Sezen Apaydın

Oversees daily line management responsibilities of assigned team. Serves as positive leader and professional role model for respective staff, which may be inclusive of FSP CRAs, FSP CTCs, FSO Country Approval Specialist. As FSP Manager , perform line and functional management activities, guaranteeing adequate performance according to expected requirements, including agreed KPIs, developing corrective plans and follow-ups in case of service issue . Prepare and conduct 1:1 checkpoints, Team Meetings, managing resource feedback and improvements opportunitties discussed in a regular basis.. As Start Up Lead in FSO ,acts as the main point of contact for information and escalation for issues related to start-up in Turkey. Provides local expertise for the execution of site activation activities within Turkey. Focuses on end results using metrics and key performance indicators to manage performance. Manage vendors on-site coordinator activities. Liaise with clients on meetings on issue resolution. Acts as country-client main point of contact in the studies allocated as local project oversight manager. Overall, responsible for oversight and delivery of feasibility and site activation deliverables for Turkey as Start-up Lead. Ultimately responsible for effective resourcing, alignment, training and ongoing professional and technical development for staff. Primary focus on line and performance management of team members.

Prepares, reviews, and coordinates local regulatory submissions (MoH, EC and additional special national local applications as applicable) in alignment with the global submission strategy. Develop and implement the local submission strategy and provided technical expertise and coordination oversight for projects in collaboration with relevant internal departments. Primary contact for investigators and for local regulatory authorities to ensure submissions are manage in a timely manner. Act as a key contact at country level for all submission related activities and participate in Submission Team Meetings, Review Meetings and Project Team meetings as required. Ensure the submission process for sites and studies are aligned to the critical path for site activation. Prepare Regulatory Compliance Review packages. In addition, develop country and site-specific Patient Information Sheet/Informed Consent form documents. Performs several types of submissions including initial submissions, amendments, safety submissions, import license submissions and, customization of ICFs

Prepares, reviews, and coordinates local regulatory submissions (MoH, EC and additional special national local applications as applicable) in alignment with the global submission strategy. Develop and implement the local submission strategy and provided technical expertise and coordination oversight for projects in collaboration with relevant internal departments. Primary contact for investigators and for local regulatory authorities to ensure submissions are manage in a timely manner. Act as a key contact at country level for all submission related activities and participate in Submission Team Meetings, Review Meetings and Project Team meetings as required. Ensure the submission process for sites and studies are aligned to the critical path for site activation. Prepare Regulatory Compliance Review packages. In addition, develop country and site-specific Patient Information Sheet/Informed Consent form documents. Performs several types of submissions including initial submissions, amendments, safety submissions, import license submissions and, customization of ICFs

Performed all aspects of in-house site management in accordance with good clinical practices.Conducted regularly scheduled site management calls with study sites to support the sites’ execution of their study responsibilities.Documented and helped follow to resolution, issues noted during site management contacts. Escalated to management any observed deficiencies or issues in a timely manner and in accordance with study communication and monitoring plan guidelines. Served as the primary study contact for sites. Responded to ad hoc site requests for assistance. Assisted sites with the resolution of outstanding data queries. Provided ongoing site training.

Performed all aspects of in-house site management in accordance with good clinical practices.Conducted regularly scheduled site management calls with study sites to support the sites’ execution of their study responsibilities.Documented and helped follow to resolution, issues noted during site management contacts. Escalated to management any observed deficiencies or issues in a timely manner and in accordance with study communication and monitoring plan guidelines. Served as the primary study contact for sites. Responded to ad hoc site requests for assistance. Assisted sites with the resolution of outstanding data queries. Provided ongoing site training

Provided project administrative support to Clinical Team Managers, Project Managers, and/or CRAs on designated project teams. Responsible for the background administration and preparation for trial set up, monitoring, tracking and close out.

Provided project administrative support to Clinical Team Managers, Project Managers, and/or CRAs on designated project teams. Responsible for the background administration and preparation for trial set up, monitoring, tracking and close out.

Taken responsible for assisting with all aspects of ongoing clinical studies including patient recruitment, Informed Consent procedures, source documentation, reporting, study procedures and laboratory assessments.