Start Up Project Manager II

Role Overview

• The Start Up Project Manager is responsible for defining, developing and delivering the global start up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions and others as required.
• The SUPM will be assigned to one or more interventional studies in one or more therapy areas such as oncology, vaccines, internal medicine, rare disease or inflammation and immunology.
• The SUPM will have a comprehensive knowledge of managing and coordinating study start up activities globally.
• The SUPM will typically take full responsibility for medium to large size studies across all regions and countries, or for selected countries or region(s) of a global study where another SUPM is responsible for the site activations of the entire study.
• The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their 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).
• Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system.
• Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system which build the overall targets for site activation over time in alignment with the priority of the study in the overall portfolio and overall expectation to deliver to plan with a high degree of probability.
• Expertly integrate the requirements of a protocol amendment(s) to deliver site activations to plan prioritizing optimizing participant recruitment.
• 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.

Requirements

• Demonstrated clinical research experience
• Demonstrated start up experience
• Demonstrated project management experience
• Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
• Concurrent management of complex processes within and across countries in multiple regions of the world
• Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
• Expert ability to comprehend status and adapt communications across a diverse audience
• Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
• Will use generative artificial intelligence techniques in daily work
• Uses risk management techniques as standard to identify and mitigate key project delivery risks
• Critical thinker with strategic planning, analytical and problem-solving skills that responds positively to rapid change
• 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
• Fluency in English is required.

Benefits

• Health insurance
• Professional development opportunities