Clinical Trial Project Manager
New
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WEP ClinicalClinical Research
Remote, US / Morrisville, North Carolina, 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
- Project ManagementMicrosoft Office
Requirements
- Bachelor’s Degree (health or science field preferred)
- Minimum 5 years’ experience in a Project Manager role within clinical trials or clinical research
- Demonstrated experience managing clinical trials from initiation through close-out
- Strong working knowledge of ICH GCP guidelines and clinical trial processes
- Proven ability to lead cross-functional teams and manage multiple priorities
- Strong organizational, problem-solving, and decision-making skills
- Effective verbal and written communication skills
- Proficiency in Microsoft Office tools
- Ability and willingness to travel as required for business needs
Responsibilities
- Lead the setup, execution, and close-out of clinical trials in compliance with WEP Clinical SOPs, GCP/ICH guidelines, and regulatory requirements.
- Provide day-to-day accountability for the operational delivery of assigned clinical trials.
- Develop and maintain study manuals, operational project plans, timelines, and key performance metrics.
- Ensure proper setup, maintenance, and close-out of eTMF and CTMS systems.
- Serve as project team lead and primary point of contact for internal and external stakeholders.
- Provide oversight and coordination of cross-functional deliverables including monitoring, site management, data management, pharmacovigilance, regulatory, IP supply, and medical writing.
- Act as the primary client contact for clinical trial operations, deliverables, and issue resolution.
- Identify, assess, and proactively manage risks and issues throughout the clinical trial lifecycle.
- Oversee submissions to IRB/ECs and review informed consent forms as required.
- Manage project budgets, scope, financial performance, and vendor deliverables.
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