Global Clinical Lead - Sponsor Dedicated

The Global Clinical Lead/Study Lead - Country Operations - (SLCO) serves as the primary contact for the Country Operations Management (COM) team on a global study level, collaborating closely with the Clinical Project Lead (CPL) and other functional stakeholders. This role acts as the global representative for COM, facilitating communication between in-country teams and the global study team.

Key Responsibilities
• Collaborate with global and country teams to define the appropriate country footprint for the study and consolidate information to support internal governance approvals.
• Lead Key External Expert (KEE) outreach activities in partnership with Alexion Global Feasibility & Site Intelligence (GFSI) to evaluate study design suitability and identify opportunities for protocol improvement.
• Coordinate detailed site feasibility assessments with GFSI and work with country teams to finalize the proposed breakdown of countries, sites, and patients for endorsement by the Global Program Team (GPT).
• Oversee site start-up (SSU) activities performed by country teams and/or CRO partners.
• Contribute to the development and execution of patient recruitment, retention, and engagement strategies, including insights from patient activities.
• Maintain oversight of study deliverables and site monitoring throughout the trial lifecycle, ensuring inspection readiness at all times.
• Address risks or issues related to site management and monitoring in collaboration with global and country-level stakeholders.

Qualifications, Expertise and Skillset
• 5+ years of clinical research experience in Biopharma or CRO
• Experience of managing multiple studies including extensive experience in the management and oversight of CROs
• Experience of ultra-rare disease clinical research is beneficial
• Demonstrated project leadership skills
• Extensive clinical trial experience across a range of complex disease areas
• Demonstrated capability of effective monitoring oversight
• Ability to operate effectively in a highly matrixed team environment
• Ability to work autonomously and within a team structure and able to demonstrate initiative
• Solid knowledge of clinical development processes with strong emphasis on monitoring
• Track record of establishing effective relationships with investigator sites
• Ability to lead, troubleshoot and influence for quality and delivery
• A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
• Demonstrates flexibility in schedule and ability to travel as required internationally and domestically

This role is not eligible for UK visa sponsorship

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