Clinical Data Co-ordinator

6 months ago

Johannesburg, South Africa ICON Full time

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

As a Clinical Data Coordinator at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified Clinical Data Managers to identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

Key requirements for this role are:

- As a member of staff, the employee is expected to recognize the importance of and create 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 I or international.
- Read, ensure understanding and adhere to all assigned ICON SOPs and working pr cedures.
- Ensure all work performed is of high quality, compliant with Good Clinical Practice, 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 co pleted for current studies.
- Record all billable and non-billable time in the appropriate timesheet management s stem (e.g. Planview).
- Review CRF I eCRF data for completeness, accuracy, and consistency via computerize 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 i ues found through re-testing and resolution.
- Assist Data Management Study Lead in development of eCRF, Data Validation Specific tions, 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 a e met (for example, filing and archiving of study documentation, dispatching of queries to investiga or sites for resolution, etc.).
- As required, communicate effectively with the Project team, Study Lead, Project Lead nd Project Manager.

What you need:
Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 5 + years of experience in core Clinical Data Management.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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