ICON plc
Senior Clinical Data Manager
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Senior Clinical Data Manager
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
As a Clinical Data Science Lead at ICON, you will drive data science initiatives within clinical trials, ensuring that our analyses provide meaningful insights that inform strategic decisions.
Key Responsibilities:
- 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 company standards.
- 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.
- 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.
- Apply appropriate best practices and independently offer project solutions to the study team.
- Support the filing of eTMF documentation to ensure that an inspection ready environment is maintained throughout the study lifecycle.
- Provide back up support for Principal Clinical Data Lead as required.
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Your Profile:
- 4+ 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
- Experience in Phase I/II
- Neurology experience would be desirable.
- Extensive experience in Study startup.
- 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
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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply.
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