[Hiring] Senior Manager, Study Start Up @Parexel

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