Manages full GCS oversight for high complex global clinical trials
Ensures project/study activities are in compliance with company and client requirements
Mentors, trains and provides on-going support to junior team members
May act as main contact and escalation point for assigned clients
Provides consultation services to clients and may develop and update client-specific manuals
Builds and maintains client relationship
Develops client specific governance and/or standards for each assigned client
Meets with internal teams to coordinate efforts, provide recommendations and risks, and update project reports/spreadsheets
Integrates all GCS activities to support project strategy and compliance with GxP requirements
Participates in ongoing training on new regulations
Participates in aspects of the bidding process including providing insight, strategy development, proposal development and parameters for business deliverables
Represents the department internally and externally at meetings, strategic projects, new business/business development strategy calls, bid reviews, bid defence meetings and initiatives as per the business requirements
Participates in or leads process improvement initiatives
Actively supports the roll-out of new processes within the department
Maintains and uses existing tools while continuously looking for improvement opportunities
Consults the client on the best strategy for management of the clinical trial
Builds strong internal and external network
Requirements
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)
Excellent English and communication skills both written and verbal
Exceptional interpersonal, planning, negotiation, influencing, organizational, problem solving, sense of urgency, critical thinking and decision-making skills
Demonstrated leadership and team building skills
Strong working knowledge of Microsoft Office suite
Comprehensive understanding of Global Clinical Supplies (GCS) concepts and application to clinical trials including a strong understanding of logistics and material management processes
Experience in Cell and Gene experience is an advantage