Clinical Project Manager 临床项目经理
煌途(北京)科技有限公司
- 公司规模:150-500人
- 公司性质:合资
- 公司行业:制药/生物工程
职位信息
- 发布日期:2018-04-02
- 工作地点:上海-浦东新区
- 工作经验:无工作经验
- 职位月薪:2-3万/月
- 职位类别:临床研究员 生物工程/生物制药
职位描述
职位信息
Lead core project teams and facilitate team’s ability to lead extended/complete project team(s). Depending on the size and scope of project(s) ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders. The PM Job duties may be performed in collaboration with a senior project manager and/or Project Director.
Provide project focussed leadership across Covance departments, offices, external vendors and clients to deliver corporate and department objectives
Proactively identify and resolve conflicts as needed
Monitor project scope, schedule and costs to ensure all remain on track per contract
Proactively utilize both quality control and risk management activities to ensure project deliverables are met in accordance to regulatory, client and Covance requirements. Create required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary
Proactively manage variance to project plans to bring the study back in line with stated project standards. Monthly metrics reports will be reported accurately and on-time to assist in maintenance of project standards
Aid in the development and maintenance of key project performance indicators for client specified metrics
Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s)
Meet financial performance targets for assigned project(s). Accountable for budget control across assigned project(s) and accurate month-to-month completion of earned value analysis, as assigned, and evaluation and management of billed time to plan to minimize write-off and capitalize on fixed price gains. Proactively identify out of scope activities and execute necessary change orders prior to out-of-scope work being done. Proactively identify project inefficiencies and address issues proactively to stay within budget.
Ensure project procurement needs are managed appropriately and per Covance SOPs
Collaborate with finance to initiate monthly invoicing as assigned
Ensure that all staff allocated to assigned project(s) adhere to professional standards and SOP and are working within the assigned allocation.
Initiate improvements to enhance the efficiency and the quality of work performed on the assigned projects
Prepare and actively participate as operational lead in internal project review meetings. Deepening on the size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and/or Project Director
Provide performance feedback to tam members to respective line managers
Present at external and/or internal meetings as required
Ensure client satisfaction
Define and manage project human resource needs and establish succession plans for key resources
Responsible for appropriate issue escalation to appropriate stakeholder(s) inclusive of CAIR and CAPA completion as required
Serve as key client contact for assigned project(s)
Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
Prepare and deliver presentations in collaboration with relevant departments for new business as required
May have line management responsibilities for training, utilization, development and performance review of assigned staff.
Perform other duties as assigned by management.
Education / Qualifications
University/college degree (life sciences preferred) or certification in a related allied health profession (e.g. nursing, medical or laboratory technology) from an appropriately accredited institution
Detailed knowledge of financial control procedures (i.e. earned value analysis)
Working knowledge of project management processes
Working knowledge of time and cost estimate development
Working knowledge of ICG guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Broad knowledge of drug development process and client needs
Experience
Minimum of five (5) years relevant clinical research experience including demonstrated skills and competency in clinical project management tasks
In lieu of the above requirements, candidates with >/= six (6) years supervisory experience in a heath care setting and five (5) years clinical research experience with at least one (1) year project management experience in the pharmaceutical or CRO industries will be considered
Experience in managing projects in a virtual environment
Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
Financial awareness and ability to actively utilize financial tracking systems
Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
Demonstrated ability to lead by example and to encourage team members to seek solutions independently
Excellent communication, planning and organizational skills
Ability to work independently
Ability to negotiate and liaise with clients on a professional manner
Ability to present to staff at all levels
Good computer skills with good working knowledge of a range of computer programs
Ability to assess technology alternatives and implications. In line with relevant functional
Lead core project teams and facilitate team’s ability to lead extended/complete project team(s). Depending on the size and scope of project(s) ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders. The PM Job duties may be performed in collaboration with a senior project manager and/or Project Director.
Provide project focussed leadership across Covance departments, offices, external vendors and clients to deliver corporate and department objectives
Proactively identify and resolve conflicts as needed
Monitor project scope, schedule and costs to ensure all remain on track per contract
Proactively utilize both quality control and risk management activities to ensure project deliverables are met in accordance to regulatory, client and Covance requirements. Create required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary
Proactively manage variance to project plans to bring the study back in line with stated project standards. Monthly metrics reports will be reported accurately and on-time to assist in maintenance of project standards
Aid in the development and maintenance of key project performance indicators for client specified metrics
Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s)
Meet financial performance targets for assigned project(s). Accountable for budget control across assigned project(s) and accurate month-to-month completion of earned value analysis, as assigned, and evaluation and management of billed time to plan to minimize write-off and capitalize on fixed price gains. Proactively identify out of scope activities and execute necessary change orders prior to out-of-scope work being done. Proactively identify project inefficiencies and address issues proactively to stay within budget.
Ensure project procurement needs are managed appropriately and per Covance SOPs
Collaborate with finance to initiate monthly invoicing as assigned
Ensure that all staff allocated to assigned project(s) adhere to professional standards and SOP and are working within the assigned allocation.
