Senior Clinical Data Manager with 20 Years Experience

Ronald Smith

******@*******.*** 215-***-**** Prospect Park, PA 19076

SUMMARY

Excellent organizational, administrative and time management skills. Very analytical and thorough. Able to work effectively as part of a team or individually. I would like to obtain a position in an organization with potential for growth and advancement, using my skills, training, work background and experience of 20 years in Clinical Data Management for Phases 1 – 3 studies, start-up, maintenance, and close out activities

THERAPEUTIC AREAS:

Oncology – Head and Squamous Cell, Breast, Prostate, Colorectal Cancer, Central Nervous System – Alzheimer’s disease, Cardiovascular – Deep Vein Thrombosis (blood clotting), Heart Disease, Women’s Health – Contraception, Rare Diseases, HIV – Vaccines

EDUCATION

University of Phoenix, MIS in Information Systems

University of Phoenix, BSIT degree in Information Technology Anthem Institute, Certificate in Computer Programming WORK EXPERIENCE

Clinical Data Manager II – Fortrea – Durham, North Carolina - July 2021 – April 2024

• On a study team of 10, was 1 of 2 data managers selected to provide startup and close out activities for studies resulting in a faster turnaround to bring study drug to market

• Creation of study start up clinical trial documentation including Data Management Plans and/or Data Review Guidelines and raise queries to resolve mistaken, missing, incomplete data

• Demonstrated capability to read and follow study timelines for on-time deliverables and potential to help with inputs on study design.

• Ran and executed other programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data

• Generate, resolve, and track queries to address problematic data found during aggregate data review activities

• Interacted with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as needed

• Reviewed Edit Check Specifications and Database specifications

• Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as needed

Clinical Data Manager – Prevail InfoWorks – Philadelphia, PA - March 2020 - June 2021

• Served as the contact for Data Management related issues and concerns for studies and daily management of study timelines and deadlines resulting in successful trial completion

• Defined eCRF specifications from study protocols

• Defined, built, and performed UAT of dataset specifications, eCRF forms, edit checks, and validation specifications

• Wrote and executed Data Management Plans, Manual Review Guidelines, Data Coding guidelines, Data Transfer Guidelines and other documentation as needed per study

Clinical Data Manager – ERT – Philadelphia, PA - June 2016 -February 2020

• Served as the primary internal and Sponsor contact for Data Management questions, issues or concerns including, but not limited to-Data delivery, Data reconciliation including query resolution, Data Management activity timelines.

• Created the Data Management Plan (DMP) and Data Transfer Specifications (DTS) in collaboration with Sponsors to define study requirements

• Determined standard edit checks necessary to ensure clean data and define new edit checks when standard checks are insufficient

• Collaborated with internal teams on study setup requirements such as demographic collection and visit schedule requirements

• Communicated contents and commitments in the DMP to the internal CDM teams

• Completed data management related pages in EXPERT (Cardiac or Pulmonary only.)

• Lead the development, review, and finalization of Data Transfer Specification (DTS) or Load Specifications (LS) and/or Edit Check Configuration documents (EC). Provide or customize ERT standard file specifications, review and/or consult with Sponsor on Sponsor-defined specifications and coordinate finalization and approval of file specifications between Sponsors and System Analysts.

CONTRACT POSITIONS

Clinical Data Coordinator (contractor) – Covance, Inc – Conshohocken, PA September 2015 – March 2016

• Serve as a member of the project team with primary responsibility for clinical data review, query generation / resolution and reconciliation activities to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets

Clinical Data Management/Lab Data Coordinator (contractor) – Merck - April 2015 – September 2015

• Using Inform database, reports, and/or listings, did daily review of all labs for oncology study

• Queried all out-of-range values for all labs as needed

• Aided in protocol deviation review, study medication review and other assignments as needed

• Handled competing priorities/activities and simple to moderately complex problems related to medical monitoring and data cleaning

• Communicated status updates and various discrepancies to project team in team meetings Clinical Data Manager (contractor) – UBC - Blue Bell, PA - February 2014 – April 2015

• Served as UBC primary contact for data on a project

• Design or help in designing databases to meet study needs including UAT of test scripts

• Provide input into Edit Specifications and coordinate development and validation of study database

• Review and provide input to ensure DCTs meet data needs prior to going into production. COMPUTER SKILLS - IBM utilities, SAS, SQL, PL/SQL, HTML, DHTML, Visual Basic, C, C++, Java/JavaScript, Windows OS, Microsoft Office applications, Microsoft Project, Visio, FrontPage, Clintrial, Oracle Clinical,JReview,WebSysEDC Data Management System, AMOS, Medidata Rave, InForm, Medrio, Sapphire SAE system, UBC Capture, EXPert database system MILITARY - United States Navy RM3 – Various locations May 1985 - May 1991

Contact this candidate