Project Management

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We develop and execute a clinical study plan that meets your study timeline & goals.

The role of Project Manager is crucial for the success of any clinical study. Sierra PMs are prepared to adapt to the ever-changing landscape of the clinical trial environment. We are prepared to immerse into your project and seamlessly become part of your team.

To ensure operational excellence, our team of well-respected Project Managers is comprised of highly skilled, experienced, accountable, motivated individuals. Our team ensures your clinical trial is carefully planned from the start in an extremely detailed manner utilizing study planning tools developed over many years of trial experience.

Our attentive experts will oversee enrollment, manage IRB submissions and approvals, manage CRAs and monitoring progress, track safety events and protocol deviations, resolve site-specific or general study issues, facilitate team meetings, manage query status, write study newsletters as well as many other routine study management activities.

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Project management & study oversight Site selection Study planning & tracking Develop study documents & agreements including regulatory logs Monitoring plan development IRB Submissions IRB correspondence & approval oversight Team training Facilitate team meetings; create agendas and minutes

CRA Management Monitoring Report review & approval Study tracking tools Management of subject enrollment Clinical review of study data Query management Study progress reports Study newsletters Site & team correspondence

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