Clinical Data Coordinator

Summary:

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.

Responsibilities:

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.

Review CRF / eCRF data for completeness, accuracy, and consistency via computerized edits and

manual data checks.

Generate and close/resolve (as appropriate) data queries.

Identify errors and inconsistencies and resolve them or initiate the resolution as specified in the DVP during the clinical trial conduct.

Assist in the determination of listings to be used during the data validation process.

Generate listings to the study team and review of listings for data quality.

Perform 3rd Party reconciliation activities in a timely manner and according to SOPs and WPs.

Perform Serious Adverse Event (SAE) reconciliation activities in a timely manner and according to

SOPs and WPs.

Maintain effective working relationship with vendors and other stakeholders as required.

Identify possible trends in data.

Participate in the preparation of final study documentation.

Participate in the activities necessary for database finalization adhering to the timelines established by the study team.

Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System.

Create and maintain study files and other appropriate study documentation.

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.).

Communicate effectively with the project team, Study Lead, Project Lead and Project Manager.

Attend study team meetings as necessary.

Prepare training materials for data management activities and processes as required