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Clinical Data Manager Resume Example

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CLINICAL DATA MANAGER
Professional Summary
Detail-oriented Clinical Data Manager currently working at a Oncology R&D Office of a medium sized company interested in clinical data management and research.
Skills

• Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. 

• Working knowledge of Clinical database applications such as EDC and CTMS systems such as Medrio, eCaselink etc.
Work History
Clinical Data ManagerAug 2012 - Jul 2017
Massachusetts General HospitalDanvers


·        Provided Clinical data management support to Clinical Operations team and/or study project, Clinical Data Management team and Biostatistics team. ·             Actively participated in the review of Clinical research documents (e.g. Protocols, Case Report Forms, Reports and Statistical analysis plans). ·             Developed & maintained Data Management Plan (DMP), throughout lifecycle of study project and ensures DMP is followed in accordance with study design and requirements. ·             Develop Case Report Form (CRF), electronic and/or paper.  ·             Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations. ·             Lead EDC database (DB) specification process with external vendors or internal resource as applicable. ·             Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs. ·             Reconcile electronic data transfers from vendor to Sponsor. ·             Develop test scripts and execution logs for User Acceptance Testing (UAT) ·             Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report. ·             Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts. ·             Perform training on study trial for EDC and create user guides. ·             Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock. ·             Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit. ·             Coordinate the archiving of study databases and related documents. ·             Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management databases. ·             Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding. ·             Assist and provide input into study and project level data analysis plan.  ·             Coordinate and communicate with DB vendors on consistent basis to address Clinical team's requests, project plans, and/or eCRF development activities.  ·             Collaborate with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems.  ·             Participates in the preparation and presentation of data, when applicable. ·             Ensures data system compliance by following the established guidelines of national and international regulatory authorities. ·             Participate in conference calls and/or meetings with vendors.   
Education
Master of Public Health: Environmental & Occupational Health2012
College of Health & Human Services, Western Kentucky UniversityCity
BDS: Dentistry2009
Manipal College of Dental SciencesCity, State
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Resume Overview

School Attended

  • College of Health & Human Services, Western Kentucky University
  • Manipal College of Dental Sciences

Job Titles Held:

  • Clinical Data Manager

Degrees

  • Master of Public Health : Environmental & Occupational Health 2012
    BDS : Dentistry 2009

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