Clinical Data Manager resume example with 4+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
H: (555) 432-1000
C:
resumesample@example.com
Date of Birth:
India:
:
single:
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 Manager, 07/2012 - 06/2017 Massachusetts General Hospital – Danvers, ,
·
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 Health, Expected in 2012 - College of Health & Human Services, Western Kentucky University - Bowling Green Kentucky, GPA:
BDS: Dentistry, Expected in 2009 - Manipal College of Dental Sciences - Mangalore, Karnataka, INDIA GPA:
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Resume Overview
School Attended
College of Health & Human Services, Western Kentucky University