Syneos Health - Germany

Clinical Trial Supplies Mgr

Location
Based, US Home
Salary
Competitive
Posted
28 Apr 2021
Closes
28 May 2021
Ref
21005020
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Clinical Trial Supplies Manager

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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
Project Leadership and Delivery:
• 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 deliver ables 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 opportunitiesWhat 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
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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.