CDC II

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:

Supports and executes the data review activities, including data validation and analytics, that contribute to delivery of clinical data that meets agreed upon data integrity standards.

• Supports activities related to development of the clinical data management systems (CDMS), as needed.
• Supports and executes the data review activities, including data validation and analytics, associated with a clinical trial to ensure the end product of clinical data meets agreed upon data integrity standard
• Detects risks and signals in the data using quality indicators.
• Performs root cause analysis of detected data issues.
• Data entry services, including specifically entry of safety and efficacy data from and relating to investigator initiated trials (“IIT Data”) using Company’s GvHD product (“Product”) into Company’s Medidata EDC System
• Data Management services as requested from time to time by Company
• Review and evaluation of IIT data as needed and requested for purpose of assisting Company in preparation of submission documentation and an ISS for is biologics licensing application
• Serves as lead clinical data coordinator for one or more projects
• Reviews clinical and external data for subjects enrolled in clinical research protocols based on edit specification/data validation programs to facilitate data review
• Maintains data management study documentation as appropriate
• Performs proficient reviews of study datasets prior to client transfer
• Manages the data review and external data reconciliation process
• May participate in sponsor and/or third party audits in connection with services

You are:

• BA Degree in relevant field of study, or an equivalent combination of education, training, and relevant experience
• 1-3 years of relevant experience
• Must read, write and speak fluent English and host country language
• Ability to work collaboratively and effectively in a cross-functional and culturally diverse team
• Basic knowledge of the drug development process including risk based monitoring
• Working knowledge and understanding of clinical data management systems or electronic data capture software
• Basic skills in aggregate data review and interpretation using visualization/analysis software e.g., JReview, Tableau, SAS
• Solid written and communication skills
• Strong skilled in utilization of computerized information systems and standard application software, e.g., Windows, MS Office

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

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.