George Didita
5 Magrath Street, Kellyville, Sydney,NSW
Summary
Accomplished Senior Clinical Research Associate at MSD Australia with expertise in clinical trial management and regulatory compliance. Proven track record in ensuring data integrity and enhancing protocol adherence, while mentoring junior associates. Adept at collaborating with sponsors to meet project milestones and drive successful trial outcomes.
Overview
13
13
years of professional experience
Work History
Senior Clinical Research Associate
MSD Australia
Sydney
06.2017 - 03.2025
- Provided guidance to junior clinical research associates regarding protocol adherence, CRF completion and other aspects of the clinical trial process.
- Checked electronic data capturing systems for integrity and compliance.
- Collaborated with sponsors on developing project timelines, budgets and milestones.
- Performed source document verification, data query resolution and reconciliation of discrepancies.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
Clinical Research Associate
Novartis Australia
, NSW
01.2016 - 06.2017
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
Senior Clinical Research Associate
ICON Clinical Research Romania
Bucharest, Romania
12.2011 - 07.2015
- Checked electronic data capturing systems for integrity and compliance.
- Collaborated with sponsors on developing project timelines, budgets and milestones.
- Performed source document verification, data query resolution and reconciliation of discrepancies.
- Monitored safety events reported by investigators or found during monitoring visits.
Education
Bachelor of Medicine - Medical Doctor
University Ovidius Constanta
Romania06-2003
Skills
- Clinical trial management
- Data integrity checks
- Source document verification
- Regulatory compliance
- Protocol development
- Safety monitoring
Languages
Romanian
Native/ Bilingual
Timeline
Senior Clinical Research Associate
MSD Australia
06.2017 - 03.2025
Clinical Research Associate
Novartis Australia
01.2016 - 06.2017
Senior Clinical Research Associate
ICON Clinical Research Romania
12.2011 - 07.2015
Bachelor of Medicine - Medical Doctor
University Ovidius Constanta
Similar Profiles
Carol KatsabirisCarol Katsabiris
Hospital Account Manager at MSD AustraliaHospital Account Manager at MSD Australia
Mark Del CuoreMark Del Cuore
Market Access Manager at MSD AustraliaMarket Access Manager at MSD Australia
Amanda Chacón FonsecaAmanda Chacón Fonseca
Order To Cash Senior Analyst at MSD de Costa RicaOrder To Cash Senior Analyst at MSD de Costa Rica