Support operational management of study activities, assist in study implementation, ensure compliance with protocols, and maintain effective relationships with community partners while engaging with families and children for recruitment and data...

• Manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes • Leads RBM strategy meetings and develops study-specific site monitoring plan, aligned with study risk assessment • Ensures monitoring strategies are configured in technology capabilities • Manages Site Monitoring assignments in client's systems • Provides Site Monitoring training and supports the creation and delivery of site monitoring materials • Serves as primary reviewer of site monitoring visit reports • Reviews systems and dashboards to assess site monitoring compliance • Supports site monitoring needs during study conduct • Provides site management back-up as needed while Site Monitors are conducting site monitoring visits • Triggers and manages or conducts Monitoring Oversight Visits • Partners with RBQM Operations team to address unresolving centralized monitoring findings with sites • Performs periodic assessment of site monitoring / RBM compliance KPIs and KQIs

• Design and conduct clinical studies that evaluate the safety and efficacy of innovative treatments. • Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations. • Contribute to the identification, formulation and implementation of amendments to the clinical protocol, in close collaboration with clinical lead. • Contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. • Contribute to the review and writing of clinical trial documents for CTR activities, and publications (as applicable) • Support pharmacovigilance activities (e.g. contributing to creation and review of aggregate reports, patient narratives and attendance of pharmacovigilance monitoring meetings) • Support regulatory activities (preparation of meetings with regulatory agencies). • Produce training materials, share best practices and provide training to the broader clinical trial teams. • Support preparation and (if applicable) participate in study level meetings (i.e. - Investigator Meetings, Data Monitoring meetings, and others). • Support and guide the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites). • Include support for Case Report Form (CRF) development, and implementation of data capture tools. • Deep expertise to perform in depth and high-quality clinical data review, to identify clinical data insights through ongoing patient level review and trends analysis to support Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle. • Work to improve the quality of reviews and insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review. • Provide insights to and facilitate data review process improvements by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement.

Develop and execute clinical strategies for oncology diagnostic products, manage clinical validation studies, and collaborate cross-functionally to support regulatory submissions and product development, ensuring scientific rigor and alignment with...