武汉招聘

Job Description Manager, Clinical Programming
August 22, 2014 Confidential P a g e 1
General Summary General Summary General SummaryGeneral SummaryGeneral SummaryGeneral Summary General SummaryGeneral SummaryGeneral SummaryGeneral SummaryGeneral Summary
Managers of Clinical Programming provide leadership and high-level expertise to the Clinical Programming group. They are responsible for coordinating all activities and personnel within clinical programming, for mentoring clinical programmers across multiple project teams, along with performing resource allocation and timeline coordination. They oversee project teams that contribute to data tabulations, statistical analyses, clinical development, and regulatory submissions. They supply expert advice on complex problems where analysis of situations or data requires an evaluation of intangible variables. They develop solutions to abstract problems within existing systems and processes where feasible, and utilize ingenuity and creativity to develop additional new solutions. Managers of Clinical Programming lead initiatives to develop standards, systems and procedures. The work requires an understanding of the theories and methodologies behind the conversion, tabulation, analysis, reporting, and integration of clinical data. It requires the ability to apply knowledge of the SAS® statistical programming application and other software languages and tools along with knowledge of industry-accepted standards, including CDISC SDTM and ADaM. Managers of Clinical Programming ensure that staff members fulfill responsibilities in accordance with WuXi PRA policies, procedures, SOPs, ICH〨CP guidelines, local regulatory authority regulations, and client requirements.
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？ Oversee clinical programming activities for Phase I-IV studies, integrated databases and analyses, safety reviews and ad-hoc analyses.
？ Develop and manage programming services; providing programming resources and project management of clinical programming activities and deliverables.
？ Establish and maintain strategic client relationships including support of corporate business development and marketing activities at client presentations and professional seminars.
？ Supports the leadership of Data and Programming Services on short-term and long-term strategies to improve efficiencies in Clinical Programming, through collaboration with senior management.
？ Use all information available and proactively seek required information to predict resource requirements and recruitment needs.
？ Maintain awareness of and disseminate new developments in programming techniques and standards which may be applied to the management and reporting of clinical trial data.
？ Provide input into budgetary requirements; perform ongoing financial review of assigned projects; promptly identify, communicate, and manage both risks and issues; and support the project team to ensure all out-of-scope tasks are identified, tracked and included in change order forms.
？ Maintain utilization of all clinical programming staff within department goals.
？ Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion.
？ Ensure quality work within the group and department through ongoing review and improvement of processes and procedures to ensure high quality deliverables to clients and internal customers.
？ Ensure staff are mentored and trained appropriately; foster career development and self-improvement of staff; develop future managers.
？ Recruit and retain high quality employees.
？ Identify departmental initiatives to provide process and technical efficiencies for clinical programming, ensuring global clinical programming awareness and resolution.
？ Promote and positively raise the profile of WuXi PRA and its services externally through active participation with external bodies and membership organizations, supporting business development activities and recruitment.
？ Other tasks as assigned.
Job Description Manager, Clinical Programming
August 22, 2014 Confidential P a g e 2
Job Factors Job Factors Job FactorsJob Factors Job FactorsJob FactorsJob Factors
Applied Knowledge & Skills
？ Strong mentoring and leadership skills.
？ Ability to identify and hire strong candidates through hiring processes.
？ Ability to enhance individual performance through feedback and encouragement.
？ Able to assess the hours required for multiple projects, assign them to staff in order to balance departmental resource.
？ Comprehensive knowledge of WuXi PRAs SOPs and other policies and processes required by functional managers.
？ Comprehensive knowledge of industry standards (for example CDISC).
？ Can communicate complex technical considerations to nontechnical staff.
？ Applies excellent knowledge of clinical data, SAS® programming language, or other software languages/ tools as required.
Problem solving Fact Finding & Analysis
？ Proactively works with project teams to research project timelines and requirements.
？ Uses tools to identify resource shortfalls or overages.
？ Uses data to present ideas and concerns.
？ Performs root cause analysis of projects with quality, timelines or budget problems and works to correct them.
Impact
？ Errors in resourcing may have impact on project timelines, quality and budget.
？ Errors in leadership and mentoring may cause increased turnover.
？ Lack of good leadership will result in failure to meet team goals.
？ Inability to communicate complex technical issues will lead to frustrated clients and project teams.
Supervision Given / Received
？ Performs routine management tasks with little or no assistance.
？ Handles project and team performance issues with some assistance.
？ May require assistance developing more complex and involved plans.
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Education
？ Undergraduate degree or its international equivalent from an accredited institution.
Experience
？ 5 years of experience performing Clinical Programming tasks including creating tabulation and analysis datasets and TFLs etc.
？ 2 years of experience of working in a multinational environment.
？ Demonstrated ability in leading development initiatives to successful conclusion.
？ Previous line management experience.
Preferred Education and/or Experience
？ Advanced degree (e.g., M.S., M.B.A., Pharm.D.) Proven skills with industry standards

WuXi PRA Clinical Research (Shanghai) Co., Ltd. offers comprehensive Phase I-IV clinical trial services in Mainland China, Hong Kong and the Asia region. With 5 offices and staff based in 17 cities across China, WuXiPRA’s locally based project teams operate with the support of PRA’s global resources, clinical research expertise, global technologies and SOPs. This centralized operational approach promotes higher quality and outstanding client service. WuXiPRA has invested significantly in staff focused on CFDA regulatory expertise, project management and clinical informatics resources, as well as other support services, including RPS embedded strategic outsourcing.

上海康德保瑞医学临床研究有限公司在中国内地、香港及亚洲地区提供全方位的I-IV期临床试验服务。 康德保瑞在中国有5个办公室，员工分布在17个城市，其团队拥有保瑞医药丰富的全球资源和临床研究专业知识以及全球化的技术和标准操作规程支持。这些有助于全球性、区域性以及本土的临床试验运作达到更高的质量。康德保瑞在人员方面投入巨大，主要集中在CFDA注册专业知识、项目管理、临床信息资源以及包括战略外包服务的其它支持服务方面。