Clinical Trial Project Manager

🔥 7 hours ago

🏄 California, Colorado, +7 more states – Remote

🏄 California – Remote ⛰️ Colorado – Remote 🏛️ District of Columbia – Remote 🌺 Hawaii – Remote 🌽 Illinois – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🍂 Massachusetts – Remote ☕ Washington – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

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WEP Clinical

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

Pharmaceuticals • Healthcare Insurance • Biotechnology

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 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, and financial performance.

🎯 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

🏖️ 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