Note: The job is a remote job and is open to candidates in USA. WEP Clinical is a mission-driven organization that delivers clinical trial, access, and market access solutions to support drug development and improve patient access to treatments. The Clinical Trial Project Manager leads the setup, execution, and close-out of clinical trials, ensuring patient safety, data integrity, regulatory compliance, and delivery within scope, timelines, and budget.
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
- 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
- • Adaptable
- • Detail-oriented
- • Collaborative
- • Solutions-focused
- • 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
- •Location eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia. •
Benefits
- Medical, dental, and vision insurance
- FSA, HSA
- Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
- Group short-term and long-term disability insurance
- Group Life Insurance
- 401K safe harbor plan and company match
- Paid vacation, holiday, sick and volunteer time
- Paid maternity & paternity leave
- Initiatives to encourage wellness, growth and development, and team relationships
- An inclusive, supportive environment committed to helping people grow and succeed
Company Overview