CDC II
- Bangalore
- ICON Strategic Solutions
- Biometrics Portfolio
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
As a CDC II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
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 ProceduresryJPs), 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
- University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
- CDC II who are in the role from or before 2021
- Ability to work under pressure demonstrating agility through effective and innovative team leadership
- Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders
- Excellent problem-solving skills
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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