
Associate Director, Study Start-up
Posted 4 days ago

Posted 4 days ago
This is a fully remote position, open to applicants in United States.
• Lead and coordinate top-tier study start-up planning and execution for a global portfolio.
• Supervise and guide a team of Study Start-up Managers.
• Guarantee high-quality and compliant study start-up delivery across various programs and therapeutic areas.
• Oversee comprehensive study start-up planning and execution from a global to local level.
• Achieve milestones punctually, within budget, and in accordance with ICH-GCP and regulatory standards.
• Provide oversight at the portfolio level regarding study start-up performance, resource allocation, and delivery metrics.
• Identify risks and propose solution-oriented recommendations.
• Enhance team capabilities through coaching, mentoring, performance management, and exemplifying best practices.
• Collaborate with functional and hub leaders to improve study start-up capabilities, operational readiness, and methods of working.
• Own and integrate study start-up business processes.
• Facilitate training, knowledge sharing, and ongoing improvements.
• Promote a collaborative and highly engaging work culture.
• Contribute to the advancement of the Study Start-up Hub model and innovative working methods.
• Expertise in pharmaceutical and clinical trial processes and operations.
• Proven experience in leading and managing global teams.
• Background in project management.
• Doctorate degree with 3 years of clinical execution experience OR Master’s degree with 7 years of clinical execution experience OR Bachelor’s degree with 9 years of clinical execution experience OR Associate’s degree with 12 years of clinical execution experience OR high school diploma/GED with 14 years of clinical execution experience.
• At least 3 years of experience in direct people management and/or leadership roles overseeing teams, projects, programs, or resource allocation.
• Managerial experience may coincide with the required technical experience.
• 7 years of professional experience in the life sciences sector, especially in clinical trials, including 5 years in biopharmaceutical clinical research at a biotech or pharmaceutical organization (preferred).
• Experience in managing multiple teams or direct reports across various clinical functions (preferred).
• Previous experience with Veeva is not required.
• Comprehensive employee benefits package.
• Retirement and Savings Plan with generous contributions from the company.
• Group medical, dental, and vision insurance coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Bi-annual company-wide shutdowns.
• Flexible work models, including remote work options where feasible.
• Opportunities for career development.
• Support for work/life balance.
Mercy Health
Mercy Health
Bon Secours
Bon Secours
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