CDC I
Overview
As a Clinical Data Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing: Data Review
- Performs data review of clinical trial data, including query management
- Performs reconciliation review of external data against EDC data
- May assist in creating study documents or assist in running study reports and metrics
- Performs additional review activities for interim and final database locks as needed.
Documentation & Filing
- 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 Data Collection Systems
- May support the set-up and testing of study data collection tools.
Additional Activities
- Assists with quality review of above activities performed by the CRO, as needed.
- Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
- Performs other duties as assigned.
Qualifications
You are: Educational Qualifications
- Associate or Bachelor's Degree preferred
Experience
- Ideally 1 or more years relevant work experience, or equivalent combination of training and
experience.
- Familiar with electronic data collection systems
- Preferred knowledge of data management best practices & technologies as applied to clinical
trials.
- Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture
and data management process. 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 maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits 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, colour, 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 through the form below. https://careers.iconplc.com/reasonable-accommodations 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. Apply Job! Apply to this Job