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.
Post: CDC II
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:
• 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.
• Working closely with the DM trial partners and provide support as required to additional Data Management activities.
• Follow the Data Management Monitoring (DMM) and Risk Assessment Categorisation Tool (RACT) on a trial.
• Planning, coordinating, and assessing the associated risks of data review using various tools and technologies.
• Support the creation and execution of data review related reports and data review strategy.
• Maintaining an overview of the data review status and communicating relevant information to the DM Trial Partners.
• Maintaining an overview of the data review status and communicating relevant information to the DM Trial Partners.
• Collaborating with relevant Trial Partners and other stakeholders to successfully achieve the data review deliverables on the trial.
• The CDIA may assume the Clinical Trial Data Manager (CTDM) role for the clinical trial(s).
Effectively communicate data findings including visualizations with clear explanations.
• Proactively own and independently drive all data review under experienced CDR purview, taking complete ownership and responsibility.
• Use data visualisation methods to review and understand data to support trial partners in making operational decisions.
• Maintain CDR relevant trial documentation and ensure applicable archival on an ongoing basis.
• Resolves or escalates issues identified during the review and update to DM trial partners.
• Prepare and participate in audits and inspections.
• 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.
Location: Bangalore
Clinical Data Management
ICON Strategic Solutions (FSP)
Hybrid
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