Lead, Study Site Management (Monitoring)

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

As a Lead Study Site Management professional, you will play a critical role in shaping the quality and consistency of clinical monitoring across our global clinical research portfolio. This is an opportunity to step into a highly visible leadership role where your expertise will influence patient safety, data integrity, and the successful delivery of innovative medical device studies. Working remotely within the USA, you will collaborate with cross functional partners and guide monitoring teams to deliver excellence at scale.

What will you be doing?

• Providing leadership and operational oversight for Clinical Research Associates supporting global medical device clinical studies

• Leading CRA onboarding, training, coaching, mentoring, and performance management using defined quality and compliance metrics

• Acting as the primary escalation point for monitoring issues and driving timely resolution

• Reviewing monitoring visit reports to ensure quality, completeness, and timeliness

• Partnering closely with study teams and cross functional stakeholders to ensure efficient study execution

• Ensuring compliance with Smith+Nephew SOPs, ICH GCP, FDA regulations, and ISO 14155 standards

• Conducting co monitoring and assessment visits for high risk or non compliant sites as required

• Providing clear communication and reporting to senior leadership on monitoring performance, trends, risks, and mitigation strategies

• Identifying and implementing continuous improvement initiatives and best practices in clinical monitoring

What will you need to be successful?

• Bachelor's degree or higher in Life Sciences or a related field

• Minimum of 7 years of clinical research experience including site monitoring

• At least 2 years of experience in a Lead or Senior CRA role

• Strong working knowledge of ICH GCP, FDA regulations, medical device standards, and ISO 14155

• Proven experience overseeing global or remote monitoring teams, including FSP or contingent CRA models

• GCP certification required; ACRP or SoCRA certification preferred

• Experience with risk based monitoring, Veeva Vault, Medidata, and Microsoft 365

• Ability to travel up to 25 percent

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 and Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account with employer contribution, 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!

We anticipate the application window for this opening to close on 05.22.2026.

The anticipated base compensation range for this position is $125,000 - $188,000 USD annually .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.

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