and persuade stakeholders.
- Proven ability to manage multiple priorities and meet deadlines while maintaining a high standard of quality in a fast-paced environment.
- High proficiency in the English language.
- Advanced proficiency with Microsoft Office applications.
- Willingness and ability to travel as required, up to 25%.
Experience Requirements- Five to seven (5-7) years of relevant clinical trial experience.
- Minimum of three (3) years of experience as a Clinical Trial Supplies Manager (CTSM) or in a comparable clinical supply chain leadership role.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$79,800.00 - $139,600.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Summary The position provides customer-focused leadership in managing operational and financial aspects of clinical trial supplies management during the complete project life cycle. Duties may include liaising with Customers, vendors and/or investigative sites to manage Clinical Trial Supplies deliverables. Assignments may range in size and scope from single service to full scope and may include multiple studies. Accountable for successful execution of all assigned services, where success includes on time, on budget, high-quality/compliant deliverables that lead to satisfied customers.
