Octavia Paunescu
Bucharest
Summary
Clinical Trial Manager with regional and global experience in the pharmaceutical industry, specializing in Phase 0-IV trials. Extensive expertise in ICH GCP, Electronic Data Capture (EDC), Clinical Research, and Clinical Trials Operations. Proven history of working in Oncology, Rare Diseases, and Infectious Diseases, with a deep understanding of clinical trial management, CRO management, and regulatory compliance. A results-driven professional with a Senior Specialist degree in Clinical Pharmacy from Universitatea de Medicină și Farmacie „Carol Davila” din Bucuresti.
Overview
11
11
years of professional experience
Work History
Clinical Trial Manager
Syneos Health
08.2022 - Current
- Responsible for oversight of site management, clinical monitoring, and central monitoring deliverables, ensuring patient safety, protocol/GCP/regulatory compliance, and data integrity throughout the trial
- Lead the execution and risk mitigation of clinical trial deliverables, collaborating with cross-functional teams to ensure study milestones are met
- Review study scope, budget, and protocols, and ensure the clinical project team is aligned with contractual obligations
- Participate in key meetings, including study kick-offs, and serve as an escalation point for communication with investigator site staff
- Develop and maintain clinical study tools, including the Clinical Monitoring Plan (CMP), and lead ongoing training for the study team
- Monitor and review site and central monitoring documentation to ensure they meet quality standards, ensuring compliance with protocol/GCP and patient safety
- Led the Global Protocol Deviations calls internally and with the client
- Repeatedly led the Global Clinical Trial Managers activities during their absence (including the internal and the client meetings) acting as the main back-up
Regional Clinical Lead
Syneos Health
09.2021 - 08.2022
- Regional lead for multiple countries with responsibility for coordinating and overseeing clinical trials in various therapeutic areas
- Led a team of Clinical Research Associates (CRAs), ensuring efficient study setup and progress, including oversight of site activations, subject enrollments, and data collection
- Collaborated with functional teams, including regulatory and safety departments, to ensure smooth trial execution and compliance with global standards
Local Trial Manager
Johnson & Johnson while working for Quintiles
09.2013 - 01.2015
- Regional lead for Romania with responsibility for coordinating and overseeing a Phase 0 clinical trial in Infectious Diseases
- Trained Clinical Research Associates (CRAs), has developed study documentation such as: Laboratory Manual, Informed Consent Forms ensuring efficient study setup and progress
- Collaborated with project leads, including regulatory and safety departments, to ensure smooth trial execution and compliance with global standards
Education
Post Graduate Diploma - Pharmacy
University of Medicine and Pharmacy "Carol Davila"
Romania01.2014
Master’s - Management
Academy of Economic Studies, Faculty of Management
Romania01.2012
Bachelor’s - Marketing
Academy of Economic Studies, Faculty of Marketing
Romania01.2010
Residency - Pharmacy
University of Medicine and Pharmacy "Carol Davila"
Romania01.2009
Licensed Pharmacist -
University of Medicine and Pharmacy "Carol Davila"
Romania01.2003
Skills
- Clinical Site Management
- Clinical Trial Monitoring
- Data Analysis & Reporting
- Risk Mitigation Strategies
- Study Planning & Coordination
- Protocol & GCP Compliance
- Problem-Solving & Strategic Thinking
- Cross-functional Collaboration
- Team Leadership & Training
- Project Management & Budgeting
- Client Liaison & Stakeholder Communication
- High-Quality Standards & Analytical Skills
- Site Selection & Monitoring
- Performance Metrics & Project Deliverables
Awards Recognition
Project Excellence Team Award, COO, 07/01/24
References
Available upon request.
Languages
English Proficient
Therapeutic Area Expertise
0, Romania, II, Bulgaria, Brazil, India, Hungary, Romania, Turkey, Ukraine, US, III, Argentina, Chile, Colombia, Croatia, Austria, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Serbia, Spain, UK, US, III, Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Japan, Korea, Mexico, Netherlands, Poland, Romania, Russia, Singapore, Spain, Switzerland, Taiwan, UK, US
Professional Development
- Clinical Research Project Management, Viares, 01/01/25
- Clinical Leaders Preparation Program, Syneos Health, 06/01/21
- NIDA ICH GCP E6 R2 Training, 07/01/24
- Licensed Neuro-linguistic Programming Trainer, IANLP, 09/01/19
- Licensed Neuro-linguistic Programming Master, IANLP, 10/01/18
- Project Management Professional Preparation, 07/01/18
- Train the Trainer Certification, 04/01/18
- Advanced Excel Level I & II, 09/01/17 & 08/01/17
- Completed PPD CRA Foundation Course, Cambridge, UK, 05/01/09
- Introductory Course for Monitors Training, ABCRO, 12/01/08
Timeline
Clinical Trial Manager
Syneos Health
08.2022 - Current
Regional Clinical Lead
Syneos Health
09.2021 - 08.2022
Local Trial Manager
Johnson & Johnson while working for Quintiles
09.2013 - 01.2015
Post Graduate Diploma - Pharmacy
University of Medicine and Pharmacy "Carol Davila"
Master’s - Management
Academy of Economic Studies, Faculty of Management
Bachelor’s - Marketing
Academy of Economic Studies, Faculty of Marketing
Residency - Pharmacy
University of Medicine and Pharmacy "Carol Davila"
Licensed Pharmacist -
University of Medicine and Pharmacy "Carol Davila"
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