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.
What you will be doing:
- Serve as a Clinical Data Reviewer and identify any errors in data by performing data review that require further clarification with the study sites
- Perform ongoing review of clinical/medical aspects of assigned patient data and documents
- Communicates any data training needs for CRAs, sites, etc
- Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
- Provide clinical data Project Management and viewed as an expert in data clinical/medical review and cleaning.
- Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation
- May assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements.
- May be closely involved in data review and identification of readiness for clinical narratives for CSRs
- May participate in clinical data review meetings such as:
o Protocol Deviation review
o Data Review and Quality Team (DRQT)
o Statistical Review of Clinical Data (SRCD)
o Safety Monitoring Team (SMT) review
o Slide preparation of top-line results
You are:
- Educational scientific background such as MD, PharmD, PhD, Nursing degree, MS
- 5 years of pharmaceutical clinical/medical data review experience is required, including clinical crosscheck experience. 8+ years is preferrable
- Experience with Solid Tumor Oncology
- Excellent verbal and writing communication in English, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
- Experience in coding review
- Query writing training
- Strong clinical database navigation skills
- Strong MS excel, project management
- Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process
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.
