Clinical Site Manager
New
Based in the United StatesFull-TimeManager
Salary$109,000 to $174,800
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Job Details
- Experience
- At least 5 years of field monitoring experience in clinical research, plus 2–3 years of experience in a Lead CRA, clinical project management, or similar leadership role.
- Required Skills
- Project Management
Requirements
- 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.
- Strong understanding of clinical research regulations, Good Clinical Practices (GCP), and quality assurance processes.
- Experience managing clinical documentation, informed consent review, and regulatory submissions.
- Ability to travel up to 50% throughout the United States as required.
- Proficiency with Microsoft Office Suite (Word, Excel) and Adobe tools.
- Clinical research certification such as ACRP or SoCRA certification preferred.
- Prior experience supporting Class II or Class III medical device clinical trials preferred.
- Familiarity with Veeva Vault CTMS/eTMF and Medidata Rave EDC preferred.
Responsibilities
- 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.
- 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.
- Assess clinical trial documentation, reports, and data for consistency with protocols and regulatory requirements.
- Support clinical trial safety oversight while ensuring adherence to Good Clinical Practices (GCP).
- Develop and deliver training related to clinical trial processes, compliance, and study documentation.
- Resolve complex data, documentation, and regulatory issues escalated by team members.
- Mentor and develop Clinical Research Associates by providing guidance and coaching.
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