• Considered as the primary point of contact for the investigative site. • Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program. • Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol. • Advanced understanding of site engagement and ability to customize site engagement strategy for assigned studies. • Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy. • Evaluate and ensure effective recruitment and retention techniques/plans based on patient disease journey. • Develop solid knowledge of therapeutic area, asset, and clinical landscape to enable successful patient recruitment. • Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting.

• Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study • Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period. • Trains investigational site staff as necessary • When applicable, supports preparation of regulatory and / or EC submissions • Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.

• Conduct and report all types of onsite monitoring visits • Be involved in study startup • Perform CRF review, source document verification and query resolution • Be responsible for site communication and management • Be a point of contact for in-house support services and vendors • Communicate with internal project teams regarding study progress • Be involved in site identification process • Support regulatory team in preparing documents for study submissions • Prepare for and participate in audits and inspections

• Delivering clinical trial monitoring work to a high standard • Working closely with your team and stakeholders • Coordinating all activities for setting up and monitoring a study • Completing accurate study status reports and maintaining study documentation • Running sponsor generated queries efficiently and taking responsibility for study cost efficiency • Participating in the preparation and review of study documentation and feasibility studies for new proposals as required • Developing and maintaining strong, collaborative relationships with key stakeholders, clinical investigators, and site staff • Ensuring compliance with ICON's procedures, protocols, and regulatory requirements to ensure patient safety