Shola Buari
Queens,NY
Summary
Over 5 years’ experience as a Data Manager. Effective Use of
Technology. Experience with but not limited to Medidata Rave,
Inform, Oracle Clinical, OC RDC, J-Review, Oral/Written and
Technological Communication. Liaising with Global Studies
Project Management environment, CRO, and Vendor Management.
Problem Solving Techniques as it relates to critical tasks i.e.
SAE Reconciliation, Lab Reconciliation, Coding, and RECIST.
Performed external data Reconciliation and Manual listing Review.
THERAPEUTIC AREAS
Oncology (Phases I-III) Solid Tumor, Lung, CNS (Phase I and II),
Alzheimer’s Disease, Epilepsy, Infectious Disease, Cardiovascular
(Phases I-III), Medical device.
Professional Experience
Developed and reviewed Case Report Forms and instructions.
Developed and implemented study-specific Data Management Plans.
Write functional specifications for edit checks and study-specific
data reports.
Write and performed user test plans for the data entry screen and
electronic edit checks.
Run, review, and distribute reports to the internal study team and
sponsor.
Created data management timelines based on productivity and
sponsor expectations.
Tracked data processing progress and reviewed data for trends.
Manages changes in scope, budget, revenue recognition, and
participation in monthly internal project reviews.
Monitors and communicates project progress to the customer and
project team including the use of project status reports, and
tracking tools/metrics.
Assists in the contracting process and manages outside vendors
such as EDC vendors, LAB vendors, PK vendors, and IVRS vendors.
Prepared and maintained study specific Data Handling Conventions,
Manual Review Guidelines, and study-specific Data Entry
Guidelines.
Participates in, and presents at internal, customer, third-party,
investigator and KOM (Kick Off meeting) meetings.
Contributes to the Request for Proposal (RFP) and Request for
Information (RFI) process. Prepares input for and participates in
proposal bid defense meetings.
Overview
11
11
years of professional experience
Work History
Clinical Data Manager (Contract)
SK life science
05.2021 - Current
- Brought in to help clean 400 patient Oncology study in advance of FDA Submission under tight timeline.
- High-level, top performer (processing volume and processing accurately) recognized by contract Manager and communicated to Vice President, Data Management.
- Was assessed as top performer in data management department and currently considered for permanent hire.
- Rapid assessment and comprehension of Protocol-to-CDM task implementation (processing discrepancies, writing queries, notes to file).
- Provide input, review, and maintenance of working practices and standards that shift or change during cleaning.
- Perform Discrepancy & Query Management in Oracle Pharmaceutical Application (Oracle Clinical 4.5).
- Provide weekly metric updates during Project Review meetings run by project manager, CDM.
- Applied accurate corrections to clinical databases in accordance with edit check specifications and accurate, one-time responses to queries.
- Perform database lock procedures.
- Responsible for providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions so that databases can be declared clean and locked according to strict performance standards.
- Managed day-to-day operations of assigned study, responsible for timely data management deliverables in cost-effective manner.
- Contributed to the development of Data Management organization through my role within the DM Group.
- Served as the primary CDM contact with CRO and represented CDM on project teams and was responsible for monitoring of data clean-up process performed by CROs through data archival.
Clinical Data Manager I
Worldwide Clinical Trials
03.2019 - 04.2021
- Participated in Patient Profile development and review.
- Attend study team meetings and update team with Data Management progress.
- Served as Project Data Manager for large projects and multiple smaller projects providing professional Data Management input.
- Lead and support clinical and nonclinical special projects.
- Managed relationships with external vendors as well as consultants assisting in study.
- Worked directly with Biostatics and Programmers to provide criteria and specifications for metric reports and validation checks outside normal edit check routines.
- Addressed data discrepancies identified by Project Biostatistician and Study Director to ensure validity.
- Interface with Study team to ensure data meets the requirements for interim analysis.
- Prepared and maintain study specific Data Handling Conventions, Manual Review Guidelines and study specific Data Entry Guidelines.
