Leads the coordination of import and export activities for commercial products, ancillary supplies, investigational products and biological samples for highly complex global clinical trials, ensuring that activities are in full compliance with company and client requirements and applicable local regulations. Mentoring/guiding more junior team members. Provides consultation services to the clients
- Develops and executes an import/export plan for each assigned project and provides consultation on international requirements and customs.
- Meets with and directs internal teams to coordinate efforts, provide recommendations and alerts, and update project reports/ spreadsheets.
- Ensures fluent communication and interaction between internal departments in order to avoid obstacles during the import/export process and ensure compliance with all applicable regulations.
- Integrates all import and export activities into the clinical supply chain to support project logistic strategy and compliance with internal policies.
- Leads ongoing training on new regulations concerning both import/exports and GMP activities.
- Leads process improvement initiatives.
- Participates in the bidding and/or bid defense opportunities regarding the addition of import/export services.
- Represents the department to clients on complex study design matters, directly contributing to complex study proposals and bids. Consults with the client/vendor on the best import export estrategy for the clinical trial.
- Participates in process improvement initiatives continously looking for improvement opportunities to existing tools.
- Provides coaching, mentorship and guidance to more junior team members.
Education and Experience:
- Bachelor’s degree or equivalent and relevant formal academic/vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years).
- Prior experience in the clinical research industry, specifically in the area of clinical supplies, import/export, or QA/Regulatory Affairs is preferred.
Knowledge, Skills and Abilities:
- Familiar with clinical supply terminology, practices and principles.
- Sound understanding of global clinical supply customs and trade regulations, to include understanding of protocol interpretation and import/export logistics.
- Sound understanding of CGMP, GCP and ICH.
- Excellent communication skills both written and verbal, including a high level of English
- Exceptional interpersonal, planning, organizational, problem solving, sense of urgency and decision making skills.
- Effective ability to lead, motivate teams and teach/mentor team members
- Strong working knowledge of Microsoft Office suite
- Sharp focus on customers and attention to detail
- Ability to work in team environment, as well as work completely independent
- Exceptional in client and 3rd party relationship management
- Excellent ability to provide customer service with the highest standards of quality and excellence
- Skilled in bid preparation and bid defense