Lead - Clinical Study Management

Reposted 2 Days Ago
Be an Early Applicant
2 Locations
In-Office or Remote
124K-185K Annually
Senior level
Healthtech • Biotech
The Role
Lead complex clinical studies from start to finish, ensuring compliance and oversight, while acting as a point of contact for stakeholders.
Summary Generated by Built In

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?

  • 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.

Stay connected by joining our Talent Community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.  

Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.

Explore our website and learn more about our mission, our team, and the opportunities we offer. 

 

Top Skills

GCP
Ich-Gcp
Iso 14155
Am I A Good Fit?
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The Company
Andover, MA
15,318 Employees

What We Do

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential.

From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place.

Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart.

Through a spirit of ownership and can-do attitude, we work together to win..

We’re a company of people who care about each other, about our customers and their patients, and about our communities.

Together, we fulfill our shared purpose of Life Unlimited.

Please note: not all products referred to may be approved for use or available in all markets.

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