Job Title

As a Study Start Up Project Manager you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing:The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study). Responsibility can be for all sites for an entire study or a portion of sites in specific countries in one or more regions.As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete.Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study.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 (by senior leadership). Start up meetings use the ongoing risk assessment of site activation delivery to form a focused agenda according to risk level, the overall goal is the delivery of major study milestones to plan (e.g. first subject first visit) as well as the overall delivery of major site activations to plan (25%, 50% and 90% of planned site activations)The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study, they will do so while considering the relative priority of their study compared to all concurrent studies in start up that country level start up roles are working on.Act as a key point of escalations for site activation related issues raised by country level start up roles, seeking to firstly resolve issues directly or triage appropriately to other SUPMs on the study or the study management team, will always follow through to resolution.Responsible for the completeness and quality of site activation timeline plans for every site from investigator initiation package sent for first site in study, to site activation complete for last site in study. Will work with and drive all timeline plan owners (e.g. country start up roles) to actively manage the site activation timeline plans for their assigned sites. The SUPM will have a detailed understanding of the timeline for every siteYou are:Extensive global start up clinical trial/study management experienceComprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operationsA scientific or technical degree is preferred along with extensive knowledge of clinical trial methodologyBS/BA 7 years relevant experienceMS/PhD 5 years relevant experienceFluency in English is requiredGlobal start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas