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Medpace · 18 hours ago

Clinical Trial Project Manager - Infectious Diseases

Irving, TX

Full-time

Onsite

Mid, Senior Level

3+ years exp

Medpace is a leading CRO for Biotech companies, seeking established Clinical Trial Managers and Project Managers focused on Infectious Diseases for their Clinical Trial Management Group in Dallas, TX. The role involves managing day-to-day project operations, serving as the primary Sponsor contact, and overseeing internal project team members and deliverables.

BiotechnologyPharmaceutical

Responsibilities

Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations

Serve as primary Sponsor contact for operational project-specific issues and study deliverables

Maintain in depth knowledge of protocol, therapeutic area, and indication

Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided

Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable

Develop operational project plans

Manage risk assessment and execution

Responsible for management of study vendor; and

Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables