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1、ProgramandApplicationDeveloper岗位职责职位要求职责描述： KEY TASKS & RESPONSIBILITIES A.Trial activities: Prepare annotated CRFs /e-CRFs as necessary Develop, validate, document, and maintain software required to conduct or support data management related activities primarily in the context of clinical trials, p
2、rojects or programs, such as programs for data extracts from Oracle to SAS datasets, DQSPs, Patient Profiles, required reports or listings or figures, creation of define.xml and conversion programs to SDTM (including modifications during Trial Conduct), if applicable and under supervision of Line Ma
3、nagement, perform surveillance of above mentioned programming activities when conducted by in-sourced staff or staff working in off-shores Provide input into CRF specifications, data transfer specifications, database design, and query check specifications through review of protocol, CRF, the data ma
4、nagement plan, data management report, data validation plan, and data quality surveillance plan, whatever is applicable Run DQSPs, edit checks, reports or listings and data extracts on clinical data according to timelines communicated by the Trial Data Manager if needed Perform electronic data loads
5、 into Oracle, downloads from Oracle to SAS datasets and store SAS datasets (including CRO deliverables) in the appropriate storage location in the SAS environment Provide relevant documentation and data for archiving Assign/restrict access rights to clinical trial databases Lock/unlock databases as
6、requested B. Non trial activities: o System maintenance/enhancements and process improvements Contribute to the continuous improvement, re-engineering and implementation of processes, tools, technologies, conventions, standards, policies, Standard Operating Procedures (SOPs), and Working Instruction
7、s as needed Develop and modify edit checks as needed for the standard global library Create, validate and maintain globally re-usable programs /macros that streamline repetitive operations Program administrative reports as needed for clinical trials Interface with SAS technical support to resolve so
8、ftware problems Communicate technical programming concepts in a clear, concise and focused manner. Under the supervision of Line Management, plan, communicate, and implement the surveillance of the programming activities performed by a Contract Research Organizations, in-sourced staff or staff worki
9、ng in off-shores Develop experience and skills in new systems when necessary o Training Providing Mentor more junior APDs in all aspects of the GCDS process Train / give guidance to GCDS staff on the use of the applications (existing and new ones) Assist with training of APDs / in-sourced staff / st
10、aff working in off-shores o Training Receiving Keep up to date with job related topics, in particular with regard to SAS and SQL Be up to date with SOPs, , and user manuals and maintain training log CANDIDATES PROFILE EDUCATION/LANGUAGES Basic, Bachelor or Master of Science (preferably in a numerate
11、 discipline such as Statistics, Computer Science, or Mathematics) degree in health related field and/or computer science or equivalent Excellent knowledge of English (French or German is a plus) PROFESSIONAL SKILLS & EXPERIENCE Experience in clinical data management / statistics / statistical progra
12、mming in the pharmaceutical/biotechnology industry, equivalent to -4 years Expertise in SAS/BASE, SAS/Macro, SQL (knowledge of other SAS modules is a plus) Knowledge of Oracle, Web based EDC,HTML, XML, VBSCRIPT is a plus Knowledge of CDISC in general and comprehension of SDTM and define.xml (ADaM is
13、 a plus) Knowledge of regulations and guidances with regard to clinical development, the systems used in this context and data management related aspects of e-submissions PERSONAL SKILLS & COMPETENCIES Excellent written, verbal and organization skills Ability to handle multiple projects Excellent te
14、am player, works effectively in international teams, and multi-disciplinary groups. Excellent accuracy and attention to detail Ability to understand customer requirements and convert them into realizable packages. Potential to develop solutions and optimize processes. Well-organized, high-quality targeted. Mentoring and training skills. 岗位要求： 学历要求：不限 语言要求：不限年龄要求：不限工作年限：无工作经验
