Location: Remote (United States)
Salary: $85,000 - $110,000
About the Opportunity
Our client provides comprehensive clinical development services, including drug registration, medical affairs, clinical operations, data management, statistical analysis, and biological sample analysis. All performed by a team that consists of elites and experts from our industry.
- Ensure data quality and consistency according to applicable regulatory requirements, standard operating procedures (SOPs), processes and data standards.
- Ensure all data management activities to be compliance with GCP, relevant regulatory requirements and SOP
- Act as Lead Data Manager for multiple ongoing clinical studies.
- Ability to train junior Clinical Data Managers and assign tasks as required.
- Responsible for leading team activities with the sponsor, creating and maintaining the Global Library and maintaining eTMF and TMF (where applicable).
- CRF collections, maintenance and tracking.
- Create the relevant documentations/files, e.g., Case Report Forms, Data Management Plan, Edit Check Specification, Data Review Plan, UAT Plan, Data Transfer Specification, and CRF Completion Guidelines, etc.
- Interact and collaborate with other project and cross-functional team members including clinical, programming, statistics, database manager, medical coder, etc.
- Bachelor’s Degree or higher in life sciences or related field.
- 5+ years of industry experience with TA experience in oncology.