Oversee all aspects of clinical trial delivery—from site identification and qualification through setup, monitoring, and closure—ensuring compliance with international guidelines (ICH-GCP) and local regulations
Lead and motivate Local Study Teams (CRAs, CSAs) to deliver clinical trials on time, within budget, and to the highest quality standards
Manage site identification, qualification, setup, initiation, monitoring, and closure activities
Oversee and coordinate monitoring activities from site activation through study closure in accordance with monitoring plans
Ensure compliance with Client Procedural Documents, ICH-GCP guidelines, and local regulations
Develop and maintain risk management plans; proactively identify and resolve complex study issues
Manage trial essential documents, including Informed Consent Forms (ICFs) and regulatory submissions
Prepare and maintain country-level financial Study Management Agreements and budgets
Coordinate with regulatory authorities, ethics committees, and national investigators
Contribute to patient recruitment strategy and maintain relationships with participating investigators
Perform site monitoring as needed to support flexible capacity models

Minimum 3 years of experience in Development Operations (CRA/SrCRA) or related clinical research fields
Proven ability to lead and motivate cross-functional teams to deliver results on time and within budget
Excellent project management, organizational, and communication skills (verbal and written)
Strong knowledge of ICH-GCP guidelines and local regulations
Fluent in Turkish and English
Bachelor's degree in life sciences or related discipline
Excellent attention to detail and ability to prioritize multiple tasks
Good negotiation skills and ability to work effectively with IT systems

Local Study Associate Director

Key skills