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DEPARTMENT: Data Management
JOB TITLE: Clinical Data Coordinator III
REPORTS TO: Data Management Project Lead, Data Management Project Manager

SECTION 1: POSITION SUMMARY

In accordance with project specific timelines, to perform data management activities to ensure the
generation of accurate, complete, and consistent clinical databases. To assist with the training of less
experienced Clinical Data Coordinators. To fulfill hisfher job responsibilities in accordance with Good
Clinical Practices (GCPs), ICON Standard Operating Procedures (SOPs), Working Procedures (WPs),
Study Specific Procedures (SSPs), International Committee on Harmonization (ICH) Guidelines, and all applicable laws and regulations.

SECTION 2: JOB FUNCTIONSIRESPONSIBILITIES

• "'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
• Travel (approximately 0%) domestic andlor 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 training (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 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 andlor 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
• •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 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.

SUPERVISION

Act as mentor to junior level staff

SECTION 3: EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS

• 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, and/or ability
required. Reasonable accommodations may be made to enable individuals with disabilities 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
• Ability 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

SECTION 4: EDUCATION REQUIREMENTS

• Bachelor's degree or local equivalent in a scientific discipline andlor appropriate experience

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

What’s Next

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

Impactful work. Meaningful careers. Quality rewards.

At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential.
Learn more about Our Culture at ICON

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