Global Clinical Trial Lead

Key responsibilities:

• Leads and facilitates cross-functional interfaces and interactions within the Clinical Trial Team and external partners (i.e., CRO and other vendors)
• Provides direct input to protocol development and other essential trial-level documents to ensure efficient and effective delivery of trial objectives and in accordance with the relevant Standard Operating Procedures
• Develops, executes, and maintains operational Risk Management Plan highlighting potential risks and actions
• Creates and drives trial level milestones and timelines. Oversees trial level performance against the agreed plans (including global recruitment and projection plan), milestones and key performance indicators
• Ensures all trial-related documents and systems (e.g., clinical database, IRT etc.) required for Ethics/Regulatory submissions and trial initiation are developed by the Clinical Trial Team and CRO/vendors within the specified timelines
• Ensures selection of clinical trial sites which meet protocol requirements, and all essential documents are in place for approval of site initiation and release of Investigational Medicinal Products to the sites
• Ensures CRO/vendors contracted at trial level are performing to contractual obligations and timelines/budget and that oversight is documented and any issues are escalated appropriately
• Responsible for trial budget, reforecasting after initial budget estimate and for management through the trial lifecycle and provide budget process report including any financial risks and mitigation plans
• Ensures clinical trial is inspection-ready at all time and Trial Master File (TMF) completion including TMF plan is in place and ongoing QC activities are performed to always ensure TMP completeness

Your profile

• Bachelor’s Degree/Master’s Degree in Science or Healthcare
• 5-8 years of relevant clinical experience in pharmaceutical industry including 2-3 years of project management experience
• Excellent knowledge of Good Clinical Practice, regulatory process, and clinical development process
• Experience with health authority inspections (FDA/EMA) and audits preferred
• Strong critical thinking and problem-solving skills
• Strong team leadership and project management skills with ability to collaborate across function in a matrix environment
• Excellent communication, interpersonal and conflict management skills with ability in establishing and maintaining effective working relationships with internal and external team members and stakeholders
• Ability to work under pressure and managing competing priorities
• Demonstrated ability to effectively forecast and manage trial budget
• Fluent in English (French and another European language are an asset)