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.
The Medical Data Reviewer (MDR) sets up and coordinates the medical data review process, assists with medical data review and manages medical queries. The MDR role requires a close collaboration with various members of the Medical and Biometrics team, most frequently but not limited to Medical Doctor (MD), Clinical Research Scientist (CRS), and Lead Data Manager (LDM).
What you will be doing:
- Responsible for ensuring the high quality medical review of phase I/II oncology clinical trial data, in compliance with GCP/ICH and regulatory requirements
- Provide high quality, timely and diligent clinical data review to ensure adequate data quality for the ongoing clinical development lifecycle
- Conducts medical review of the data as per Medical Data Review Plan (MDRP) on incremental listings and subject profiles in close collaboration with MD/CRS
- Reviews and approves all test outputs of listings/profiles in collaboration with the MD/CSR and Biometrics team
- Participates in/attends internal and external relevant meetings, as needed
- Provides input into the electronic Case Report Form (eCRF) and CRF Completion Guidelines (CGS), Medical Data Review Plan (MDRP) and related relevant documents
- Collaborate with relevant line functions to improve the quality of clinical data review/insights with an emphasis on subject safety and eligibility, efficacy endpoints, data integrity, trend identification, analysis and remediation, and identification of cases for medical review
- Assist in the development and monitoring of the data review strategy, ensuring that clinical data review findings are adequately implemented and resolved, leading to a front-loaded data cleaning and high quality study data
You Possess;
- Degree in life sciences/healthcare (or clinically relevant degree) is required. PhD, MBBS, BDS, MD strongly preferable
- 3 years (minimum) experience in Pharmaceutical industry/Clinical Research Organization, as a Medical Data Reviewer, Medical Monitor or similar roles
- Fundamental knowledge of Good Clinical Practice, clinical trial design including eCRF design, medical data review, statistics, regulatory processes, and clinical development process in Oncology
- Basic knowledge in planning, executing, and reporting global oncology clinical studies in a Pharmaceutical company or Contract Research Organization
- Proficient English (oral and written)
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.
