Lead, Study Site Management (Monitoring)

Smith+Nephew•Minneapolis, MN

1d•Remote

About The Position

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.

Requirements

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
Ability to travel up to 25 percent

Nice To Haves

ACRP or SoCRA certification preferred
Experience with risk based monitoring, Veeva Vault, Medidata, and Microsoft 365

Responsibilities

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