Remote (Global) Employment

Smith+Nephew is hiring a Senior Manager – Study Site Management (US - Remote)

About the Role

Smith+Nephew is hiring a Senior Manager – Study Site Management (US - Remote) for its Global Clinical Research Operations (GCRO) organization. You will be an experienced intermediate-level manager responsible for leading the US Study Site Management team and managing the Global Monitoring Program. Your strategic work with leadership, cross-functional teams, study sites, and vendors will ensure clinical study success, alignment with business strategy, and compliance with regulatory and company requirements.

What You'll Do

  • Lead direct reports within the Study Site Management (SSM) team who coordinate site management and regional vendor activities.
  • Manage the Global Monitoring Program via vendor management and oversight of in-direct reports.
  • Review and assess monitoring needs ensuring adequate CRA resource and budget adherence.
  • Assign team responsibilities with clear goals and objectives, aligned to business strategy and priorities.
  • Oversee team performance and compliance via Key Performance Indicators.
  • Foster a culture of continuous learning, development, and process improvement.
  • Act as a subject matter expert and provide guidance to the team and others.
  • Ensure selection and oversight of well-qualified sites and vendors that enable efficient study execution and high-quality data.
  • Accountable for team’s successful execution of studies via strong cross-functional collaboration and effective utilization of study systems.
  • Oversee development of study documents such as global monitoring plans and regional site documents.
  • Proactively manage risk via identification, escalation, mitigation plans and resolution.
  • Continually monitor the health of assigned programs, sites and vendors.
  • Work closely with other functions including Clinical Study Management, Data Management, Medical Affairs, Legal, and Compliance.
  • Maintain effective communication channels with senior leadership and relevant stakeholders.
  • Develop and maintain strong working relationships with potential and existing vendors and site personnel.

What We're Looking For

  • Bachelor of Science or greater.
  • BS plus 7 or MS plus 5 years' experience in clinical research.
  • At least 3 years' direct people management experience in clinical research.

Nice to Have

  • Good Clinical Practice (GCP) knowledge.
  • Professional Society Training/Certification (e.g., ACRP, SoCRA).

Team & Environment

You will lead the US Study Site Management team within the Global Clinical Research Operations (GCRO) organization.

Benefits & Compensation

  • Compensation: $129,750.00 - $160,000.00 USD annually
  • 401k Matching Program
  • 401k Plus Program
  • Discounted Stock Options
  • Tuition Reimbursement
  • PTO
  • Paid Holidays
  • Flex Holidays
  • Paid Community Service Day
  • Medical, Dental, Vision
  • Health Savings Account (Employer Contribution of $500+ annually)
  • Employee Assistance Program
  • Parental Leave
  • Fertility and Adoption Assistance Program
  • Hands-On Training
  • Team-Customized Training
  • Mentorship
  • Discounts on fitness clubs, travel and more

Work Mode

This is a remote position located in the United States.

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.

Required Skills
Clinical ResearchStudy ManagementSite ManagementRegulatory ComplianceFDA RegulationsICH-GCPProject ManagementTeam LeadershipVendor ManagementBudget ManagementClinical OperationsCommunicationStakeholder ManagementProcess ImprovementCross-functional Collaboration
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About company
Smith+Nephew

Smith+Nephew designs and manufactures technology that takes the limits off living.

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Job Details
Category management
Posted 8 months ago