Senior Database Developer

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

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