长沙招聘

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, projects or programs, such as programs for data extracts from Oracle to SAS datasets, DQSP’s, 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 Management, 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 management 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 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 requested

B. Non trial activities:

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 Instructions (WIs) 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 software 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 working in off-shores

· Develop experience and skills in new systems when necessary

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 / staff working in off-shores

Training – Receiving

· Keep up to date with job related topics, in particular with regard to SAS and SQL

Be up to date with SOPs, WIs, and user manuals and maintain training log



Requirements:

EDUCATION/LANGUAGES

Basic, Bachelor or Master of Science (preferably in a numerate 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 programming 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 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 team 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.

默克雪兰诺有限公司
默克雪兰诺是总部位于德国达姆施塔特的全球医药和化工集团默克公司旗下生物制药业务分支。默克雪兰诺总部设在瑞士日内瓦，致力于发现、开发、生产和销售针对特定适应症的化学和生物的处方药。北美业务在美国和加拿大以EMD 雪兰诺的名称运营。

默克雪兰诺中国总部位于北京，拥有员工约1200人，业务遍及全国。目前，默克雪兰诺在中国经营9个领域18种药品，在未来几年里，还将上市多种新药。