Senior Manager, Data Science
Walmart
PythonSparkSQL
Clinical Data Science Lead
ICON plc
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Support the design, specifications, and development of eCRFs ensuring adherence to standards
- Coordinate development and testing of clinical data management system edit checks and listings/reports/tools for data review and discrepancy management
- Support development of Data Management Plan documents to ensure accurate, timely, consistent, high-quality clinical data
- Work with Third Party/External data vendors to set up data import and reconciliation processes
- Perform comprehensive review of all study data including Third Party/External data, SAE data and local lab data
- Oversee quality control procedures and support filing of eTMF documentation to maintain inspection-ready environment
- Develop and maintain communications and working relationships with CDM team and study stakeholders
- Manage project timelines and quality with guidance from Principal Clinical Data Lead or Manager
- Provide reports, status updates, feedback, and advice on data cleaning and risk identification/mitigation
- Ensure CDM activities comply with GCP, ICH, SOPs, Job Aids, regulatory guidelines, and study specific plans
- Support and assist subordinate staff and provide backup support for Principal
Requirements
- 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)
- Experience with Data Review tools such as elluminate, J-Review or Business Objects
- Deep understanding of drug development and biopharmaceutical industry
- Strong technical skills, including Microsoft Excel functionality
- Fluent English (oral and written)
- High attention to detail and proven ability to manage multiple, competing priorities
- Excellent written and oral communication skills
- Bachelor’s degree preferred (Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.)
