Senior CDC
About the role
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- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
- 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 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 trainings (including the Study Lead Development program) and courses 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 completed 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.
- Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, 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 investigation or sites for resolution, etc.).
- As required, communicate effectively with the Project team, Study Lead, Project Lead and Project Manager.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, a d/or ability required. Reasonable accommodations may be made to enable individuals with disability to perform the essential functions.
- US/LATAM/CAN: A minimum of 2 year relevant clinical research industry experience.
- EU/APAC: Prior relevant clinical research industry experience.
- Excellent written and oral communication skills.
- Excellent accuracy and attentiveness to detail.
- Capability to work within a team environment.
- Excellent interpersonal skills.
- Knowledge of database technologies and processes.
- Knowledge of regulatory guidelines in relation to data quality and clinical trials conduct.
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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