Burcu Küçükbabacık Email & Phone Number

Istanbul, Turkey

Istanbul, Turkey

• Oversight of country and site level global clinical development activities as country sponsor representative• Follow country and site feasibility; study start-up, conduct, and close-out activities outsourced to external partner CRO for global programs across different Therapeutic Areas • Ensures quality and ICH/GCP/local regulatory requirements are observed • Proactively communication and collaboration with key internal key steakholders Medical; Regulatory and Pharmacovigilance… Show more • Oversight of country and site level global clinical development activities as country sponsor representative• Follow country and site feasibility; study start-up, conduct, and close-out activities outsourced to external partner CRO for global programs across different Therapeutic Areas • Ensures quality and ICH/GCP/local regulatory requirements are observed • Proactively communication and collaboration with key internal key steakholders Medical; Regulatory and Pharmacovigilance department as a leader of country R&D council. • Understand and develop country region clinical operation potential and advocate country / region for potential future trials. Show less

Istanbul, Turkey

• Oversight of country and site level global clinical development activities as country sponsor representative• Follow country and site feasibility; study start-up, conduct, and close-out activities outsourced to external partner CRO for global programs across different Therapeutic Areas • Ensures quality and ICH/GCP/local regulatory requirements are observed • Proactively communication and collaboration with key internal key steakholders Medical; Regulatory and Pharmacovigilance… Show more • Oversight of country and site level global clinical development activities as country sponsor representative• Follow country and site feasibility; study start-up, conduct, and close-out activities outsourced to external partner CRO for global programs across different Therapeutic Areas • Ensures quality and ICH/GCP/local regulatory requirements are observed • Proactively communication and collaboration with key internal key steakholders Medical; Regulatory and Pharmacovigilance department as a leader of country R&D council. • Understand and develop country region clinical operation potential and advocate country / region for potential future trials. Show less

Istanbul Area, Turkey

Istanbul, Turkey

Istanbul, Turkey

• To manage the assigned clinical trials in accordance with all relevant processes and procedures & applicable clinical research regulations; to ensure the delivery of data within the agreed parameters (quality/ time / budget),• To manage the reporting CRAs and to manage CRO and vendors• To select the study centers; to participate and to manage the study initiations,• To prepare the study budget; to plan department budget and to handle the assigned overall budget of clinical trial… Show more • To manage the assigned clinical trials in accordance with all relevant processes and procedures & applicable clinical research regulations; to ensure the delivery of data within the agreed parameters (quality/ time / budget),• To manage the reporting CRAs and to manage CRO and vendors• To select the study centers; to participate and to manage the study initiations,• To prepare the study budget; to plan department budget and to handle the assigned overall budget of clinical trial department • As a member of Lauch Readiness team to provide data/knowledge for launch team; share acces programs experience and development activities Show less

Istanbul, Turkey

Bs, Chemical Engineering

Executive Mba, Business, Management, Marketing, And Related Support Services, 3,33

Activities and Societies: brand management, finance management, entrepreneurship

Associate'S Degree, Child Development, 3.5/4.0