1) Prepare data analysis listings and activity, performance, or progress reports.2) Process clinical data including receipt, entry, verification, or filing of information.3) Prepare appropriate formatting to datasets as requested.4) Design and validate clinical databases including designing or testing logic checks.5) Design forms for receiving, processing, or tracking data.6) Develop or select specific software programs for various research scenarios

CRF/eCRF Design Data Entry Database Design and Build (Paper and EDC) Data Check Design and Build (Paper and EDC) Data Query management Data Validation/Cleaning Medical Coding (MedDRA, WHO Drug) Data Management Documentation Quality Control all through the priocess and Database Lock

• Provide Clinical data management support to Clinical Operations teamand/or study project, Clinical Data Management team and Biostatisticsteam.• Participates in the review of Clinical research documents (eg. Protocols,Case Report Forms, Reports and Statistical analysis).• Develops Data Management Plan (DMP), maintains DMP throughoutlifecycle of study project and ensures DMP is followed according to studydesign and requirements.• Develop Case Report Form (CRF), electronic and/or paper.• Develop database (DB) clinical trial data specifications, including eCRFdesign, user requirements, edit rules/checks, query logic and datavalidations.• Lead EDC database (DB) specification process• Develops Data Transfer Agreement(s) (DTAs) between external datavendors and/or core labs.• Reconcile electronic data transfers from vendor to Sponsor.• Coordination of UAT of eCRF build and validation documents, included butnot limited to: edit check document, issue logs, UAT summary report.• Maintenance/tracking of EDC user management and other Clinicaldatabases 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 andfreeze/unfreeze as appropriate for statistical review, interim review, and orfinal database lock- included but not limited to: data reconciliation and/or coding.• Assist and provide input into study and project level data analysis plan.• Coordinate and communicate with DB vendors on consistent basis toaddress Clinical teams requests, project plans, and/or eCRF developmentactivites.• Collaborate with IT and implementation team(s) to address Clinicalapplication requests and/or changes to Clinical database systems.• Ensures data system compliance by following the established guidelines ofnational and international regulatory authorities.