Description
Syneos Health is seeking a Clinical Supply Chain Manager to lead the operational and financial aspects of clinical trial supplies management during the complete project life cycle. The successful candidate will provide customer-focused leadership, liaising with customers, vendors, and investigative sites to manage Clinical Trial Supplies deliverables.
Core Responsibilities
- Manage clinical trial supplies for assigned studies and ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), relevant standard operating procedures (SOPs), and regulatory requirements
- Be 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
- Lead the identification of and contracting with approved Clinical Trial Supplies related vendors, as necessary
- Provide vendor management, inclusive of ensuring key Clinical Trial Supplies deliverables are met and financial parameters of contracts are upheld
- Define supplies requirements in collaboration with client packaging and distribution vendors and the Project Lead (PL)
- Provide oversight for the creation, implementation, and maintenance of drug and supply distribution plans
- Be accountable for maintenance of project information on a variety of databases and systems
- Oversee the inventory, supply, and re-supply plans for subject kits and/or study medication required for the duration of a study and provide relevant reports for customers and management
- Provide oversight for development and implementation of project plans in accordance with Controlled Documents and ensure proper archival of records in Trial Master Files to ensure inspection readiness
- Develop contingency planning and risk mitigation strategies to ensure successful provision of all required clinical trial supplies
- Participate 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
- Develop strong relationships with current and potential customers to ensure satisfaction and identify new business opportunities
Qualifications
- Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing, or a related field
- 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 Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.