Lead - Clinical Study Management

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?
• 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

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.    
• Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement  
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day  
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program 
• Flexibility: Hybrid Work Model (For most professional roles)  
• Training: Hands-On, Team-Customized, Mentorship  
• Extra Perks: Discounts on fitness clubs, travel and more!  

The anticipated base compensation range for this position is $123,500-$184,775 USD annually or $123,500-$185,250 CAD. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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