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Role Description
In this role, you will lead the planning, execution, and delivery of complex clinical trials, potentially spanning multiple studies. You will provide strategic and operational oversight to ensure trials are completed on time, within budget, and in compliance with regulatory and quality standards. Acting as the primary cross-functional study lead, you will coordinate teams, vendors, and investigators while driving consistent progress toward key milestones. This role offers the opportunity to influence study design, optimize operational efficiency, and enhance patient and site engagement. Success requires strong leadership, attention to detail, and the ability to manage competing priorities in a fast-paced clinical research environment. You will contribute directly to advancing innovative therapies, ensuring high-quality data and impactful outcomes.
• Develop and execute study operational plans, driving trial execution strategies and vendor governance to meet study milestones.
• Oversee the creation, review, and maintenance of study documents including protocols, ICFs, CRFs, CSRs, and training manuals.
• Ensure compliance with GCP, ICH E6 (R3), SOPs, and regulatory requirements through monitoring, quality control, and risk management.
• Manage clinical trial budgets, site agreements, accruals, and vendor invoices, maintaining accurate financial oversight.
• Build and maintain strong relationships with investigators, site staff, and cross-functional teams to support study conduct and data integrity.
• Provide oversight of CROs and vendors, including selection, onboarding, performance management, and issue resolution.
• Lead and mentor team members, ensuring resources are aligned, goals are clear, and performance meets trial milestones.
Qualifications
• Bachelor’s degree in a scientific or medical field (or equivalent experience). Advanced degrees preferred.
• 10–12 years of clinical operations experience in the biopharma industry.
• Proven track record leading cross-functional teams to deliver clinical trials from start-up to close-out, including financial management, data review, and reporting.
• Strong expertise in vendor management, eTMF, SOP development, CAPA management, and quality assurance.
• In-depth knowledge of clinical trial design, protocol development, GCP, ICH E6 (R3), and GDPR; experience with rare or orphan diseases preferred.
• Exceptional leadership, organizational, and multitasking skills, with excellent written and oral communication.
• Experience with project management and collaboration tools (e.g., Smartsheet) is a plus.
• Willingness to travel periodically to fulfill role responsibilities.
Benefits
• Competitive salary range: $177,700—$220,000 USD (depending on experience and location).
• Annual performance bonus and company equity opportunities.
• Comprehensive health, dental, vision, and wellness benefits.
• Retirement savings plans with employer contributions.
• Flexible work environment with remote options and support for professional growth.
• Paid time off, holidays, and additional leave benefits to support work-life balance.
• Opportunities for training, mentoring, and career development in a global clinical research environment.
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