Description
Clinical Trial Supplies Manager
Syneos 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.
Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE
Why Syneos Health
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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job responsibilities
Manages 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 Communication
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.
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 Development
May 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.
Qualifications
What we're looking for
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%).
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health
Additional Information:
Tasks, 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. 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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