Clinical Data Management

ANTHONY BASICH

Clinical Data Manager

Telephone: 917-***-****

*******@*****.***

PROFESSIONAL EXPERIENCE

Freelance Consulting, Maywood, NJ 2024 – present

Writer & Editor

●Provides copy for clients’ promotional websites and blogs

●Edits and proofreads copy for online content

Medpace, Cincinnati, OH 2022 – 2024

Data Manager 2022 – 2024

●Manages the Electronic Data Capture database for clinical trials from startup through study conduct to database lock

●Supervises data coordinators to complete data cleaning tasks

●Coordinates with third-party vendors to draft data transfer agreements and manage external lab data

●Creates and maintains Case Report Forms, Edit Check Specifications and Data Management Plan

●Faces with clients in routine meetings to provide reports for the ongoing progress with a study’s data management

●Generates, issues, tracks and responds to data queries to resolve all data discrepancies in a timely manner

●Develops and delivers presentations for investigator meetings and bid defense conferences

IQVIA Biotech/TKL Research, Rochelle Park, NJ 2007 – 2022

Clinical Data Manager 2013 – 2022

●Manages the Electronic Data Capture database for clinical trials from startup through study conduct to database lock

●Codes medical terms for the database safety datasets from the newest versions of medical dictionaries, MedDRA and WHO Drug.

●Oversees projects, ensures timely completion of tasks and trains Clinical Data Coordinators

●Creates and maintains Case Report Form, Data Management Plan and Data Management Database

●Tracks, files and archives case report forms and other source data when delivered to Data Management for data entry

●Reviews clinical data via data listings and programmed edit checks

Clinical Data Coordinator 2008 – 2013

●Oversees projects, ensures timely completion of tasks and trains Associate Clinical Data Coordinators

●Supervised Data Management support staff by delegating and prioritizing data entry work in support of the data managers

●Tracks, files and archives case report forms and other source data when delivered to Data Management for data entry

●Reviews clinical data via data listings and programmed edit checks

●Generates, issues, tracks and responds to data queries to resolve all data discrepancies in a timely manner

●Coordinates the essential tasks in order to successfully meet the strict deadline of database lock

●Manages the ClinPlus Data Management System in support of the department by troubleshooting technical problems and resolving them

●Writes and develops the process documents detailing and describing all tasks involved in the data management position

Associate Clinical Data Coordinator 2007 – 2008

●Supported Clinical Data Coordinator with various Data Management (DM) activities

●Created and maintained Case Report Form, DM Plan and DM Database

●Tracked, filed and archived case report forms and other source data when delivered to DM for data entry

●Reviewed clinical data via data listings and programmed edit checks

●Generated, issued, tracked and responded to data queries to resolve all data discrepancies in a timely manner

EDUCATION

MS in Journalism 2006

Columbia University, New York, NY

BA in English Literature 1997

Hofstra University, Hempstead, NY

SKILLS

Proficient in Electronic Data Capture (EDC) systems: Medidata Rave, ClinPlus, DSG & ClinTrak

SAS data software

Structured Query Language (SQL)

Medical Coding: MedDRA & WHO Drug dictionaries

Proficient in Microsoft Office: Word, PowerPoint, Excel and Outlook

Strong written and communication skills

Organizational skills and time management

THERAPEUTIC AREAS

Dermatology (Including Skin Cancer)

Respiratory

Cardiovascular

Ophthalmology

Endocrinology

Medical Devices

Gastroenterology

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