Study Start-up Lead

Start-Up Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

• The Study Start-up/Site Activation Lead is responsible at country level for managing and conducting start-up activities in compliance with the client procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.

• The Study Start-up/Site Activation Lead will prepare, review, track and manage site regulatory documentation at country and site level,  and will maintain, review and report on site performance metrics.

• The Study Start-up/Site Activation Lead works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner

Typical Accountabilities:

• Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;
• Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
• Actively participates in Local Study Team (LST) meetings.

• Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
• Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
• Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, client SOPs and local requirements. Support QC checks performed by Trial Manager or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with client SOPs.
• Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Are you a current ICON Employee? Please click here to apply