As a CDC II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• 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. May include the following:
• Acts as liaison between sponsor, CRO and eCOA vendor/external data vendor.
• Ensures accessibility of eCOA/external data to all relevant sponsor and CRO team.
•  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 sponsor and CRO team.
• 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.
• eCOA/ePRO experience.

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
  inspection

Data Collection Systems

• 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
  Additional Activities

You are:

•  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.

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.