Supports Study Start-up Manager in the development of country/cluster/hub study execution plans and timeline commitments
Participates in the recruitment sub-team and supports the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
Proactively identifies risk and opportunities for the assigned studies within the country/cluster/hub and develops respective mitigation plans
Drives the conduct of the study, (tracks status, maintains relevant reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
Oversees local study team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and relevant regulations
Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
Maintains oversight of country/cluster/hub level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
Qualifications
A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
Minimum 5 years’ experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
Capable of leading in a matrix environment, without direct reports and working cross-border managing study in various countries
Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
