Project Manager

• Serve as the project team lead and primary client contact for clinical trials, overseeing operations, deliverables, and issue resolution.
• Manage the setup, execution, and close-out of trials in compliance with WEP Clinical SOPs, GCP/ICH guidelines, and regulatory requirements.
• Provide accountability for day-to-day trial operations as defined by the contract and applicable regulations.
• Develop and maintain study manuals, operational project plans, timelines, and performance metrics.
• Assess countries and sites for feasibility to conduct clinical trials.
• Lead and coordinate cross-functional project teams (e.g., monitoring, site management, data management, PV, medical writing, regulatory, training, IP supply).
• Ensure internal and external teams are properly trained on operational aspects and therapeutic areas.
• Identify, assess, mitigate, and manage risks throughout the project lifecycle.
• Manage submissions to IRB/ECs, review local informed consent forms, and ensure accurate trial documentation (eTMF, CTMS, shared systems).
• Coordinate and lead internal and external meetings and teleconferences, ensuring effective communication across teams.
• Oversee vendor management, quality standards, project budgets, scope of work, and review/approval of vendor and site invoices/payments.
• Liaise with Quality Assurance to support audits, investigations, and CAPAs.

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