About Us
Role Summary
The Head of Global Site Management leads all site-facing clinical trial activities across the global development portfolio. This operational leadership role is responsible for Site Management & Monitoring and Clinical Trial Optimization & Strategic Partnership functions. This role provides strategic leadership for site start-up, site management, and monitoring to drive predictable execution, accelerate timelines, improve enrollment performance, ensure high-quality data, and establish strategic site partnerships.
As a member of the Clinical Operations senior leadership team, this role is also responsible for supporting strategic initiatives across the development organization.
Key Responsibilities
- Build & lead global site management, monitoring, and study start-up activities across all clinical programs
- Develop and execute site strategies to optimize selection, activation, enrollment, and retention
- Establish consistent monitoring models, including risk-based monitoring approaches
- Build and maintain strategic relationships with investigative sites, site networks, and partners
- Partner closely with Clinical Operations, Clinical Development, Biometrics, and Development Services to ensure seamless, disciplined program and trial execution
- Identify and mitigate site-level operational and quality risks
- Establish scalable processes, metrics, and dashboards to track and improve site performance
- Establish operating model inclusive of vendor strategy, oversight, risk management, key performance metrics, and dashboards
- Provide expert insight into operational strategy plans (feasibility, monitoring strategies) and operating budgets
- Create and continuously improve standard operating procedures, work instructions, to ensure inspection readiness
- Participate in regulatory authority inspections, sponsor audits, and oversee site audits in partnership with Quality
- Ensure compliance with GCP, regulatory requirements, and internal standards
- Ability to assess and transform capabilities through AI and Automation solutions or strategies
- Up to 20-30% domestic and international travel, as required.
Qualifications
- Bachelor's degree in life sciences or related field
- 12+ years of experience in site management or clinical operations leadership
Or advanced degree (PhD, MBA, Masters) and 10+ yrs of experience
- Deep expertise in global study start-up and enrollment optimization
- Strong people leadership and stakeholder management skills
Top Skills
What We Do
Kardigan is a patient-driven heart health company that is modernizing cardiovascular drug development to deliver medicines that move patients beyond symptom management to functional cures. By matching critical disease drivers with treatment responders identified in clinical trials, Kardigan is developing a portfolio of medicines that modify the underlying cardiovascular disease pathophysiology to get patients closer to the cures they deserve. For more information about Kardigan, please visit kardigan.bio. If you are interested in joining our passionate and driven team with deep cardiovascular, biotechnology and operational expertise, please visit kardigan.bio or the careers tab of this page.
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