||Senior Database Developer
||Clinical & Regulatory Department
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.
- 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.
- 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 firstname.lastname@example.org