Senior Manager, Study Start Up - FSP

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. This team member will also partner closely with CRO teams, internal study stakeholders, KOLs, external vendors, 
and site networks to drive top quality, best in class delivery, acceleration and optimization of study start-up, site activation and enrollment milestones. The Senior Manager, Study Start-up provides direct oversight, direction, and support beginning with early study planning, country and site selection, data-driven scenario planning, and enrollment forecasting to ensure predictable and consistent delivery. The Senior Manager, Study Start-up will oversee and ensure the delivery of global (end-to-end) study startup activities (strategy, plans, activities, timelines, and synthesis of study startup insights and presentation to study teams) at program/study level.

The Senior Manager, Study Start-up will serve as an expert across the study start-up, country, and site activation landscape. The Senior Manager, Study Start-up creates project plans for efficient implementation and oversight of appropriate processes, tools, and technologies to accelerate start-up activities. This candidate leads successful study and site activation oversight by removing complexity, conducting proactive risk mitigation, and removing obstacles for sites to successfully activate within study and corporate objectives. The Manager, Study Start-up excels in project management, organizational, and communication skills to clearly share best practices with study teams, CROs, and internal stakeholders across the Clinical Operations organization to deliver consistent application of these practices. 
 

Key Accountabilities:

• 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 to align with Trial Delivery Optimization goals.

• Guide study teams through conduct and delivery of key startup activities within timelines that contribute to operational planning/decisions resulting in predictable delivery for achieving R&D goals.

• 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, benchmarking assumptions, scenarios and accurate planning.

• 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 for study start-up and site activation are accurate and achievable; ensure CRO commitment to all study deliverables and timelines.

• Partner with CRO to ensure efficient start-up processes and reporting to deliver best in practice country and site activations.

• Work directly with internal study team members and CRO counterparts to progress site activations efficiently and as per targeted milestones; facilitates timely resolution of site-level issues by utilizing in-country intel and expertise to remove or prevent roadblocks

• Tracks and reports relevant KPIs and metrics including local country and site level cycle times to support process improvement and overall operational/business reporting to accelerate site activation

• Oversee consistent application of appropriate study start-up standards and processes to deliver high quality, cost effective clinical studies in line with local operational, legal and regulatory requirements

• 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, problem identification and solving resulting in improved strategic drug development operational efficiency

Skills & Requirements:

• 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.

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