Clinical Trial Lead

About the role

Lead the planning, execution and oversight of designated clinical studies, from initiation through study closure. Ensure compliance with quality standards, regulatory requirements, timelines, and budget commitments.

Responsibilities

• Independent development of study related documents including but not limited to protocol, study manuals, project tools, project plans, tracking tools, and informed consent forms templates.
• Develops clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); managing interface with CROs in cooperation with line functions; ensuring vendors meet quality standards in their work for the trial; contributing to the development/amendment of vendor contracts.
• Oversees efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operation staff and departments as appropriate.
• Leads study management team meetings and teleconferences.
• Serves as main study contact for the cross functional team, CROs, vendors (as applicable) and acts as point of contact for escalation of issues and creation of mitigation plans.
• Chair of the global cross-functional Clinical Trial Team (CTT), develop agenda and run meetings.
• Key contributor to the Data Review Plan; manages data flow and data cleaning process.
• Key contributor to the TMF Plan.
• Manages study-specific vendors, as appropriate.
• Supports the Clinical Program Lead with the development, management and tracking of the trial level budget(s) including approving invoices, forecast, and annual budget reviews.
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