• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects • Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded • Conduct study initiation visits (SIVs) • Ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements

• 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