This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Site Manager based in the United States.
This remote role offers the opportunity to support the advancement of innovative clinical research by overseeing site management activities and ensuring successful clinical trial execution. The Clinical Site Manager will serve as a subject matter expert, guiding monitoring strategies, regulatory compliance, and operational excellence across complex studies.
Accountabilities
The Clinical Site Manager will provide strategic oversight of clinical site management activities, ensuring studies are conducted efficiently, compliantly, and according to regulatory and quality standards.
- Serve as a subject matter expert for monitoring and site management activities across assigned clinical studies.
- Review study-level trends, escalations, and action items to improve site management efficiency and support successful trial execution.
- Evaluate monitoring visit reports to ensure compliance with study plans, procedures, and applicable requirements.
- Partner with project stakeholders to coordinate meetings, resolve challenges, and ensure study deliverables remain on schedule.
- Provide strategic guidance for field monitoring activities, clinical data review, and documentation quality across complex clinical trials.
- Assess clinical trial documentation, reports, records, and data for consistency with protocols, case report forms, regulatory requirements, and study objectives.
- Support clinical trial safety oversight while ensuring adherence to Good Clinical Practices (GCP), protocols, and regulatory expectations.
- Develop and deliver training related to clinical trial processes, compliance requirements, device accountability, adverse event reporting, and study documentation.
- Resolve complex data, documentation, and regulatory issues escalated by clinical research team members.
- Mentor and develop Clinical Research Associates by providing guidance, coaching, and opportunities for skill development.
- Support site qualification, initiation, monitoring, and close-out visits, ensuring proper documentation and compliance throughout the study lifecycle.
- Assist with the creation of study tools, trackers, training materials, SOP improvements, and process optimization initiatives.
- Participate in clinical trial audits and support ongoing quality assurance activities.
Requirements
The ideal candidate is an experienced clinical research professional with strong site management expertise, regulatory knowledge, and the ability to lead complex clinical trial activities.
- Bachelor's degree or equivalent in a science-related field required; advanced degree preferred.
- At least 5 years of field monitoring experience in clinical research.
- 2–3 years of experience in a Lead CRA, clinical project management, or similar leadership role.
- Experience with electronic data capture systems and Clinical Trial Management Systems required; familiarity with Veeva Vault CTMS/eTMF and Medidata Rave EDC preferred.
- Prior experience supporting Class II or Class III medical device clinical trials preferred.
- Strong understanding of clinical research regulations, Good Clinical Practices (GCP), quality assurance processes, and compliance standards.
- Experience managing clinical documentation, informed consent review, regulatory submissions, and trial-related processes.
- Excellent written and verbal communication skills, including stakeholder management and negotiation abilities.
- Strong problem-solving, analytical thinking, organizational, and project management skills.
- Proficiency with Microsoft Office Suite, including Word, Excel, and Adobe tools.
- Clinical research certification such as ACRP or SoCRA certification preferred.
- Ability to travel up to 50% throughout the United States as required.
Benefits
- Competitive annual compensation ranging from $109,000 to $174,800, based on experience and qualifications.
- Fully remote work opportunity within the United States.
- Eligibility for annual performance-based bonus opportunities.
- Comprehensive benefits package including medical, dental, vision, life insurance, disability coverage, and legal insurance.
- Retirement savings opportunities, including 401(k) and pension plan participation where applicable.
- Long-term incentive program eligibility.
- Generous paid time off, including vacation, sick leave, holidays, and personal/family time benefits.
- Opportunity to contribute to innovative healthcare solutions and impactful clinical research programs.
- Professional growth opportunities within a global healthcare and technology environment.
How Jobgether Works
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps are managed by their internal team.
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