Study Start Up Project Manager – FSP

📋 Description

• Define, develop, and implement the global start-up project strategy by collaborating with roles across GSSO, CD&O, Global Regulatory Submissions, and other necessary departments.

• Assume full responsibility for small to medium-sized studies conducted within a single country or region.

• Lead start-up meetings to ensure alignment between site selection and activation activities performed by country-level start-up roles, in accordance with the approved trial optimization plan.

• Responsible for the quality and completeness of start-up timeline plans at the study, country, and site levels within an enterprise project management (EPM) system.

• Coordinate and monitor the progress of study-specific or country-specific tasks that must be completed for site activations.

• Expertly incorporate the requirements of protocol amendments to achieve site activations as planned.

• Serve as a key escalation point for site activation-related issues raised by country-level start-up roles.

• Continuously evaluate current and future workloads to proactively anticipate and solve problems.

⛳️ Requirements

• Extensive experience in global start-up clinical trial/study management.

• Thorough working knowledge of Good Clinical Practices, monitoring, and clinical and regulatory operations.

• In-depth understanding of clinical trial methodology.

• Proven start-up experience.

• Demonstrated project management skills.

• Experience with country or regional start-up in the countries of responsibility across at least two major therapeutic areas.

• Technical proficiency in using software (both off-the-shelf and custom) for managing clinical studies, with strong abilities in utilizing reporting systems (dashboards and related basic data analysis) to understand and communicate status.

• Capability to apply basic generative artificial intelligence techniques in daily tasks.

• Fluency in English is mandatory.

• A scientific or technical degree is preferred.

• A BS/BA with 5 years of relevant experience is required.

• An MS/PhD with 3 years of relevant experience is also acceptable.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off