Remote Clinical Trial Project Manager

WEP Clinical; Morrisville (NC); On-site; USD 95,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401K plan with company match

Paid vacation and holidays

Parental leave

Job summary

WEP Clinical in Morrisville, NC is seeking a Clinical Project Manager to lead the setup, execution, and close-out of clinical trials, ensuring patient safety, data integrity, and regulatory compliance.

The role requires 5+ years in clinical trial project management, a BA/BS in health or science, and strong cross-functional leadership, communication, and problem-solving skills. Travel may be required, and the position offers a comprehensive benefits package.

Qualifications

• Bachelor’s degree in health or science field.
• 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 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 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.
• Ensure internal and external teams are appropriately trained on study protocols and operational requirements.
• Act as the primary client contact for clinical trial operations, deliverables, and issue resolution.
• Lead internal and external meetings, ensuring alignment on project status, risks, and timelines.
• Identify, assess, and proactively manage risks and issues throughout the clinical trial lifecycle.
• Implement mitigation strategies and corrective actions where required.
• Oversee submissions to IRB/ECs and review informed consent forms as required.
• Ensure compliance with regulatory requirements and internal quality standards.
• Collaborate with Quality Assurance to support audits, CAPAs, and investigations as appropriate.
• Manage project budgets, scope, and financial performance.
• Oversee vendor performance and deliverables, including review and approval of invoices.
• Review site payments and ensure alignment with Clinical Trial Agreements.
• Maintain accurate and complete trial documentation within internal systems (e.g., SharePoint).
• Ensure all trial records meet quality and compliance standards.

Skills

Project management

Cross-functional leadership

Regulatory awareness

Problem-solving

Communication skills

Education

Bachelor's Degree in health or science

Tools

Microsoft Office

Job description

WEP Clinical in Morrisville, NC is seeking a Clinical Project Manager to lead the setup, execution, and close-out of clinical trials, ensuring patient safety, data integrity, and regulatory compliance.

The role requires 5+ years in clinical trial project management, a BA/BS in health or science, and strong cross-functional leadership, communication, and problem-solving skills. Travel may be required, and the position offers a comprehensive benefits package.