Tai Etim
Katy,Texas
Summary
Experienced Clinical Data Manager with 7 years of expertise supporting all phases of clinical trials. Proven ability to manage complex datasets with precision, ensuring data integrity, compliance, and timely delivery. Strong organizational and project management skills, with a track record of handling multiple studies simultaneously while maintaining high accuracy. Known for being detail-oriented, dependable, and collaborative—committed to continuous learning and taking initiative to support team and project goals. Dedicated to optimizing data processes and contributing to high-quality outcomes in clinical research.
Overview
7
7
years of professional experience
Work History
Clinical Data Manager
RHO (CRO)
09.2023 - Current
- Manage end-to-end data management activities across multiple clinical trials, from start-up through close-out, across various therapeutic areas
- Develop and maintain study-specific documentation including Data Management Plans (DMPs), eCRF Completion Guidelines, Edit Check Specifications, Query Logic, and Work Instructions
- Oversee and execute user acceptance testing (UAT) for EDC systems, ensuring system readiness and alignment with protocol requirements
- Lead data management activities such as eCRF design, database setup, medical coding (e.g., MedDRA, WHODrug), edit check programming, external data reconciliation, and data validation
- Conduct routine and focused data cleaning activities to support clinical analysis, interim reviews, and database lock
- Monitor study progress, prepare status updates, and communicate effectively with project teams, sponsors, and CROs
- Ensure data integrity and compliance for key regulatory submissions, including INDs, NDAs, and Clinical Study Reports (CSRs)
- Participate in cross-functional meetings and contribute to protocol reviews, statistical analysis plans, and other key study documents
- Collaborate closely with Biostatistics, Clinical Operations, Medical Writing, and external vendors to ensure timely and high-quality data delivery
- Serve as the primary data management lead on assigned studies; manage CROs and vendors to ensure deliverables are met according to timelines and quality expectations
- Represent Data Management on clinical trial working groups and provide subject matter expertise throughout the trial lifecycle
- Mentor and train junior data management staff, reviewing their work and ensuring adherence to SOPs and study timelines
- Coordinate internal data review activities and ensure timely completion of in-house quality control
- Review study protocols to define data collection requirements and ensure alignment with EDC, eCOA, and external data integration needs
- Perform comprehensive reviews of eCRF design and data flow to ensure accurate and efficient data capture
Clinical Data manager
TruMinds Clinical
04.2021 - 09.2023
- Managed end-to-end clinical data management activities for multiple clinical trials across various phases
- Led the development and execution of Data Management Plans (DMPs), data review guidelines, and data quality checks aligned with protocol requirements
- Participated in the design, testing, and validation of data collection tools (e.g., EDC, eCOA), ensuring alignment with protocol and regulatory standards
- Oversaw and performed User Acceptance Testing (UAT), including edit check documentation, issue tracking, and summary reporting
- Designed and reviewed eCRFs, annotated CRFs, and CRF Completion Guidelines in collaboration with CRAs, study managers, and biostatisticians
- Provided guidance to clinical sites on data entry procedures and query resolution to ensure high-quality data collection
- Reviewed and maintained clinical data management documents throughout the study lifecycle
- Performed ongoing data cleaning, reconciliation (e.g., SAE, external data), and quality control reviews to ensure data integrity
- Supported database upgrades and migrations, including validation and UAT execution
- Coordinated and led database lock and freeze activities in accordance with company SOPs
- Participated in the review of key study documents, including Clinical Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, and vendor specifications
- Delivered study progress reports and data metrics to internal teams and senior leadership
- Led and participated in study-specific meetings, training sessions, and teleconferences
- Provided training to site and internal teams on EDC systems and eCRF completion at Investigator Meetings and as needed
- Worked closely with cross-functional teams including CRAs, programmers, statisticians, and vendors to ensure timely and accurate study execution
- Contributed to continuous process improvement by identifying data-related issues and collaborating on solutions
Clinical data Associate
TruMinds Clinical
05.2018 - 04.2021
- Assisted in the management of clinical trial data for various studies Conducted data review and cleaning activities
- Developed and maintained study-specific data management tools and documentation
- Participated in study team meetings and contributed to study-related documents
- Worked with the clinical operations team to ensure timely data collection and resolution of data queries
- Assisted with the preparation of clinical study reports and other study-related documents
Education
Bachelor of Science - Health Administration
Texas Southern University
Houston, TX05-2016
Skills
- Solid understanding of clinical trial operations, data lifecycle, and regulatory requirements (FDA, ICH-GCP, CDISC)
- Proficient in clinical data management systems including Medidata Rave, Oracle InForm, and SAS
- Experienced in developing and executing study-specific Data Management Plans (DMPs) aligned with protocol and regulatory standards
- Skilled in EDC system setup, ongoing data review, and query management to ensure clean, audit-ready datasets
- Hands-on experience with data coding (eg, MedDRA, WHODrug), discrepancy management, and data reconciliation
- Strong background in database design, edit check programming, validation, and system testing
- Conducted User Acceptance Testing (UAT) and collaborated with cross-functional teams during system rollouts and updates
- Effective communicator with proven ability to work across clinical teams, vendors, and sponsors to meet project goals and timelines
THERAPEUTIC AREAS
- Endocrinology: Diabetes mellitus Type 1 phase I-II (1year), Acute Kidney Injury Phase I (1 year)
- Cardiovascular: Spinal Cord Phase III (2 years), Medical Device Cardiovascular Phase II (1 year)
- Neurology: Alzheimer's Phase I (2 years), Multiple Sclerosis Phase II (1 year)
- Dermatology: Acne Phase II (2 years), Bacteria Skin Infection Phase I (1 years)
- Oncology: Leukemia Phase I (2 years), AML, ALL, Pancreatic Cancer Phase II (2 years)
- Mental Health: Major depressive Disorder Phase II (2years)
Timeline
Clinical Data Manager
RHO (CRO)
09.2023 - Current
Clinical Data manager
TruMinds Clinical
04.2021 - 09.2023
Clinical data Associate
TruMinds Clinical
05.2018 - 04.2021
Bachelor of Science - Health Administration
Texas Southern University
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