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:
- The Senior Clinical Data Manager will serve in a support‐level capacity on a Clinical Data Management team to provide efficient and quality clinical data management products.
- Support the design, specifications, and development of eCRFs, ensuring adherence to Biogen standards throughout.
- Coordinate the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities.
- Support the development of Data Management Plan documents that will ensure delivery of accurate, timely, consistent, and high‐quality clinical data.
- Works with Third Party /External data Vendors to complete the set‐up of data import and reconciliation processes.
- Perform comprehensive review of all data generated from the clinical study including Third Party/External data, SAE data and local lab data, as applicable.
- Oversees quality control procedures. Develop and maintain strong communications and working relationships with CDM team.
- With guidance from Principal Clinical Data Lead or Manager, effectively manage project timelines and quality.
- Provide reports, status updates, feedback, and advice to key study stakeholders on the progress of data cleaning and risk identification/mitigation activities.
- Ensure CDM activities are performed in compliance with Good Clinical Practice, ICH Guidelines, Biogen SOPs, Job Aids, regulatory guidelines, and study specific plans.
- Apply appropriate best practices and independently offer project solutions to the study team.
- Ensures activities that are performed are done in line with study timelines, with quality and in compliance with governing process.
- Support the filing of eTMF documentation to ensure that an inspection ready environment is maintained throughout the study lifecycle.
- Supports and assists Subordinate staff for assigned trials. Impacts quality, timeliness, and effectiveness of the team.
- Provide back up support for Principal Clinical Data Lead as required.
You Possess;
- Bachelor’s degree preferred, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
- 5+ years of Clinical Data Management experience.
- Ability to work under pressure demonstrating agility through effective and innovative team leadership.
- Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as elluminate, J‐Review or Business Objects required.
- Deep understanding of drug development and biopharmaceutical industry required.
- Strong technical skills, including experience working with using Microsoft Excel functionality.
- Fluent English (oral and written).
- Strong understanding of drug development and biopharmaceutical industry required.
- High attention to detail including proven ability to manage multiple, competing priorities.
- Excellent written and oral communication skills.
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.
