Define, develop and deliver the global start up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions and others as required
Take full responsibility for small to medium size studies located in a single country or region
Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan
Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
Co-ordinate and oversee progress of study specific or country specific tasks that need to be completed for site activations
Expertly integrate the requirements of a protocol amendment(s) to deliver site activations to plan
Act as a key point of escalations for site activation related issues raised by country level start up roles
Continually assess current and future workload to proactively anticipate, problem solve

Extensive global start up clinical trial/study management experience
Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
Extensive knowledge of clinical trial methodology
Demonstrated start up experience
Demonstrated project management experience
Country or Regional start up exposure/experience in the countries under responsibility across at least two major therapeutic areas
Technical expertise in use of software (off the shelf and custom) for the management of clinical studies with prowess in using reporting systems (dashboards and associated basic data analysis) to comprehend and communicate status
Ability to use basic generative artificial intelligence techniques in daily work
Fluency in English is required
A scientific or technical degree is preferred
Must have a BS/BA – 5 years relevant experience
MS/PhD – 3 years relevant experience

Study Start Up Project Manager – FSP

Key skills