Lead Local Study Teams (LSTs) to deliver components of clinical studies according to budget and timelines
Perform site monitoring as needed to support the flexible capacity model
Ensure that sites are identified, set up, monitored, closed, and documentation archived
Optimize performance of Local Study Teams ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations
Coordinate site selection process by identifying potential sites/investigators and conducting Site Qualification Visits
Ensure timely submission of application/documents to EC/IRB and Regulatory Authority
Prepare and maintain study budget in Sponsor clinical studies financial system
Manage monitoring activities from site activation through to study closure
Proactively identify risks and facilitate resolution of complex study problems
Organize regular Local Study Team meetings
Communicate and coordinate regularly with stakeholders on recruitment and study matters.
Ensures compliance with Sponsor´s Code of Ethics and company policies.

Bachelor degree in related Life Science discipline
Minimum 3 years of experience in Clinical Monitoring (CRA, Sr CRA)
Good knowledge of international guidelines ICH GCP as well as relevant local regulations
Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality
Good medical knowledge of Oncology therapeutic area
Excellent understanding of the Clinical Study Process including monitoring
Very good understanding of the Study Drug Handling Process and the Data Management Process
Excellent project management skills
Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills
Excellent knowledge of spoken and written English and Turkish language
Good ability to learn and to adapt to work with IT systems
Proven ability to work independently with tasks allocated.

Local Study Associate Director

Key skills