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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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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