Employer: PRA Health Sciences
Overview
- ICON plc is a world-leading healthcare intelligence and clinical research organisation.
- From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
- With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
- Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
- 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 standards.
- Detects risks and signals in the data using quality indicators.
- Performs root cause analysis of detected data issues
- Performs duties at a high standard of quality under general supervision.
- Reviews clinical and third party data for subjects enrolled in clinical research protocols based on edit specifications/Integrated data review plan to facilitate data review.
- Maintains clinical data management related study documentation as appropriate.
- Manages third party data reconciliation and data review process Trains other team members in clinical data management skills and processes for individual studies.
- Utilizes internal systems to optimize and communicate resourcing issues and needs.
- Ensures study and task metrics are tracked and communicated to the clinical data scientist, project team and functional management.
- Addresses data related questions and recommends potential solutions; escalates issues that potentially impact study analysis.
- Documents data issues within system of record for communication of issues with owners.
- Identifies root cause to systematically resolve data issues.
- Responsible for review of standard quality indicator review including root cause analysis for identification of underlying causes of outliers and trend analysis.
- May support or provide input into clinical system development activities including data lake mapping.
- May be responsible for local lab normal range data entry activities and identification and documentation of data problems during lab normal range tracking.
- May participate in sponsor and/or thirdparty audits.
Qualifications
- Basic skill in aggregate data review and interpretation using visualization/analysis software e.g., JReview, Tableau, SAS.
- 1 year of relevant experience
- Strong skill in utilization of computerized information systems and standard application software, e.g., Windows, MS Office
- Bachelor’s degree in relevant field of study
- Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above
Benefits of Working in ICON:
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.
At 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.
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, color, 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.