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Clinical Operations and Regulatory Affairs, Shanghai | 30 Sep 2021

Senior Database Developer

Job Title: Senior Database Developer
Department/Group: Clinical & Regulatory Department
Location: Shanghai

 

Primary Functions

Responsible for executing end to end clinical database setup and management activities pertaining to clinical trials, including but not limited to: database setup and SAS programming development activities in compliance with Hutchmed Standard Operating Procedures (SOPs) and ICH-GCP guidelines, oversee the process and quality of DBD work contracted to a CRO.
 

Major Responsibilities and Duties

  • Provide database setup service and SAS programming development service for clinical trials;
  • Contribute to the review, maintenance, and ongoing update database setup and SAS programming in accordance with the database User Acceptance Test (UAT);
  • Develop the System Edit Check (EC) and SAS Edit Check (EC) in accordance with the Data Validation Plan (DVP);
  • Maintain and update System EC in accordance with the EC UAT results;
  • Assist in review of study-specific demands including aCRF, database specs, DVP, SAS listing, and customized report specifications;
  • Perform database configuration, access management, and training for assigned trials;
  • Contribute to the eCRF development, annotation, modification, and database maintenance activities;
  • Assist in the development of database training for assigned trials;
  • Participate in the development and implementation of database technology or tool;
  • Understanding of ICH-GCP and CDISC principles;
  • Perform other activities as required.

 

Qualifications

  • Specialized Knowledge:
    • Clinical Data Management System experience (e.g., RAVE, Clinflash, Inform, OC RDC) and understanding of database/programming concepts.
    • Knowledge of the clinical development process.
    • Knowledge of industry standards and practices, e.g. CDISC.
  • Minimum Requirements:
    • Educated to at least Bachelor level in IT, Medicine, Pharmacy, Biological Sciences, or health care related disciplines.
    • At least 5-year DBD experience in pharmaceutical company or Clinical Research Organization (CRO)
  • Preferred Requirements:
    • Familiarity with other clinical database tools like CTMS, IRT/RTSM, ePRO, IRC/MIRS,and PV/ Argus
    • Prior experience with SAS programming is preferred;
    • Strong programming skills in C++, Java, or Python is preferred;
    • Able to work under pressure and in a changing environment with flexibility;
    • Good communication skills with the ability to communicate with both the technical and business areas.

 

Internal-External Relations

  • Internal:
    • Project team within HMP.
  • External:
    • CRO/vendors, consulting experts, co-development/business partners as appropriate;
    • Must be prepared to describe and demonstrate the job attributes to regulatory authority inspectors during regulatory authority inspections.

 
If interested, please forward your resume to winniew@hutch-med.com