Senior Manager

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.

 

Senior Manager

Department: Data Management

Job Responsibilities:

  • 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.

Qualifications:

  • 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 jenny.zhang@crmedicon.com.