Future Opportunity: Clinical Research Start-up Project Manager

Strong understanding of EU CTR and CTIS submission process. Proven experience with CTIS submissions (Part I and Part II). Proven experience as a Start-up PM or Start-up Lead within a CRO. Experience managing multicounty studies. Strong knowledge of ICH-GCP. Strong knowledge of local regulatory frameworks. Strong knowledge of the clinical trial lifecycle. Exceptional organizational, time-management, and communication skills. Ability to work independently and as a team member. Fluent English. Local languages proficiency is an advantage.

Manage oversight of start-up activities from feasibility to site activation. Oversee clinical trial applications and submissions under EU CTR. Supervise collection of site documents for submissions and IP release. Act as the primary client contact during trial start-up. Coordinate trial start-up activities cross-functionally. Develop and maintain SSU strategy and timelines, implementing mitigation strategies.