Clinical Research Project Planner
辉瑞(中国)研究开发有限公司
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2012-08-23
- 工作地点:上海
- 招聘人数:若干
- 工作经验:一年以上
- 学历要求:本科
- 语言要求:英语熟练
普通话熟练 - 职位类别:临床研究员 临床数据分析员
职位描述
Position Purpose:
*Accountable for generation and maintenance of study/project schedules and study/project resource forecasts within the company system to support entire global Research Unit (RU) and Business Units' Clinical Pharmacology portfolio.
*Ensure project plans are created the company system based on defined global configuration, standards & target timing goals.
*Interfaces with protocol team members as well as others lines within DevOps and Alliance Partners, Pharmaceutical Sciences, Drug Safety Research & Development and across Worldwide Research and Development and the Business Units.
*Responsible for maintaining accurate schedule, resource and budget information within systems used for reporting and portfolio management.
*Produce various levels of schedules/plans and other related reports to support project teams as well as management.
*Responsible for performing project critical path analyses, scenario planning of timelines & resource demand within & across protocols to enable optimum use of resources & efficient delivery of project milestones.
Primary Duties:
Planning / Controlling: (Scheduling & Capacity Management):
*Partners with the Clinical Research Operations Strategy Leads (CROSL) and/or Project Manager in Alliance Partners to create study/project plans that enable effective planning and forecasting of FTE and dollar resources, (including high level and detailed schedules as appropriate) in the company system.
*Directly accountable for coordinating, monitoring and reporting study/project schedule to enable alignment of line and project resources.
*Accountable for accurate and timely updates to study level project schedules and resource information to enable the preferential use of resource in Pfizer Clinical Research Units (PCRUs), Alliance Partners (AP) and biometrics functions at CRDC.
*Raises schedule conflict issues appropriately for resolution.
*Directly participate in and contribute to functional and cross-functional teams to discuss, review, and optimize protocol/project/program schedules, and resource management plans.
*Monitors progress of study/project activities towards next project milestone, anticipates and highlights potential variances.
*Supports critical path analyses and identifies/recommends solutions to issues or slippages.
*May perform scenario planning of timelines & resource demand within & across protocols to enable optimum use of all available resources and ensuring efficient delivery of project milestones.
*Validates resource information at the protocol/project level with the project teams.
*Collaborates with appropriate DevOps lines to evolve global resource algorithms.
*Responsible for creating and maintaining study level plan templates to enable consistent, streamlined and effective planning of entire global RU and BU Clinical Pharmacology studies.
Process:
*Partner with the CROSLs and study team to identify opportunities and potential solutions to realize efficiency in the development process.
*Contribute to continuous improvement of project plan generation, utilization and report delivery
*Collaborate with line colleagues to ensure cross-team & site learnings and best practices are shared globally.
*Work with other Project Planners and across lines to improve and enhance the design and development of planning and resourcing tools, templates and guidelines.
*Provide training & mentorship to new and established users in planning and resource systems, and associated operating procedures and reporting.
Analysis & Reporting:
*Responsible for quality of schedule & resource data through review of quality reports and monitoring/management of the plan with the team / line members.
*Provides timely reporting to line managers, CROSLs and study teams, alerting them to the possibility of endangered/missed or conflicting milestones, as well as critical path activities.
*Ensures regular information updates, analysis and interpretation of planning and forecasting to study teams and line managers.
*Facilitate use of existing reporting tools by customer base e.g. Business Objects, and other tools such as Merlin.
Provide context to local customers of reports generated globally and consolidates customer feedback to enable improvement of existing reports and generation of new reports.
*Produce what-if scenario analyses (base, optimistic and pessimistic development) based on context derived from the CROSLs or line management.
*Establish plan baselines, facilitate use of variance with study teams to determine root cause and potential mitigation plans.
*Utilize metric tools/reports to facilitate analysis of team accomplishments according to plans.
Education & Prior Experience Preferred:
*Bachelor's degree in one of the disciplines related to drug development or equivalent business experience is preferred
*Previous project planning/ project management or related experience, preferably within clinical trials
*Experience in negotiation, facilitation and managing matrix team dynamics
*All vary with Career Ladder level with increasing competence expected at more senior grades and with greater emphasis on assessment of Experience within the pharmaceutical or biotechnology industries is preferred
*Clinical development and business experience in order to have a through understanding of the processes associated with clinical and regulatory operations
*Excellent proficiency in verbal and written English
*Customer focused and solution oriented
*Excellent organizational and interpersonal skills
*Excellent presentation and communications skills
*Strong collaboration skills
*Financial and resource management experience
*Accountable for generation and maintenance of study/project schedules and study/project resource forecasts within the company system to support entire global Research Unit (RU) and Business Units' Clinical Pharmacology portfolio.
