As a CDC II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Location : Bangalore, India [Office-based]
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, Study Specific Procedures (SSPs), International Committee on Harmonization (ICH) Guidelines, and all applicable laws and regulations.
• 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
• 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
• 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
- Bachelor's Level Degree
- Clinical Development
- Clinical Trials Data Management
- Act as a mentor to junior staff level
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
