Note: The job is a remote job and is open to candidates in USA. Charles River Laboratories is a contract research organization supporting drug development and safety assessment. The Clinical Data Manager I manages clinical trial data for multiple projects, ensuring accurate and timely reporting while coordinating with site operations, clients, and internal and external stakeholders throughout the clinical data life cycle.
Responsibilities
- Request requirements from the sponsor for transfer frequency and dataset architecture for data transferred to sponsors in support of clinical study work
- Prepare and/or review Data Transfer Agreements for basic assay data types (E.g. PK, Biomarker)
- Oversee preparation of the Study Data Tabulation Model (SDTM) and non-SDTM datasets for a clinical study
- Perform quality control on all aspects of the clinical study as appropriate, to include, but not be limited to clinical regulatory compliance, Data Transfer Agreements, creation of clinical programming specifications, review of external client(s) clinical study documentation, review and management of data corrections via reconciliation requests from external client(s)
- Confirm clinical datasets are prepared and transferred to the sponsor in compliance with applicable regulations
- Support peers in secondary document review and quality control activities for their assigned projects
- Transfer datasets utilizing acceptable data exchange locations, such as internal or external data portal locations
- Attend and/or host internal or external meetings as appropriate
- Keeps internal and external stakeholders informed of strategy, plans and changes as needed to provide quality products and services
- Responsible for assigned study schedules and for coordinating internal and external resources
- All other duties as assigned
Skills
- * Education: Bachelor's Degree (B.S./B.A.); scientific discipline preferred
- * Experience: 3-5 years in a research or pharmaceutical environment; data management experience preferred
- * An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- * Familiarity with CDISC's CDASH, SDTM, and Controlled Terminology Standards
- * Familiarity with various data output formats (.xml, .xpt, sas7bdat, ASCII, text, .DAT, .xlsx)
- * Knowledge of Microsoft Office Suite and ability to perform basic computer functions commensurate with the job responsibilities
- Excellent organizational skills and the ability to meet deadlines
- * Excellent communication (both written and verbal), and collaboration skills
- * Ability to interact appropriately with clients and all levels of employees, while at the same time support the efforts of departmental teams
- * Certification/Licensure: No specific certifications or licensure required
- Four-year degree required
Benefits
- Bonus/incentives based on performance
- 401K
- Paid time off
- Stock purchase program
- Health and wellness coverage
- Employee and family wellbeing support programs
- Work life balance flexibility
Company Overview
Company H1B Sponsorship