Doga Yalcin

• Assembled submission packages for regulatory authorities following ICH/GCP and local regulations. • Managed Critical Document Packages (CDP) for site activation. • Performed timely and accurate progress data entry of all collected site documents and activities into tracking systems and tools.

• Prepared and submitted regulatory documents (clinical trial applications, ethics committee submissions). • Coordinated stakeholders to obtain approvals for study initiation. • Maintained accurate records of submissions and approvals. • Supported study teams in developing protocols and study documents.

-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/or 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