Clinical Trial Project Manager
New
W
WEP ClinicalClinical research
Remote, USFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- Minimum 5 years’ experience in a Project Manager role within clinical trials or clinical research
- Required Skills
- Cross-functional Team LeadershipMicrosoft OfficeRisk Management
Requirements
- Hold a bachelor’s degree; a health or science field is preferred.
- Have a minimum of 5 years’ experience in a Project Manager role within clinical trials or clinical research.
- Demonstrate experience managing clinical trials from initiation through close-out.
- Have strong working knowledge of ICH GCP guidelines and clinical trial processes.
- Demonstrate ability to lead cross-functional teams and manage multiple priorities.
- Have strong organizational, problem-solving, and decision-making skills.
- Have effective verbal and written communication skills.
- Be proficient in Microsoft Office tools.
- Be willing and able to travel as required for business needs.
Responsibilities
- Lead the setup, execution, and close-out of clinical trials in compliance with SOPs, GCP/ICH guidelines, and regulatory requirements.
- Manage day-to-day operational delivery, study plans, timelines, and key performance metrics.
- Set up, maintain, and close out eTMF and CTMS systems.
- Lead project teams and coordinate cross-functional deliverables across monitoring, site management, data management, pharmacovigilance, regulatory, IP supply, and medical writing.
- Serve as the primary client contact and lead meetings on project status, risks, and timelines.
- Identify and manage trial risks and issues, implementing mitigation strategies and corrective actions.
- Oversee IRB/EC submissions and review informed consent forms as required; support audits, CAPAs, and investigations with Quality Assurance.
- Manage project budgets, scope, financial performance, vendors, invoices, and site payments.
- Maintain complete trial documentation and ensure records meet quality and compliance standards.
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