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Emmess Services

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16 Emmess Services Jobs

Sr Clinical Data Manager

Emmes

6-10 years

Bangalore / Bengaluru

1 vacancy

Emmess Services

posted 4mon ago

Job Role Insights

Key skills for the job

Clinical Research Clinical Data Management Medical Records Data Collection Troubleshooting EDC

+ 2 more

Job Description

Collaborates with cross-functional teams and facilitates the design, documentation, testing and implementation of clinical data collection studies in an electronic data capture (EDC) system Creates and/or
reviews study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards
Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner
Determines data collection requirements based on the study protocol and system knowledge, makes recommendations based on previous experience
Proactively identifies potential data management issues/risks and recommends/implements solutions
Manages data collection and data validation at participating clinical sites
Manages training documentation and provides oversight of system user access, may serve as resource for troubleshooting system issues
Creates and/or reviews study data management documents (eData Management Handbook, Data Management Plan, Data Validation Plan, EDC System User s Guide, EDC Training and Certification Documents)
Independently monitors own activities and project status for successful project deliverables according to timelines
Manages data reports and creates data summaries or presentations as applicable
Manages the development of the data validation plan and ensures associated edit checks are completed in accordance with project timelines
Manages and reconciles data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources
Performs data review and query identification/resolution, manages data quality metrics for a protocol or project
Attends and contributes to project and functional group meetings, may serve as DM representative on external calls as required
Mentors staff on project-specific clinical data management processes, provides data management expertise at a project level May provide direct line support for DM staff