CDC II

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.

We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.

Title: CDC II, Early phase

Job Location: Chennai

Job Description Summary

Under minimum supervision of more experienced Data Management Personnel and in accordance with project specific timelines, to perform basic data management activities to ensure the generation of accurate, complete, and consistent clinical databases. To fulfill his/her job responsibilities in accordance with Good Clinical Practices (GCPs), ICON Standard Operating Procedures (SOPs), Working Procedures ryJPs), Study Specific Procedures (SSPs), International Committee on Harmonization (ICH) Guidelines, and all applicable laws and reQulations.

Job Description

• *Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance

• *As a member of staff, the employee is expected to embrace and contribute to our culture of process

Improvement with a focus on streamlining our processes adding value to our business and meeting client needs

• Travel (approximately 0%) domestic and/or international

• *Read, ensure understanding and adhere to all assigned ICON SOPs and working procedures

• *Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations

• *Complete all assigned training (including the Study Lead Development Program) and courses in the ICON Training Management system (i earn); ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies

• *Record all billable and non-billable time in the appropriate timesheet management system (e.g. Planview™)

• *Review CRF/eCRF data for completeness, accuracy, and consistency via computerized edits and manual data checks

• *Generate and close/resolve (as appropriate) data queries

• *Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System

• *Create and maintain study files and other appropriate study documentation

• *Perform User Acceptance Testing and collaboratively work with CDMS personnel to see issues found through re-testing and resolution

• *Perform other project activities as required in order to ensure that study timelines are met (for example, filing and archiving of study documentation, dispatching of queries to investigator sites for resolution, etc.)

• *As required, communicate effectively with the project team, Study Lead, Project Lead and Project Manager