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 ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post : Senior CDC
In accordance with project specific timelines, to perform data management activities to ensure the generation of accurate, complete, and consistent clinical databases. To assist with the training of less experienced Clinical Data Coordinators. To fulfill his / her job responsibilities in accordance with Good Clinical Practices (GCPs), ICON Standard Operating Procedures (SOPs), Working Procedures (WPs),Study Specific Procedures (SSPs), International Committee on Harmonization (ICH) Guidelines, and all applicable laws and regulations..
- Complete all assigned trainings (including the Study Lead Development program) and co rses in the ICON Training Management system (iLearn); 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. PlanviewTM).
- Review CRF / eCRF data for completeness, accuracy, and consistency via computerized edits and manual data checks.
- Perform external data reconciliation.
- Perform Serious Adverse Event reconciliation.
- 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.
- Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures.
- Train and guide less experienced CDCs in data management requirements and activities
- 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.).
• A minimum of 6 year relevant clinical research industry experience.
• Prior relevant clinical research industry experience.
• Excellent written and oral communication skills.
• Excellent accuracy and attentiveness to detail.
• Capability to work within a team environment.
• Academic or Trade qualifications: Any graduate
Experience : 6 years
Qualification : Lifescience graduate
Location : Trivandrum
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : CDC
End Date : 15th September, 2018
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