Initiate improvements to enhance the efficiency and the quality of work performed on the assigned projects
Prepare and actively participate as operational lead in internal project review meetings. Deepening on the size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and/or Project Director
Provide performance feedback to tam members to respective line managers
Present at external and/or internal meetings as required
Ensure client satisfaction
Define and manage project human resource needs and establish succession plans for key resources
Responsible for appropriate issue escalation to appropriate stakeholder(s) inclusive of CAIR and CAPA completion as required
Serve as key client contact for assigned project(s)
Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
Prepare and deliver presentations in collaboration with relevant departments for new business as required
May have line management responsibilities for training, utilization, development and performance review of assigned staff.
Perform other duties as assigned by management.
Education / Qualifications
University/college degree (life sciences preferred) or certification in a related allied health profession (e.g. nursing, medical or laboratory technology) from an appropriately accredited institution
Detailed knowledge of financial control procedures (i.e. earned value analysis)
Working knowledge of project management processes
Working knowledge of time and cost estimate development
Working knowledge of ICG guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Broad knowledge of drug development process and client needs
Experience
Minimum of five (5) years relevant clinical research experience including demonstrated skills and competency in clinical project management tasks
In lieu of the above requirements, candidates with >/= six (6) years supervisory experience in a heath care setting and five (5) years clinical research experience with at least one (1) year project management experience in the pharmaceutical or CRO industries will be considered
Experience in managing projects in a virtual environment
Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
Financial awareness and ability to actively utilize financial tracking systems
Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
Demonstrated ability to lead by example and to encourage team members to seek solutions independently
Excellent communication, planning and organizational skills
Ability to work independently
Ability to negotiate and liaise with clients on a professional manner
Ability to present to staff at all levels
Good computer skills with good working knowledge of a range of computer programs
Ability to assess technology alternatives and implications. In line with relevant functional
职能类别: 临床研究员 生物工程/生物制药
关键字: 临床监察 PM
公司介绍
Beijing Health Tech Medical Group (HT-Med) was founded since 2004. We are a comprehensive medical Operation and development organization .Assemble excellent talents of medicine, pharmacy, data management and statistical fields, offering professional services to support biotech and pharmaceutical companies at every stage of product lifecycle .
We provide Medical translation, Data Management, Statistical Analysis, Medical Writing, Regulatory Affairs, Project Evaluation and Management, Independent Audit, Training, CRA/CRC/DM dispatch. Since we established, we were developing new drugs with Chinese Academy of Medical Sciences, Peking University Health Science Center, The General Hospital of the PLA, Military Medical Sciences, etc. Has cooperated with over 90% clinical trial sites (hospital) approved by SFDA.
We developed independently EDC+CTMS by ourselves, obtained 3 patents and 2 brands. Basing on excellent IT capability, we develop Products Data Center for our clients, and created role exchange pattern between CRA and CRC, improved speed&quality of Clinical Study by the model of EDC+CRC, especially in PMS. We have been became the vendor of lots of global company (AZ, GSK, BI, Abbott, Roch, Mundipharma, QPS etc.) and some official Institution (Chinese Academy of Medical Sciences, Peking university, The general hospital of Chinese PLA, Sanming hospital, Zhejiang oncology hospital, Academy of Military Medical Sciences of the Chinese PLA etc.).
We are familiar with China SFDA policy and CDE mentality, possessing mass of expert resource and marketing support. we could cover 90% Chinese certificated clinical research hospital by lots of home-based employee in 18 cities.
公司邮箱:yanmei.wang@ht-med.com
公司网址:http://www.ht-med.com
We provide Medical translation, Data Management, Statistical Analysis, Medical Writing, Regulatory Affairs, Project Evaluation and Management, Independent Audit, Training, CRA/CRC/DM dispatch. Since we established, we were developing new drugs with Chinese Academy of Medical Sciences, Peking University Health Science Center, The General Hospital of the PLA, Military Medical Sciences, etc. Has cooperated with over 90% clinical trial sites (hospital) approved by SFDA.
We developed independently EDC+CTMS by ourselves, obtained 3 patents and 2 brands. Basing on excellent IT capability, we develop Products Data Center for our clients, and created role exchange pattern between CRA and CRC, improved speed&quality of Clinical Study by the model of EDC+CRC, especially in PMS. We have been became the vendor of lots of global company (AZ, GSK, BI, Abbott, Roch, Mundipharma, QPS etc.) and some official Institution (Chinese Academy of Medical Sciences, Peking university, The general hospital of Chinese PLA, Sanming hospital, Zhejiang oncology hospital, Academy of Military Medical Sciences of the Chinese PLA etc.).
We are familiar with China SFDA policy and CDE mentality, possessing mass of expert resource and marketing support. we could cover 90% Chinese certificated clinical research hospital by lots of home-based employee in 18 cities.
公司邮箱:yanmei.wang@ht-med.com
公司网址:http://www.ht-med.com
联系方式
- 公司网站:http://www.ht-med.com1SOPCRA2CRAsPMTMF3PM412CET-6,3GCP4
- Email:yanmei.wang@ht-med.com
- 公司地址:地址:span上海浦东新区张江高科技园区亮景路199号