Website CR Medicon
CR Medicon is a clinical development CRO dedicated to providing high-quality services including regulatory affairs, medical affairs, clinical operation, data management, statistical analysis, programming, and biological sample analysis. We are the most trusted and fastest-growing clinical trial service provider/partner for both domestic and overseas sponsors.
Department: Data Management
- Responsible for ensuring the completeness, quality and integrity of the Clinical Trial data.
- 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/WI (work instructions) of CR Medicon and/or Sponsor.
- Ensure acknowledge, follow and to be consistent with CR Medicon policies and procedures.
- Act as Lead Data Manager for multiple ongoing clinical studies. Ability to train junior Clinical Data Managers and assign tasks as required.
- Ability to create, maintain DM Timelines.
- Responsible for leading team activities with the sponsor. Responsible for creating and maintaining the Global Library.
- Responsible for maintaining eTMF and TMF (where applicable). 11. Hands-on data management responsibilities but not limited to:
- CRF collections, maintenance and tracking.
- User acceptance testing (UAT) for database.
- Perform data cleaning activities including discrepancy management (review of errors from electronic checks) and manual review (review of data listings to verify quality and completeness of data).
- 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.
- Run ancillary reports as necessary.
- Experience with database setup and database lock activities. Participate internal/external functional meetings as required.
- Peer Review Study documents as required.
- Serve as client contact for project meetings and DM status updates.
- Interact and collaborate with other project and cross-functional team members including clinical, programming, statistics, database manager, medical coder, etc.
- Train end users on data collection tools.
- 5+ years of experience in the Data Management field, experience of managing CROs and Data Management vendors is required, working in a global/cross cultural setting is preferred.
- Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation.
- Advanced knowledge of clinical database design is a must. RAVE experience preferred.
- Knowledge of FDA/ICH guidelines and industry standard practices regarding programming.
- Knowledge of SQL and SAS programming.
- Excellent oral and written communication skills in English.
- Strong problem-solving and time management skills.
- Team lead experience and ability to manage groups of data managers to ensure timely completion of clinical studies.
- High degree of enthusiasm and a strong sense of responsibility.
- Adapt to work with highly-accurate, high attention of details, and strict quality control.
- Ability to work in cross-functional team setting as well as independently.
- Ability to multitask and balance several ongoing projects.
- Oncology Study experiences are a plus.
If you are interested in this position, please contact Jenny Zhang firstname.lastname@example.org.