Senior Manager, Study Start-up

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for overseeing global study start-up and site activation initiatives, including milestone management and CRO performance delivery.

• Create and implement the global study startup strategy in collaboration with the CRO Study Startup team.

• Lead the formulation of procedures aimed at enhancing internal start-up capabilities and driving efficiencies in line with Trial Delivery Optimization objectives.

• Direct study teams in the execution and delivery of essential startup activities within established timelines, contributing to operational planning and decisions for predictable achievement of R&D objectives.

• Supervise the examination of clinical trial data and its utilization for precise study startup forecasting.

• Work alongside internal Feasibility professionals to promote swift, precise, and data-informed study startup forecasts, while benchmarking assumptions and scenarios for accurate planning.

• Innovate processes, methodologies, data, and technologies to guarantee the continuous delivery of valuable Study Startup Services.

• Engage in early, global, strategic study planning to ensure that corporate goals and timelines for study start-up and site activation are realistic and attainable; ensure CRO accountability for all study deliverables and timelines.

• Collaborate with CROs to ensure streamlined start-up processes and reporting, facilitating optimal country and site activations.

• Coordinate with internal study team members and CRO counterparts to advance site activations effectively and in accordance with targeted milestones; ensure prompt resolution of site-level challenges by leveraging in-country insights and expertise to eliminate or avert obstacles.

• Monitor and report on key performance indicators (KPIs) and metrics, including local country and site-level cycle times, to support process enhancements and overall operational/business reporting aimed at expediting site activation.

• Ensure the consistent application of appropriate study start-up standards and procedures to deliver high-quality, cost-effective clinical studies in compliance with local operational, legal, and regulatory requirements.

• Establish and uphold best practices for study start-up, country, and site activation.

• Assist in the recruitment and performance management of junior staff; offer guidance for effective prioritization, problem identification, and resolution, leading to enhanced strategic drug development operational efficiency.

⛳️ Requirements

• A Bachelor’s Degree in Science or a related field is mandatory.

• Extensive experience (8+ years) acquired from a CRO or biopharmaceutical organization involved in multinational clinical studies.

• Significant (5+ years) experience in managing the operational facets of clinical studies.

• Proven experience in leading global study start-up and site activation activities is essential.

• Must have a background in collaborating with external CROs and cross-functional teams.

• Comprehensive experience in clinical development encompassing clinical trial execution, study start-up and feasibility, country and site selection, as well as patient retention and recruitment.

• Familiarity with GCP and a strong understanding of the processes related to clinical operations, study management, monitoring, and local regulatory requirements.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development