- Review CRF data for completeness, accuracy, and consistency.
- Identify and resolve data discrepancies and apply obvious correction to CRFs, as appropriate.
- Generated and resolved data queries.
- Update, correct, and review data in clinical database based on resolved data queries.
- Performed Discrepancy Management and data cleanup for EDC studies using Medidata Rave, eClinical EDC application and Oracle Pharmaceutical Application (Oracle Clinical)
- Assisted the Database Administrator with the design of the clinical study database under relevant procedures
- Created dummy data for testing data entry screens and edit checks
- Validate data entry screens and edit check programs
- Organized electronic data loading
- Run batch validations and generate manual queries according to procedures
- Performed QC audits of the clinical trial database against the CRF and resolved queries to establish an accuracy rate
- Performed data tracking and reviewing for in-house review through the use or creation of CRF tracking sheets
- Performed in-house review of CRF for adherence to protocol requirements and project-specific requirements
- Documented and addressed any errors, omissions, or inconsistencies found during data review and worked with project team both internal and external to resolved issues as needed
- Maintained all necessary documentation to support the accuracy of the clinical trial database
- Maintained necessary records documenting all updates to the clinical trial database
- Performed the validation of data fields captured in the database against the CRF when appropriate
- Validated the completeness, accuracy, and consistency of the clinical trial database on an ongoing basis through the use of ad hoc queries
- Accurately entered all lab data, and resolved all test errors.
- Accurate data entry and verification with no difference between database and source documents.
- Adherence to data entry, study-specific guidelines, and instruction accuracy to meet the company’s timelines was extremely important.
- Data entry and verification were done using a split screen system one is the image and the other the database.
- Retrieve and view all CRF pages individually that were already scanned and indexed in the automated workflow system.
Epic Implementation Analyst
Optimum Healthcare IT
03.2013 - 09.2016
- Created workflow testing scripts for the quality assurance team based on electronic medical record (EMR) build.
- Designed and implemented system changes and enhancements with input from nursing leadership for clinical documentation of inpatient departments.
- Assisted and resolved technical and functional problems reported by end users through ServiceNow.
- Built rules for the implementation of a clinical decision unit.
- Streamlined provider and nursing documentation core measures for meaningful use attestation.
- Assisted with the optimization of the organization's inpatient after-visit summary (AVS) report.
- Help to create a flowsheet template (FLT) to record and track patient data and LVN (Navigator) that guides clinicians through specific workflows within the Epic system.
- Created, distributed, and maintained employee linkable templates (EMP), Security class (ECL), role editor (E2R), and specific activities (E2N) for obstetrics, case management, therapies, and ancillary end user.
Education
B.Sc. in Social Science, Economics -
University of Lagos
Skills
- Data validation and verification, CRF Review and Tracking
- Dictionary coding MedDRA 240 and WHODRUG 03 2020
- Review of Ad-Hoc Data Listings
- Work on Phases I, II, and III of clinical trials
- Database testing, and Medical Terminology
- CRF design and Edit checks programming
- Oracle Clinical 45, EDC Medidata Application, OC RDC 453, IBM Clinical, Inform Database
- Database cleaning and discrepancies management
- SAE Reconciliation
- External Data reconciliation – PK, IVRS, and Central Lab
- Knowledge of GCP and HIPAA requirements
References
Available Upon Request
Additional Information
- Windows 98, 2000, XP, Mac OS X.
- Applications: Word, Excel, Access, PowerPoint, Outlook Oracle Clinical, J Review, ServiceNow, Epic.
- Languages: Experienced in SQL; JReview 6.0.6; EDC; and Transact SQL.
Timeline
Clinical Data Manager (Contract)
SK life science
05.2021 - Current
Clinical Data Manager I
Worldwide Clinical Trials
03.2019 - 04.2021
Epic Implementation Analyst
Optimum Healthcare IT
03.2013 - 09.2016
B.Sc. in Social Science, Economics -
University of Lagos
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