Doga Yalcin

- Prepare study-specific Clinical Trial Agreements based on the requirements of study sponsors - Negotiate the contract language with the appropriate party at the sites - Finalize all required contract-related documents and amendments - Prepare, negotiate, analyze, escalate and finalize agreements for external vendor services (Site Management Organizations agreements, radiology agreements etc.) - Work simultaneously on numerous contracts and maintain status tracking tool for individual sites for each study

- Performed the raw material analysis according to USP/EP monographs or the in-house methods - Performed the analytical method evaluation, method development and method validation (Linearity, Recovery, Specificity, LOQ-LOD, Forced degradation, Precision etc.) in accordance with ICH guidelines - Performed the finished product and stability sample testing such as assay, degradation products, content uniformity, residual solvents, dissolution and water determination