Chinedu James Ezeafulukwe
Houston,TX
Summary
A detail-oriented Clinical Data Management professional with over nine (9) years as a clinical data manager across Phase I-III studies. Systematic leader focused on overall accuracy in the administration with demonstrated history of working in the pharmaceutical industry. Provided a solid core and comprehensive data management expertise to data management team to provide efficient, quality data management products that meet customer needs.
Overview
11
11
years of professional experience
Work History
CLINICAL DATA MANAGER II,SR. CLINICAL DATA MANAGER
Care Access
07.2016 - Current
- Responsible for creating the Data Management Plan according to Sponsor SOP & Guideline
- Oversees the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on time and on-budget
- Coordinate the work of clinical data managers, clinical database programmers and medical coders assigned to the project
- Develops & Designs Case Report Forms & Review of sponsor generated CRFs
- Performs Data Validation and Edit Checks
- Work with Project Manager and Monitor for query resolution; abstracts data from necessary sources to complete the EDC and resolved queries
- Responsible for maintaining key clinical study data for reporting to Data Operations Manager and the clinical teams
- Provide status updates on data entry and data quality metrics
- Responsible for overseeing up-to-date and quality data entry into electronic data capture system (EDC) by clinical sites
- Adhere to data security and confidentiality requirements when handling confidential data
- Performs data cleaning and query handling
- Supports preparation of Data Reports
- Ensures adherence to GCP and GDMP and all applicable local and international regulations
CLINICAL DATA ASSOCIATE
PPD Pharmaco
02.2014 - 01.2016
- Assisting in establishing and enforcing departmental standards
- Review and clean data errors for consistency and accuracy according to study guidelines and conventions
- Supports CDM process and application improvements; participate in working groups to develop and implement new processes and applications
- Develop test plans and perform testing to validate databases built by other members of the data management team
- Create User Acceptance Test Scripts from Edit Check Specifications and create dummy data to test edit checks and to test database screen functionality
- Participate in developing documents and review of SOPs, work instructions (WI), and associated documents for CDM
Education
Doctor of Medicine -
Windsor University School Of Medicine
Skills
- Microsoft Office
- Multitasking skills
- Problem recognition
- Problem solving
- Communication skills
- Interpersonal skills
- Ability to work independently
- EDC platforms
- Medidata Rave
- Oracle
- Oracle Inform
- Datalabs
- RDC
- Data interpretation
- Data security
Therapeutic Experiences
- Immunology: Bronchitis
- Cardiology: Coronary Artery Disease, Emphysema, Thromboembolism
- CNS: Parkinson Disease and Multiple Sclerosis
- Oncology: Solid Tumor, Leukemia/AML, Ovarian Cancer
Timeline
CLINICAL DATA MANAGER II,SR. CLINICAL DATA MANAGER
Care Access
07.2016 - Current
CLINICAL DATA ASSOCIATE
PPD Pharmaco
02.2014 - 01.2016
Doctor of Medicine -
Windsor University School Of Medicine
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