[Hiring] Senior Manager, Study Start Up @Parexel

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Senior Manager, Study Start-up partners closely with the Clinical Operations study team leading global study start-up and site activation activities in Phase I-III and real-world evidence clinical trials. • Partner closely with CRO teams, internal study stakeholders, KOLs, external vendors, and site networks. • Drive top quality, best in class delivery, acceleration and optimization of study start-up, site activation and enrollment milestones. • Provide direct oversight, direction, and support beginning with early study planning, country and site selection, data-driven scenario planning, and enrollment forecasting. • Oversee and ensure the delivery of global (end-to-end) study startup activities at program/study level. • Create project plans for efficient implementation and oversight of appropriate processes, tools, and technologies. • Lead successful study and site activation oversight by removing complexity, conducting proactive risk mitigation, and removing obstacles for sites. • Excel in project management, organizational, and communication skills to share best practices with study teams, CROs, and internal stakeholders. Qualifications • Bachelor’s Degree in Science or related discipline required. • Significant (8+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies. • Considerable (5+ years) managing operational aspects of clinical studies. • Significant experience in leading global study start-up and site activation activities is required. • Must have experience working with external CROs and cross functional teams. • Broad-based experience in clinical development including clinical trial conduct, Study Start-up and feasibility, country and site selection and patient retention and recruitment. • Knowledge of GCP and a good understanding of the processes associated with clinical operations, study management and monitoring, and local regulatory requirements. Requirements • Responsible for driving global study start-up and site activation activities, milestone oversight, and CRO delivery. • Develop and deliver the global study startup plan by partnering with the CRO Study Startup team. • Lead development of procedures to enhance internal start-up capabilities and drive efficiencies. • Guide study teams through conduct and delivery of key startup activities within timelines. • Oversee the analysis of clinical trial data and its application to conduct accurate study startup forecasts. • Collaborate with internal Feasibility experts to drive rapid, accurate, and data-driven study startup forecasts. • Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Study Startup Services. • Participate in early, global, strategic study planning to ensure corporate goals and timelines are accurate and achievable. • Partner with CRO to ensure efficient start-up processes and reporting. • Work directly with internal study team members and CRO counterparts to progress site activations efficiently. • Track and report relevant KPIs and metrics including local country and site level cycle times. • Oversee consistent application of appropriate study start-up standards and processes. • Build and maintain study start-up, country and site activation best practices. • Support the recruitment and performance of junior staff; provide guidance for effective prioritization and problem-solving. Company Description Apply tot his job Apply To this Job