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:

* Performs data review of clinical trial data, including query management.
* Performs detailed review of eCOA/external data per the Date Review Plan and works closely with the vendor and CRO to resolve eCOA/external data related issues.
• Acts as liaison between CRO and eCOA vendor/external data vendor.
• Ensures accessibility of eCOA/external data to all relevant teams.
• QCs a sample of data clarification requests processed by the eCOA/external data vendor.
• Maintains eCOA/external data issues within the centralized study data issues log.
• Ensures appropriate and timely communication of eCOA/external data related issues and resolutions to relevant teams.
* Performs reconciliation review of eCOA/external data against EDC data and works with applicable parties to resolve queries. 
* Performs SAE (Serious Adverse Event) reconciliation and communicates with applicable safety team 
members to resolve issues.
* May prepare and distribute performance metrics (e.g. site completion of data entry and resolution of  queries) to applicable stakeholders. Escalates to CDM Lead and study team as needed.
* Contributes to the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.
* Performs additional review activities for interim and final database locks as needed.
* Files study documentation in electronic Trial Master File (eTMF) and department project files.
* Performs periodic quality review of eTMF documents.
* Assists with taking meeting minutes and documenting/tracking study data management activities.
* Performs data archival activities.
* Performs inspection readiness activities and supports CDM team during internal and regulatory inspections.
* Supports the set-up and testing of study data collection tools such as EDC (electronic data capture), IRT (interactive response technology), eCOA (electronic clinical outcome assessment), ePRO (electronic patient reported outcomes), and creation/maintenance of associated documentation.
* May contribute to the creation and maintenance of study eCRF Completion Guidelines and other data collection tool guidelines.
* May assist with management of account access and training materials for data collection tools.
* Mentors other data coordinators

Your Profile:

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

*Bachelor's degree in a relevant field, such as Life Sciences or Healthcare.

* Understanding of clinical trial documents (protocols, case report forms, data management plans, study reports) and processes
* Preferred 2-5 years relevant work experience, or equivalent combination of training and experience.
* Preferred experience in data management/drug development within GCP/clinical research regulatory 
environment.
* Experience with electronic data collection systems.
* Experience managing multiple work deliverables and deadlines.
* Knowledge of data management best practices & technologies as applied to clinical trials.
* Knowledge of FDA and ICH regulations and industry standards applicable to data capture and data 
management process.
* Strong attention to detail, and organizational skills
* Good time management skills
* Quick learner and comfortable learning new technologies and systems
* Advanced knowledge of office software (Microsoft Office).
* Demonstrated good communication and project management skills

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What ICON can offer you:

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.

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