Adaeze Obi

• All responsibilities listed under Manager Clinical Data Management role.
• Participate in vendor selection and management process.
• Participate and contribute towards NDA submission preparation, from Data Management aspect.
• Recruited and hired top-performing individuals bringing undeniable experience and wealth of skills to organization.
• Created data management plans and provided input on study designs.
• Participated in quality assurance reviews to verify accuracy and reliability of data.
• Enforced strict data validation rules to maintain accuracy and completeness of clinical data.
• Managed system for secure storage, transmission and manipulation of clinical data.
• Developed comprehensive data dictionary for efficient and accurate data tracking.
• Built complex data analysis reports and provided timely feedback to stakeholders.

TA experience: Oncology,Endocrinology (diabetes),Respiratory , Dermatology and Infections.

• Collaborated closely with physicians and nursing staff to improve quality of patient records documentation.
• Participated in committees to discuss electronic health records and methods to improve overall workflows.
• Implemented new coding and billing procedures that helped alleviate number of denied claims from insurance carriers.
• Collaborated with medical teams to create uniform standards for clinical data reporting.
• Enforced strict data validation rules to maintain accuracy and completeness of clinical data.
• Worked with programming to coordinate Study Data Tabulation Model maps.
• Develop, review and revise Data Management SOPs as needed
• Review and approve study documents (including but not limited to Protocol synopsis,Protocol drafts, CRF and CCG drafts, DMP and SAE reconciliation plan.
• Oversight of DM activities outsourced to Vendors
• Strengthened communication skills through regular interactions with others.
• Worked well in team setting, providing support and guidance.
• Self-motivated, with strong sense of personal responsibility.

TA Experience : Oncology, Pharmaceuticals.

• Collaborated closely with physicians and nursing staff to improve quality of patient records documentation.
• Participated in committees to discuss electronic health records and methods to improve overall workflows.
• Collaborated with medical teams to create uniform standards for clinical data reporting.
• Enforced strict data validation rules to maintain accuracy and completeness of clinical data.
• Managed system for secure storage, transmission and manipulation of clinical data.
• Developed comprehensive data dictionary for efficient and accurate data tracking.
• Worked with programming to coordinate Study Data Tabulation Model maps.
• Assisted with database upgrades and migrations by performing user acceptance testing.
• Built complex data analysis reports and provided timely feedback to stakeholders.
• Skilled at working independently and collaboratively in team environment.
• Self-motivated, with strong sense of personal responsibility.
• Worked well in team setting, providing support and guidance.
• Excellent communication skills, both verbal and written.
• Proved successful working within tight deadlines and fast-paced environment.
• Strengthened communication skills through regular interactions with others.
• Used critical thinking to break down problems, evaluate solutions and make decisions.
• Participated in team projects, demonstrating ability to work collaboratively and effectively.
• Identified issues, analyzed information and provided solutions to problems.
• Organized and detail-oriented with strong work ethic.