Clinical Trial Supplies Manager ** EMEA based **Clinical Trial Supplies ManagerSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.WORK HERE MATTERS EVERYWHEREJob ResponsibilitiesManages logistics of clinical trial supplies for assigned studies as an independent Clinical Trial Supplies Manager (CTSM); ensures compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), relevant standard operating procedures (SOPs), and regulatory requirements.Ensure operational delivery and financial performance of services assigned to the CTSM team.Identifies clinical trial supply vendors; manages contracting of preferred vendors, as required.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 PL.Works with the PL to obtain parameters and inputs to implement and maintain drug and supply distribution plans.Directs activities of assigned Clinical Trial Supplies Associates (CTSAs); ensures proper resource levels to deliver work.Reporting And CommunicationAccountable 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.Develops and implements project plans in accordance with Controlled Documents and ensures proper archival of records in Trial Master Files to ensure inspection readiness.May prepare, coordinate, and present project material at internal and external meetings (e.g., internal team training meetings, Investigator meetings).Develops contingency planning and risk mitigation strategies to ensure successful provision of all required clinical trial supplies.Business DevelopmentMay participate in bid defence meetings for new business opportunities to articulate capabilities of the CTSM team and proposed strategies for management of clinical trial supplies logistics.Develops strong relationships with current and potential customers to ensure satisfaction and identify new business opportunities.QualificationsBachelor'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%).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 is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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