Victor Obine
HOUSTON,TX
Summary
Experienced with overseeing clinical trials to ensure adherence to regulatory guidelines and protocols. Utilizes strong project management skills to streamline trial processes and enhance operational efficiency. Track record of effectively managing cross-functional teams and mitigating risks in clinical research.
Overview
7
7
years of professional experience
Work History
Lead Clinical Trial Manager
Merck
Rahway, NJ, USA
08.2023 - Current
- Implemented risk management strategies, effectively minimizing potential threats to the success of clinical trials.
- Supported the preparation of clinical study reports by providing accurate data analysis and interpretation for inclusion in final documentation.
- Spearheaded the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
- Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
- Reduced operational costs through effective budget management, negotiation with vendors, and careful allocation of resources.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
- Prepared detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
- Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
Clinical Trial Manager
IQVIA
Durham, NC, USA
12.2021 - 08.2023
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Followed informed consent processes and maintained records.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Spearheaded the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
- Implemented risk management strategies, effectively minimizing potential threats to the success of clinical trials.
- Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
- Enhanced patient safety by meticulously monitoring clinical trial activities and promptly addressing any issues.
- Collaborated closely with biostatisticians for accurate statistical analysis planning in support of study objectives.
- Evaluated vendor performance regularly to ensure high-quality services were provided throughout the duration of the clinical trial.
- Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
- Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
- Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
- Prepared detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
- Supported the preparation of clinical study reports by providing accurate data analysis and interpretation for inclusion in final documentation.
Associate Clinical Trial Manager
Abivax
Waltham, MA, USA
05.2018 - 11.2021
- Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
- Collected, evaluated, and modeled collected data.
- Complied with research protocols by providing ongoing quality control audits.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Followed informed consent processes and maintained records.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Education
Bachelor Of Science - Industrial Management
Technical University, Varna BG
11.2021
Skills
- Adverse event reporting
- Clinical data management
- Training and mentoring
- Clinical trial oversight
- Audit preparation
- Fluent in english
- Teamwork and collaboration
Therapeutic Areas
- ONCOLOGY
- INFECTIOUS DISEASES
- CARDIOVASCULAR
- RARE DISEASES
- NEUROLOGY
- GASTROENTEROLOGY
Timeline
Lead Clinical Trial Manager
Merck
08.2023 - Current
Clinical Trial Manager
IQVIA
12.2021 - 08.2023
Associate Clinical Trial Manager
Abivax
05.2018 - 11.2021
Bachelor Of Science - Industrial Management
Technical University, Varna BG