Senior Clinical Data Science Lead
ICON plc
Clinical Data Science Lead
ICON plc
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Support the design, specifications, and development of eCRFs, ensuring adherence to 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, 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.
- Provide back up support for Principal
Requirements
- 4+ years of Clinical Data Management experience
- 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)
- High attention to detail including proven ability to manage multiple, competing priorities
- Excellent written and oral communication skills
- Bachelor’s degree preferred, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
