Clinical Trial Project Manager

🕒 July 22

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 46%

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WEP Clinical

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

💼 Consulting

📦 Logistics

💊 Pharmaceuticals

Consulting • Logistics • Pharmaceuticals

WEP Clinical is a Pharmaceutical Services Provider that specializes in Drug Development Programs, Treatment Access Solutions, and Market Access and Commercialization. The company focuses on providing critical support throughout the entire drug development and commercialization journey, helping sponsors advance their medicines and improve patient access. WEP Clinical offers services such as clinical trial services, expanded access programs, post-approval named patient programs, and market access consulting, ensuring that much-needed therapies reach patients worldwide.

📋 Description

• 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 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 • Coordinate cross-functional deliverables across monitoring, site management, data management, pharmacovigilance, regulatory, IP supply, and medical writing • Ensure internal and external teams are trained on study protocols and operational requirements • Act as primary client contact for clinical trial operations, deliverables, and issue resolution • Lead internal and external meetings concerning project status, risks, and timelines • Identify, assess, and manage risks and issues throughout the clinical trial lifecycle • Implement mitigation strategies and corrective actions • Oversee IRB/EC submissions and review informed consent forms as required • Ensure regulatory and internal quality compliance • Collaborate with Quality Assurance on audits, CAPAs, and investigations • Manage project budgets, scope, and financial performance • Oversee vendor performance and deliverables, including invoice review and approval • Review site payments and ensure alignment with Clinical Trial Agreements • Maintain complete trial documentation in internal systems such as SharePoint • Ensure trial records meet quality and compliance standards

🎯 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 • Resume must be in English

🏖️ 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 • Wellness, growth and development initiatives • Team events and employee relationship initiatives