Note: The job is a remote job and is open to candidates in USA. Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. The Clinical Supply Chain Manager will provide customer-focused leadership of operational and financial aspects of clinical trial supplies management, ensuring compliance and managing deliverables throughout the project life cycle.
Responsibilities
- Manages clinical trial supplies for assigned studies and ensures compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), relevant standard operating procedures (SOPs), and regulatory requirements
- Accountable for the operational delivery and financial performance of services assigned to the Clinical Supplies team
- Liaise with the Supply Chain Logistics Coordinator for IoR/EoR services as required
- Leads the identification of and contracting with approved Clinical Trial Supplies related vendors, as necessary
- Provides vendor management, inclusive of ensuring key Clinical Trial Supplies deliverables are met and financial parameters of contracts are upheld
- Defines supplies requirements in collaboration with client packaging and distribution vendors and the Project Lead (PL)
- Provides oversight for the creation, implementation and maintenance of drug and supply distribution plans
- Accountable for maintenance of project information on a variety of databases and systems
- Oversees the inventory, supply, and re-supply plans for subject kits and/or study medication required for the duration of a study and provides relevant reports for customers and management
- Provides oversight for development and implementation of project plans in accordance with Controlled Documents and ensures proper archival of records in Trial Master Files to ensure inspection readiness
- Develops contingency planning and risk mitigation strategies to ensure successful provision of all required clinical trial supplies
- Participates in bid defense meetings to demonstrate overall capabilities of the Clinical Trial Supplies Management team and specific strategies for management of clinical trial supplies logistics for new business opportunities
- Develops strong relationships with current and potential customers to ensure satisfaction and identify new business opportunities
Skills
- Bachelor's Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent
- Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company in project management or clinical trial supplies management
- Strong knowledge of Good Clinical Practice, ICH guidelines, Good Manufacturing Practices and other applicable regulatory requirements
- Strong organizational skills
- Strong ability to manage time and work independently
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
- Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
- High level of competency in English language
- Proficiency with MS Office Applications
- Ability to travel as necessary (up to 25%)
Benefits
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself.
Company Overview
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