Clinical Trial Supplies Manager

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

Leadership and Delivery

• 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

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
• 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

Business Development

• 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

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.

Summary

The position provides customer-focused leadership of operational and financial aspects of clinical trial supplies management during the complete project life cycle. Duties include liaising with customers, vendors, and/or investigative sites to manage Clinical Trial Supplies deliverables. Assignments may range in size and complexity from single service studies to full scope, multiple protocol projects and/or global projects across various phases and functional areas.