Job Description
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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
- Bachelorโs 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
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