公司部门: Clinical Development
1. Utilizes primary development tools including Medidata, Rave, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
2. Oversight CRO to generate and maintain all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.
3. Oversight CRO to serve on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
4. Provides technology support to the CRO clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports
5. Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: MDSOL Rave, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions.
6. Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits.
7. Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed.
8. Guidance CRO to perform system integration activities, application updates, and user acceptance testing.
9. Assists in project meetings and actively contributes and participates in departmental review meetings.
10. Manages project resources, proactively alerting management of delivery and resourcing needs.
11. Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.
1. Bachelor’s degree preferred, or equivalent combination of related education and experience.
2. The ability to deal effectively with CRO programmer and internal study team members at all levels.
3. Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.
4. Demonstrated experience in managing multiple priorities in a highly dynamic environment
5. Experience working in a matrix-structured environment is preferred