EDC(Open Clinica)
VICTUS AMAEFULE
KATY,TEXAS
Summary
Detail-oriented Clinical Data Manager with over 6 years of experience in managing clinical trial data, ensuring data integrity, and maintaining compliance with regulatory standards. Proven ability to lead data management teams, develop data collection systems, and collaborate with cross-functional teams to support successful clinical outcomes.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Clinical Data Coordinator
[Your Previous Employer]
- Managed data entry and validation for clinical studies, ensuring accuracy and completeness of clinical data
- Assisted in the development and maintenance of standard operating procedures (SOPs) for data management processes
- Worked closely with clinical teams to track patient enrollment and data collection timelines
- Supported audits and inspections, preparing documentation and reports as needed.
Clinical Trials Assistant
[Another Previous Employer]
- Provided administrative support for clinical trial operations, including documentation and data management
- Assisted in the collection and maintenance of clinical trial data, ensuring compliance with protocols and timelines
- Coordinated communication between study sites and the central office, facilitating data transfer and query resolution.
Clinical Data Manager
[Your Current or Most Recent Employer]
05.2022 - Current
- Lead the design and implementation of clinical databases for multiple Phase II and III clinical trials
- Collaborate with clinical research teams to develop data collection tools and ensure adherence to study protocols
- Conduct data validation and cleaning processes, resolving discrepancies to maintain high data quality
- Generate and review statistical reports, ensuring compliance with regulatory requirements
- Mentor and train junior data management staff on data handling procedures and best practices.
Education
Associate of Applied Science - Industrial Chemistry
University of Benin
Benin City09-2004
Skills
- SQL
- Excel
- Access
- SAS
- Oracle Clinical
- Medidata Rave
- EDC Systems
- Clinical Trial Management
- Data Analysis & Interpretation
- Regulatory Compliance (FDA, EMEA)
- Database Design & Management
- Clinical Data Standards (CDISC, SDTM)
- SAS Programming & Statistical Analysis
- Quality Assurance & Control
- Project Management
- Database Design
- Data Validation
- Clinical Research
- Patient confidentiality
- Data Security
- SQL query writing
- Protocol development
- Project management experience
- Data reporting
- Data Modeling
- Data integration
- Database finalization
- Data oversight
- Data Collection
- Data Governance
- Data monitoring
- Database designing
Certification
- Certified Clinical Data Manager (CCDM), [Issuing Organization], [Year]
- Good Clinical Practice (GCP) Certification, [Issuing Organization], [Year]
Affiliations
- Member, Society for Clinical Data Management (SCDM)
- Member, Association of Clinical Research Professionals (ACRP)
Software
ETMF and SAS
Veeva Vault
Python
Tableau
Power BI
SQL
Microsoft Azure
Microsoft Excel
Timeline
Clinical Data Manager
[Your Current or Most Recent Employer]
05.2022 - Current
Clinical Data Coordinator
[Your Previous Employer]
Clinical Trials Assistant
[Another Previous Employer]
- Certified Clinical Data Manager (CCDM), [Issuing Organization], [Year]
- Good Clinical Practice (GCP) Certification, [Issuing Organization], [Year]
Associate of Applied Science - Industrial Chemistry
University of Benin
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