Lead - Clinical Study Management

Smith+Nephew•Minneapolis, MN

8d•Remote

About The Position

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Join us as a Lead – Clinical Study Management and play a pivotal role in shaping the future of clinical research. This is your opportunity to lead complex, global studies that make a real difference to patients’ lives—all while working remotely from anywhere in the US or Canada. What will you be doing? 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 What will you need to be successful?

Requirements

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

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