Clinical Trial Project Manager

The Ideal Candidate:

• Adaptable
• Detail-oriented
• Collaborative
• Solutions-focused

What You'll Do:

The level of appointment (e.g., Project Manager II or Senior Project Manager) will be determined based on the candidate’s experience, skills, and demonstrated capabilities during the interview process.
 
 
Principal Duties and 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.
Leadership & Cross-Functional Oversight
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.
Client & Stakeholder Management
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.
Risk & Issue Management
Identify, assess, and proactively manage risks and issues throughout the clinical trial lifecycle.
Implement mitigation strategies and corrective actions where required.
Regulatory & Compliance
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.
Financial & Vendor Management
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.
Documentation & Systems
Maintain accurate and complete trial documentation within internal systems (e.g., SharePoint).
Ensure all trial records meet quality and compliance standards.

What You'll Need:

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
Additional Notes
This role may be filled at different levels depending on experience and demonstrated capability.
Responsibilities may expand in scope with increased seniority and complexity of assigned projects.