Senior CDC

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
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

Requirement:

• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
• Minimum 6 Years of experience in core DM activities
• Query management, Data cleaning activities , Data reconciliations, SAE reconciliations, Conduct activities & Close out activities.
• Strong EDC background, Rave or Veeva EDC preferred.
• 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 stakeholders.
• Excellent problem-solving skills
• Excellent verbal and written skills
• Only Chennai Location - Officebased [Hybrid]

Technical/Communications Skills:

• Through knowledge of end-to-end clinical trial data transfer process
• In-depth knowledge of data management systems and processes
• Excellent teamwork, organizational, interpersonal, and problem-solving skills
• Work effectively with global team in a diverse environment

• 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