Clinical Data Manager
Resume:
Curriculum Vitae
Edwina W. Williams
Page *
Edwina W. Williams
Waxahachie, TX 75165
*****************@*****.***
PROFESSIONAL EXPERIENCE:
Fortrea, Inc. (Formerly LabCorp / Covance Inc., Dallas, Texas February 2021 – Present
Clinical Data Manager ll
July 2022- Present
• Accountable for database review, testing and UAT of edit checks for assigned studies.
• Build and maintain good DM relationships across internal functional units and sponsors.
• Attend and action client or internal audits as appropriate and resolve all issues within an appropriate time. Address client comments with the study team.
• Coordinated, created, and maintained the Data Management Plan, eCRF Completion Guidelines and training materials.
• Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved.
• Generated, resolved, and tracked queries to address problematic data identified during data review activities.
Associate Clinical Data Manager
November 2021 – July 2022
• Ensured filing of study specific documentation as required by SOPs and study needs.
• Acted as a resource to CDM team for questions and guidance as related to clinical data.
• Provided reports to Sponsor and internal team as dictated by project need.
• Possess knowledge of all company procedural documents that impact DM.
• Attended internal and external project meetings providing input from a CDM perspective. Ensured assigned actions are completed within the required timeframe.
• Maintained all data management study documents in the designated Trial Share area and PMF as required.
• Assist in the review of the database design and annotate the CRF (eCRF) according to the specifications.
Senior External Data Specialist
February 2021 - November 2021
• Ensured proper training was assigned, completed and training records were up to date for direct reports.
• Thorough understanding of Clinical Data Management tasks and assigned protocol(s) with ability to critically evaluate the information in relation to other key project documents and processes.
• Monitored tasks vs. contractual obligations for CDM and reported any out-of-scope items to the Project Data Manager. Provided oversight to external suppliers such as EDC vendors. Curriculum Vitae
Edwina W. Williams
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• Performed review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that required further investigation.
• Generated, resolved, and tracked queries to address problematic data identified during data review activities.
Healthy Lifestyles For tru Friends, DeSoto, Texas
September 2009 - December 2019
Regional Site Monitor
• Served as site monitor for all assigned Texas Department of Agriculture (TDA) Food and Nutrition
(F&N) Division approved sites ensuring that TDA nutritional requirements were met and delivered on time and to high quality.
• Provided consolidated comments from the site on the draft protocol to the Program Director, considering operational and subjects Food and Nutrition issues.
• Distributed protocols and amendments to the site staff.
• Performed data review and query generation.
MedFocus LLC. Alcon Laboratories, Fort Worth, Texas January 2008 - September 2009
Data Manager
• Made Corrections to clinical database and reports.
• Worked directly with study lead and assisted in the closure and locking of several studies performed QC checks: first and second pass.
• Performed edit check review for CRF’s and DCF’s within Clin-trial and I-Review for data validations.
• Identified errors and inconsistencies in CRF data and followed up as necessary to ensure proper resolution.
• Appropriately freeze and locked data for statistical and blinded interim quality reviews and the interim and final database lock.
US Oncology, Dallas, Texas
October 2001 - January 2008
Project Data Manager
• Served as liaison between clinical trial sponsors and clinical sites.
• Daily interacted with monitors, nurses, and physicians to ensure patients were receiving proper treatments and adhering to scheduled follow ups as specified in protocol.
• Conducted regular reviews of CRF, RAP, database specification and guideline documents and followed up on any issues, appropriately archived study documentation post-database lock.
• Developed and maintained computerized/manual CRF of patients with experience in opening and closing clinical trials.
• Managed both clinical and CRO-led internal studies, and was responsible for study set up, ongoing maintenance and any necessary database locking. Curriculum Vitae
Edwina W. Williams
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THERAPEUTIC EXPERIENCE:
• Immune Mediated Inflammatory Disease (IMID): Inflammatory Bowel - Crohn’s Disease
(Phase lll), Ulcerative Colitis (Phase lll)
• Infectious Diseases: Antiviral Therapy – Hepatitis B Viru (All Phase), HIV (All Phase)
• Oncology: Solid Tumors - Multiple Solid Tumors (Phase I), Breast Cancer (Phase lll), Lung Cancer (Phase ll and lll)
• Ophthalmology: Front of Eye Disorders Cataract (Phase ll and lll), Front of Eye Disorders Glaucoma (All Phase), Back of Eye Disorders Retinal Disorders – Other (All Phase) SYSTEM EXPERIENCE:
• Dart, 3 years
• Medidata Rave, 3 years
• JMP, 9 months
• Veeva Vault, 3 years
• CTMS, 8 Years
• Oracle, 6 years
• Clin-trial, 2 years
• I-Review, 2 years
EDUCATION / CERTIFICATION:
• Standford Brown College, Dallas, Texas, Registered Medical Assistant (RMA), 2000
• Star X-Ray, Hurst, Texas, Radiologic Tech Certification, 2003
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