Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. The Science 37 Operating System (OS) enables universal access to patients and providers, leading to faster enrollment, greater retention and a more representative patient population. To help us achieve our goal, we are seeking a Director, Clinical Trial Supply Chain eager to make an impact within a mission-driven organization.
DUTIES AND RESPONSIBILITIES
Duties include but are not limited to:
- Project Leadership and Delivery
- Manages logistics of clinical trial supplies for assigned studies as Director, Clinical Trial Supplies Management (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.
- Works with the various internal and external trial leaders to obtain parameters and inputs to implement and maintain drug and supply distribution plans
- Directs activities of assigned other employees in the CTSM department; 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
QUALIFICATIONS & SKILLS
- 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
- Ability to travel as necessary
- Ability to communicate in English (both verbal and written)
Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
Submit your resume to apply!