• 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.|
Clinical data management support to Clinical Operations team and/or study
project, Clinical Data Management team and Biostatistics team.
participated in the review of Clinical research documents (e.g. Protocols, Case
Report Forms, Reports and Statistical analysis plans).
maintained Data Management Plan (DMP), throughout lifecycle of study project
and ensures DMP is followed in accordance with study design and requirements.
Report Form (CRF), electronic and/or paper.
(DB) clinical trial data specifications, including eCRF design, user
requirements, edit rules/checks, query logic and data validations.
database (DB) specification process with external vendors or internal resource
Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
electronic data transfers from vendor to Sponsor.
scripts and execution logs for User Acceptance Testing (UAT)
UAT of eCRF build and validation documents, included but not limited to: edit
check document, issue logs, UAT summary report.
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.
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.
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.
archiving of study databases and related documents.
close-out audit, as specified, for closing of study trial in EDC or other
clinical data management databases.
reconciling AE/SAE data in Safety DB and/or other Data Management DB, including
but not limited to, performing MedDRA and/or WHO coding.
provide input into study and project level data analysis plan.
communicate with DB vendors on consistent basis to address Clinical team's
requests, project plans, and/or eCRF development activities.
IT and implementation team(s) to address Clinical application requests and/or
changes to Clinical database systems.
the preparation and presentation of data, when applicable.
system compliance by following the established guidelines of national and international
conference calls and/or meetings with vendors.
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