*Ensure project plans are created the company system based on defined global configuration, standards & target timing goals.
*Interfaces with protocol team members as well as others lines within DevOps and Alliance Partners, Pharmaceutical Sciences, Drug Safety Research & Development and across Worldwide Research and Development and the Business Units.
*Responsible for maintaining accurate schedule, resource and budget information within systems used for reporting and portfolio management.
*Produce various levels of schedules/plans and other related reports to support project teams as well as management.
*Responsible for performing project critical path analyses, scenario planning of timelines & resource demand within & across protocols to enable optimum use of resources & efficient delivery of project milestones.
Primary Duties:
Planning / Controlling: (Scheduling & Capacity Management):
*Partners with the Clinical Research Operations Strategy Leads (CROSL) and/or Project Manager in Alliance Partners to create study/project plans that enable effective planning and forecasting of FTE and dollar resources, (including high level and detailed schedules as appropriate) in the company system.
*Directly accountable for coordinating, monitoring and reporting study/project schedule to enable alignment of line and project resources.
*Accountable for accurate and timely updates to study level project schedules and resource information to enable the preferential use of resource in Pfizer Clinical Research Units (PCRUs), Alliance Partners (AP) and biometrics functions at CRDC.
*Raises schedule conflict issues appropriately for resolution.
*Directly participate in and contribute to functional and cross-functional teams to discuss, review, and optimize protocol/project/program schedules, and resource management plans.
*Monitors progress of study/project activities towards next project milestone, anticipates and highlights potential variances.
*Supports critical path analyses and identifies/recommends solutions to issues or slippages.
*May perform scenario planning of timelines & resource demand within & across protocols to enable optimum use of all available resources and ensuring efficient delivery of project milestones.
*Validates resource information at the protocol/project level with the project teams.
*Collaborates with appropriate DevOps lines to evolve global resource algorithms.
*Responsible for creating and maintaining study level plan templates to enable consistent, streamlined and effective planning of entire global RU and BU Clinical Pharmacology studies.
Process:
*Partner with the CROSLs and study team to identify opportunities and potential solutions to realize efficiency in the development process.
*Contribute to continuous improvement of project plan generation, utilization and report delivery
*Collaborate with line colleagues to ensure cross-team & site learnings and best practices are shared globally.
*Work with other Project Planners and across lines to improve and enhance the design and development of planning and resourcing tools, templates and guidelines.
*Provide training & mentorship to new and established users in planning and resource systems, and associated operating procedures and reporting.
Analysis & Reporting:
*Responsible for quality of schedule & resource data through review of quality reports and monitoring/management of the plan with the team / line members.
*Provides timely reporting to line managers, CROSLs and study teams, alerting them to the possibility of endangered/missed or conflicting milestones, as well as critical path activities.
*Ensures regular information updates, analysis and interpretation of planning and forecasting to study teams and line managers.
*Facilitate use of existing reporting tools by customer base e.g. Business Objects, and other tools such as Merlin.
Provide context to local customers of reports generated globally and consolidates customer feedback to enable improvement of existing reports and generation of new reports.
*Produce what-if scenario analyses (base, optimistic and pessimistic development) based on context derived from the CROSLs or line management.
*Establish plan baselines, facilitate use of variance with study teams to determine root cause and potential mitigation plans.
*Utilize metric tools/reports to facilitate analysis of team accomplishments according to plans.
Education & Prior Experience Preferred:
*Bachelor's degree in one of the disciplines related to drug development or equivalent business experience is preferred
*Previous project planning/ project management or related experience, preferably within clinical trials
*Experience in negotiation, facilitation and managing matrix team dynamics
*All vary with Career Ladder level with increasing competence expected at more senior grades and with greater emphasis on assessment of Experience within the pharmaceutical or biotechnology industries is preferred
*Clinical development and business experience in order to have a through understanding of the processes associated with clinical and regulatory operations
*Excellent proficiency in verbal and written English
*Customer focused and solution oriented
*Excellent organizational and interpersonal skills
*Excellent presentation and communications skills
*Strong collaboration skills
*Financial and resource management experience
公司介绍
On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外,该中心是辉瑞全球安全和风险管理部的一个分支,负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外,该中心是辉瑞全球安全和风险管理部的一个分支,负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。
联系方式
- Email:ChinaCPWTalent@Pfizer.com
- 公司地址:1 (邮编:200000)