Smith+Nephew · 1 day ago
Lead - Clinical Study Management
United States
Full-time
Remote
Mid, Senior Level
$124K/yr - $185K/yr
3+ years expSmith+Nephew is a company that designs and manufactures technology aimed at enhancing quality of life. They are seeking a Lead – Clinical Study Management to oversee complex clinical studies, ensuring compliance and collaboration among teams throughout the study lifecycle.
Medical Device
Responsibilities
Lead and oversee all activities for large, complex Smith+Nephew-sponsored clinical studies from start-up through close-out
Act as the primary point of contact for internal and external stakeholders, ensuring strong collaboration across cross-functional teams
Develop and maintain essential study documents including protocols, monitoring plans, and consents
Manage vendor qualifications and maintain oversight throughout the study lifecycle
Support site identification and engagement, including investigator meetings and study communications
Ensure compliance with ICH-GCP, ISO 14155, and regional regulatory requirements
Monitor study quality through training, compliance reviews, and corrective actions
Oversee study budgets, timelines, and data integrity using established systems and processes
Qualification
Required
Bachelor's degree or higher in a scientific, clinical, or related field
GCP certification and in-depth knowledge of regulatory requirements
Extensive experience in clinical study management: BS + 6 years, MS + 3 years, or PhD + 1 year
Strong leadership, project management, and decision-making skills with the ability to handle complex projects independently
Excellent communication and relationship-building skills in English
Benefits
401k Matching Program
401k Plus Program
Discounted Stock Purchase Plan
Tuition Reimbursement
Flexible Personal/Vacation Time Off
Paid Holidays
Flex Holidays
Paid Community Service Day
Medical
Dental
Vision
Health Savings Account (Employer Contribution of $500+ annually)
Employee Assistance Program
Parental Leave
Fertility and Adoption Assistance Program
Hybrid Work Model (For most professional roles)
Hands-On, Team-Customized, Mentorship
Discounts on fitness clubs, travel and more!
Company
Smith+Nephew
Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Katerina Dodbiba
SVP, CFO Orthopaedics, Sports Medicine & ENT
Pierre Palassian
SVP, CFO Global Operations, Quality and Regulatory Affairs
Recent News
2025-10-06
2025-10-03
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