CDC II

CDC II

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a CDC II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

Your role will involve delivering clinical data management work to a high standard, working closely with your team and stakeholders.

Key responsibilities include:

• Planning, coordination, and associated risk assessment of data review, via different tools and technologies.  
• Defines the data review requirements for the trial with input to and from the RACT, in collaboration with the required Trial Partners. 
• Collaborate with the relevant programmers to ensure setup of the data review tools. 
• Maintains overview of the data review status and communicates relevant information to the CTDM. 
• Collaborate with the relevant Trial Partners and other stakeholders to successfully achieve the data review deliverables on the trial
• Participation in process and toolkit improvement projects as required to support data review process evolution.
• Driving risk-based data management approaches to data review
• Data and issue trending relating to data quality and integrity and reporting of such to PoC.
• Liaising with process specialists on process changes and improvements
• Ensure that clinical data meets applicable regulatory requirements, quality, and data standards, and is reviewed and cleaned as per trial timelines.
• Ensure that DM-related activities comply with all applicable internal and external requirements.
• Provides input to Risk Assessment Categorization tool (RACT)
• Maintain a strong working relationship with the relevant DM trial partners.
• Review clinical data in various database formats, datasets, listings, reports, visualizations, and analytics for completeness, accuracy, and integrity.
• Raise, review and close of queries with EDC/CDMS ensuring that data is reviewed and corrected as required by qualified site staff.
• Create DMM, write specs for DMM and any other review plans as needed for the trial.
• Review large datasets from various sources for accuracy, completeness, and consistency.
• Identify and rectify errors or inconsistencies in data following established protocols.
• Develop and implement data review checks and procedures to maintain data integrity.
• Contribute to creation and maintenance of various dashboards.
• Effectively communicate data findings including visualizations with clear explanations.
• Use data visualisation methods to review / understand data to support trial partners making operational decisions.
• Maintain CDR-relevant trial documentation and ensure applicable archival on an ongoing basis.
• Resolve or escalate issues identified during the review and update to DM trial partners.
• Prepare for and participate in audits and inspections

The CDIA may assume the Clinical Trial Data Manager (CTDM) role for the clinical trial(s).

• Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures.
• Manage clinical and third-party data reconciliation based on edit specifications and data review plans.
• Tracks and communicates status of study and task metrics to clinical data scientist, project team, and functional management.
• Address data related questions and recommend potential solutions.
• Identify root cause to systematically resolve data issues.

Your Profile:

You will bring relevant clinical data management experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in a relevant field, such as Life Sciences or Healthcare.
• Intermediate knowledge of clinical data management within the pharmaceutical or biotechnology industry.
• Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar).
• Strong attention to detail and the ability to work effectively in a fast-paced environment.
• Excellent communication skills and the ability to collaborate with cross-functional teams.
• Knowledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus.

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

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply