Clinical Trial Manager/Project Manager
New
US-East-Coast RemoteFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 2+ years
- Required Skills
- Project ManagementBudget management
Requirements
- Bachelor's degree in a health-related field or equivalent work experience.
- Licensed healthcare professional status (e.g., registered nurse) is an acceptable alternative to a degree.
- Minimum of 2+ years of clinical research project management experience.
- Proficiency in managing clinical trial start-up and monitoring execution.
- Ability to manage cross-functional teams and client expectations.
- Knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience in budget oversight and project financial forecasting.
- Strong risk mitigation and problem-solving skills.
- Experience with electronic Trial Master File (eTMF) compliance.
- Ability to collaborate effectively with Quality Assurance and internal stakeholders.
Responsibilities
- Lead and manage clinical study start-up and monitoring activities.
- Serve as primary point of contact for sponsors, study sites, and CRAs.
- Monitor study progress, track metrics, and conduct trip report reviews.
- Manage project budgets, forecast units and hours, and identify out-of-scope tasks.
- Collaborate with Quality Assurance to ensure trial compliance and audit readiness.
- Facilitate cross-functional communication and resolve project risks or issues.
- Review essential documents in the electronic Trial Master File (eTMF).
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