Clinical Data Research
Resume:
WALTER T. MOORE III
WALTER T. MOORE III
RALEIGH, NC 27616
******@*****.***
Professional Summary:
Experience in the clinical research and Notary industry. Depth of experience managing clinical trials which consist of all Phase I, II, III, and IV trials including the JReview JReviewWeb, Data Visualizations and Data listings, study set up, data cleaning, database close-out and other associated tasks. Proficient in regulatory standards (ICH/FDA, CDISC/CDASH, 21 CFR Part 11) with expertise in eCRF and database design, vendor oversight, data cleaning activities and cross-functional collaboration.
Technical Skills:
Therapeutic Area Experience: Solid Tumors and Hematologic Oncology trials, Cardiovascular and Respiratory.
Tools Experience: Medidata Rave, InForm, Taimei Technology - EDC, Spotfire, MedDRA, Veeva Vault (eTMF), Basic SAS, Smartsheet, JReview, Advanced MS Excel, MS Project.
SIRI INFOSOLUTIONS INC (TAKEDA). EDISON, NJ, USA
CLINICAL DATA MANAGER – CONTRACTOR, JUL 2024 – FEB 2025
Clinical Data Manager Lead for Phase I/II Hematologic oncology trials.
Designed eCRFs in collaboration with the project team to align with data collection requirements identified in the study protocol, ensuring compliance with CDASH for standardized data collection.
Led the development and implementation of Data Transfer Agreements (DTAs) to standardize the format, frequency, and security of non-CRF data transfers, facilitating seamless collaboration between vendors and internal stakeholders.
Coordinated test data transfers with vendors to validate data quality and adherence to agreed-upon DTA specifications before production transfers.
Conducted rigorous data validation and reconciliation processes to ensure alignment between non-CRF and eCRF data, identifying and resolving inconsistencies to maintain study accuracy.
Facilitated global team meetings to monitor project timelines, review data cleaning progress, and address challenges to ensure study objectives were met.
Oversaw vendor/CRO data management activities to ensure timely execution, adherence to study milestones, and resolution of data-related issues.
Developed and delivered training slides for site personnel, data managers and clinical operations to enhance competency and ensure compliance with data management best practices.
Reviewed project budgets, providing strategic input to ensure cost efficiency, resource allocation.
INSMED, BRIDGEWATER, NJ, USA
CLINICAL DATA MANAGER – CONTRACTOR, NOV 2021 – NOV 2023
Led data management activities as the primary contact for a Phase I/II solid tumor oncology trial, ensuring effective project planning and issue resolution.
Managed data cleaning activities, including oversight of CRO data management activities, conducting ongoing assessments, identifying issues, analyzing data trends, and ensuring timely resolution.
Collaborated with cross-functional teams on post-production change requests to assess impacts and implement database updates.
Created and managed Data Transfer Agreements (DTAs), coordinating with external data vendors to ensure compliance with study timelines and data quality standards.
Led third-party data reconciliation efforts by identifying discrepancies, ensuring alignment with eCRF data, and collaborating with internal teams and vendors to resolve data inconsistencies efficiently.
Established and maintained a vendor issue tracker to monitor and document data discrepancies, track resolution timelines, and ensure accountability in addressing vendor-related challenges.
Programmed non-system edit check, ran SAS programs and reviewed SAS logs, and generated output.
Performed SAE reconciliation, non-CRF data reconciliation, along with reviewing RECIST criteria for tumor assessment to ensure data accuracy and compliance with study protocol.
Participated in the cross-functional review of electronic trial master file (eTMF) to ensure regulatory compliance and completeness.
assist in data cleaning.
Participate in data reviews with clinical team to ensure accuracy, consistency, and reliability of data.
Review discrepancies in EDC system, monitor/facilitate resolution and closeout or re-query per study guidelines; note and communicate trends to clinical operations for follow-up.
Facilitate identification and capture of Protocol Deviations, if applicable
Reconcile external data to clinical study database and perform Serious Adverse Event reconciliation.
Work with study teams to ensure study databases are locked based on pre-defined criteria and established timelines.
Ensure DM procedures and processes are adhered to in a consistent manner.
Provide high quality services through efficient and compliant processes.
Create data review listings for study team using JReview module in the Medidata Rave clinical database.
Upload and QC study documents in Veeva Vault eTMF system for study archival and Quality control
MOORE THAN A SIGNATURE, NC, USA
NOTARY PUBLIC NOV 2015 – NOV 2021
Collaborate with title and mortgage companies as well as third party vendors to meet with borrowers, sellers, and buyers to facilitate loan closing packages. Interact with clientele from diverse sociocultural, educational, and ethnic backgrounds. Describe the functions of document being signed and answer any pertinent questions.
Effective and efficient communication with escrow companies
Build, develop, and nurture relationships with title and mortgage companies, realtors, third Party vendors, and all other industry professional to provide excellent customer service and ensure superior level of member retention.
Specifically trained to facilitate mortgage closing.
Established and maintained consistent contact with buyer, seller, title, and service vender (if contracted) through the completion of the entire signing process.
Conduct quality checks on loan documents to ensure all lender requirement are met.
Comply with privacy laws by properly disposing of non-processed paperwork with personal and financial data.
Coordinate signing appointments with borrowers and return properly signed and notarized documents to lender.
Conduct closing consistent with the legal and ethical standards contained in the laws and rules promulgated by the state in which certified.
Personally observe the signing of documents and verifying the authenticity of each document and/or package.
Return all signed documents to escrow company immediately to ensure that there is no lapse in time to record documents as needed in the various entities involved.
Guarantee that logistics of scheduled staff assignments meet client completion expectation.
Strictly follow lenders closing instructions provided by client.
Promptly deliver all executed documents as instructed by client.
Verify identification of party's signing documents.
EDUCATION
Virginia State University, Petersburg, VA, USA
Bachelor of Science (BS)
LICENSES & CERTIFICATES
Completed Medidata Study Design and Build Essentials (Data Validations for Classic Rave EDC) certification course, September 2012.
Veeva Vault, eTMF Training, October 2020.
JReview Authority, JReview Web Training, October 2020.
Notary/Electronic Notary License – May 2023.
Life/Health Insurance License – May 2024.
Contact this candidate