Colette Koti

•Monitoring/site management of Phase I‐IV studies •Effective communication with sites •Proactively identifies site issues, develops corrective/preventative actions plan •Ensures sites training; protocol, regulatory guidelines/study procedures •Develops enrollment strategy •Reviews electronic data, performs SDV •Ensures eTMF is current and up to date •Attends Investigator meetings and others •Performs feasibility •Remote Accumulated Data Review-RADAR •Risk Based Monitoring •Mentors/ trains CRMs/CRAs

•A member of the Post Approval study implementation team with site management responsibilities •Responsible for the remote startup, management and closeout of sites participating in peri‐ and post‐approval projects •Phase I - IV, patient registries, safety surveillance studies, health outcomes studies and late phase product programs. •Involved in feasibility: identify/select potential investigators who will be responsible for conducting the trial at site •Mentored and trained less experienced staff.

•Supported Project Manager to ensure the contracted services and expectations of a clinical study are carried out in accordance with the executed contract/ Customer’s expectations •Tracked/analyzed project details and maintained internal systems for assigned projects within a therapeutic area •Management of TMF/Reconciliations •Submissions /management of regulatory authority applications/approvals •Quick Start Camps - supported the PM in the drafting of project plans •TMF Rescue in various European TMF