Senior CDC

This job is with ICON plc, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

As a Senior CDC you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Location : Chennai [Officebased - Hybrid]

Immediate Joiners Only !

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

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

Visit our careers website to read more about the benefits of working at ICON : https : / / careers.iconplc.com / benefits

At ICON, inclusion & belonging are fundamental to our culture and values. 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.

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.

Skills Required

User Acceptance Testing, Data Cleaning, data reconciliation