Medical Data Reviewer
- France, Germany, Ireland, Netherlands, Spain, UK
- ICON Strategic Solutions
- Biometrics Portfolio
About the role
This vacancy has now expired. Please see similar roles below...
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Read more
Day in the life
Teaser label
Inside ICONContent type
BlogsPublish date
01/28/2015
Summary
ICON began its journey to international success from humble beginnings in Ireland in 1990. Started by Dr John Climax and Dr Ronan Lambe, the first office had five team members and since then has grown
Similar jobs at ICON
Salary
Location
Bangalore
Department
Biometrics Roles
Location
Bangalore
Business Area
ICON Strategic Solutions
Job Categories
Biometrics Portfolio
Job Type
Permanent
Description
As a Senior Clinical Data Science Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114703
Expiry date
01/01/0001
Author
Abhisikta MishraAuthor
Abhisikta MishraSalary
Location
Bangalore
Department
Biometrics Roles
Location
Bangalore
Business Area
ICON Strategic Solutions
Job Categories
Biometrics Portfolio
Job Type
Permanent
Description
ICON PLC is seeking a highly skilled and experienced Principal Clinical Data Science Programmer to join our team in Bangalore/Chennai (Officebased). The ideal candidate will have over 4 years of exper
Reference
2024-114275
Expiry date
01/01/0001
Author
Abhisikta MishraAuthor
Abhisikta MishraSalary
Location
Chennai
Department
Biometrics Roles
Location
Chennai
Business Area
ICON Strategic Solutions
Job Categories
Biometrics Portfolio
Job Type
Permanent
Description
As a Medical Coding Specialist (Chennai, India ~ Office-based)you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114210
Expiry date
01/01/0001
Author
Abhisikta MishraAuthor
Abhisikta MishraSalary
Location
India
Department
Biometrics Roles
Location
India
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Biometrics Portfolio
Job Type
Permanent
Description
As a Senior SDTM Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114221
Expiry date
01/01/0001
Salary
Location
Kenya, Estonia, Hungary, Ireland, Lithuania, Poland, South Africa
Department
Biometrics Roles
Location
Estonia
Hungary
Ireland
Lithuania
Poland
South Africa
Kenya
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Biometrics Portfolio
Job Type
Permanent
Description
ICON PLC is seeking a highly skilled and experienced Senior Lead Clinical Data Science Programmer to join our team. The ideal candidate will have over 4 years of experience working within Data Warehou
Reference
2024-114271
Expiry date
01/01/0001
Author
Jack FisherAuthor
Jack FisherSalary
Location
Chennai
Department
Biometrics Roles
Location
Chennai
Business Area
ICON Strategic Solutions
Job Categories
Biometrics Portfolio
Job Type
Permanent
Description
The Senior CDC/ CDC II is the point of contact for day to day activities on a study with key responsibilities to handle the study independently. Support clinical data managers on external data transfe
Reference
2024-114198
Expiry date
01/01/0001
Author
Abhisikta MishraAuthor
Abhisikta Mishra