In accordance with project specific timelines and data review plans, perform data management activities to ensure the generation of accurate, complete, and consistent clinical databases.
To fulfil his/her job responsibilities in accordance with Good Clinical Practices (GCPs), ICON Standard
Operating Procedures (SOPs), Working Procedures (WPs), Study Specific Procedures (SSPs), Sponsor SOPs/WPs as appropriate, International Committee on Harmonization (ICH) Guidelines, and all applicable law and regulations.
What you will be doing:
- Recognize, exemplify and adhere to ICON's values which centre on our commitment to People,
Clients and Performance. - As a member of staff, the employee is expected to recognize the importance of and create a 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 (or sponsor as appropriate).
- 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 and courses in the ICON Training Management system (and / or sponsor system, as appropriate); ensuring all mandatory courses are 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.
- Assist Data Management Study Lead in development of the Data Management Plan (DMP) and Data Validation Plan (DVP) for assigned trials which include taking an active part in any review meetings.
- Provide input to writing specifications for study specific validation checks and necessary reports to ensure high quality and consistent data.
- Assist in the preparation of training materials for investigator meetings.
- Perform DM activities for start-up of a study including assisting in preparing the eCRF, CCGs, DMPs, DVPs and performing User Acceptance Testing (UAT) if required.
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 clinical trial database technologies and processes.
Knowledge of regulatory guidelines in relation to data quality and clinical trials conduct.
3 + years Clinical Data Management experience in Data Validation, Reconciliation and Cleaning.
Immediate Joiners Preferred
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.
