Yeliz Kiziltan

Planned and conducted clinical trials, performed feasibility, site selection, initiation, monitoring, co-monitoring and site closure visits, supervised CRAs, CRCs and CROs, evaluated and selected potential CROs and archiving companies, prepared and finalized contracts and agreements. Developed SOPs and Local Implementation Memos. Prepared reports to senior management. Provided guidance, organized investigator meetings and trained internal and external parties.

Conducted clinical trials, organized investigator meetings and trained the investigators. Performed feasibility, initiation, monitoring and close-out visits as planned in the monitoring guidelines. Prepared and finalized site specific contracts. Assumed responsibility of Local Safety Officer.

Coordinated the approval and registration of new products. Ensured appropriate licensing, marketing and legal compliance of products. Prepared clear product labels and patient information leaflets in accordance with local regulations. Decreased the marketing authorization time for new products from 2 years to 1 year in average by correct preparation of registration files, close follow-up and quick responses to health authority requests.

Prepared and updated the registration files according to local regulations. Handled the license renewal procedures for registered products. Coordinated all import license procedures. Managed the design phase of local commercial packages and labels in accordance with local regulations.