Devrim Sabuncuoglu

Full services Clinical Operation Leadership | Consulting | GCP-Auditing | Clinical Project Management | Oversight Monitoring Management | Regulatory and Start-up | Budget & Contract Management| Real World Evidence | PhaseI-IV/Bioequivalence/Medical Device studies

Country Head & Clinical Research Manager - line management & functional management

Responsible from all activities within Turkey - Bioequivalence, Bioanalytical, Clinical Phase Trials, Clinical Operations

Responsible from managing related laboratory units(Core, Specific, Microbiology, Atomic abs., Molecular Biology Labs) for the studies of all types of Clinical Trials. Assures adherence to Good Laboratory Practice, investigator integrity, subject confidentiality, and compliance with protocol and all related study procedures.

Senior Clinical Research Associate for several projects. Responsible for monitoring all types of clinical trials. Assures adherence to Good Clinical Practice, investigator integrity, and compliance with protocol and all study procedures. Considerable on-site commitment at investigational site. *Responsibilities: Site Selection, Study Initiation, Study monitoring (on-site monitoring, in-house monitoring), Study Termination, Performs administrative duties including attendance at clinical monitoring

Responsible for management of multi-service projects, third party suppliers, customer & any customer affiliates (as by project scope), *The overall project management (deliverable, quality of deliverable, timeline and budget) of a project ensuring maximum effectiveness. *Analyze potential issues and risks that affect the project, particularly those that affect more than one operational area. *Reviews and develops solutions, action plans with operations for consideration/management as appropriate.

Clinical Research Associate for international projects. Performed selection, pre-study initiation, interim monitoring and close-out visits. Document owner and author reviewer and approver – Local Monitoring requirements in Turkey

Biotechnology, Genetics