CPM/Snr CPM-Late phase(Shanghai/Beijing)
昆泰医药发展(上海)有限公司
- 公司规模:150-500人
- 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:2015-06-13
- 工作地点:上海
- 招聘人数:1
- 工作经验:8-9年
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:面议
- 职位类别:生物工程/生物制药
职位描述
PURPOSE
Manage the execution of the assigned medium to large multi regionally-based clinical study(ies) per Contract, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed to the Sponsor’s satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices.
RESPONSIBILITIES
? Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects.
? Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
? Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to.
? Report on team performance against contract, customer expectations, and project baselines to management.
? Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate clinical risk.
? Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
? Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
? Provide input for the development of proposals for new work and project budgets.
? Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. Mentor less experienced CPMs.
? Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.
? Prepare and present project information at internal and external meetings.
? Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff.
? Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plans
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
? In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
? In depth therapeutic and protocol knowledge
? Strong communication and interpersonal skills, including good command of English language
? Strong organizational and problem solving skills
? Demonstrated ability to deliver results to the appropriate quality and timeline metrics
? Good team leadership skills
? Effective mentoring and training skills
? Excellent customer service skills
JOB DESCRIPTION
Page 2
? Good judgment
? Effective presentation skills
? Ability to manage competing priorities
? Strong software and computer skills, including MS Office applications
? Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field and 7 years’ clinical research experience including 4 years’ project management experience and experience in clinical operations; or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
? Extensive use of keyboard requiring repetitive motion of fingers.
? Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
? Regular sitting for extended periods of time.
? May require occasional travel.
Manage the execution of the assigned medium to large multi regionally-based clinical study(ies) per Contract, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed to the Sponsor’s satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices.
RESPONSIBILITIES
? Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects.
? Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
? Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to.
? Report on team performance against contract, customer expectations, and project baselines to management.
? Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate clinical risk.
? Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
? Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
? Provide input for the development of proposals for new work and project budgets.
? Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. Mentor less experienced CPMs.
? Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.
? Prepare and present project information at internal and external meetings.
? Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff.
? Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plans
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
? In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
? In depth therapeutic and protocol knowledge
? Strong communication and interpersonal skills, including good command of English language
? Strong organizational and problem solving skills
? Demonstrated ability to deliver results to the appropriate quality and timeline metrics
? Good team leadership skills
? Effective mentoring and training skills
? Excellent customer service skills
JOB DESCRIPTION
Page 2
? Good judgment
? Effective presentation skills
? Ability to manage competing priorities
? Strong software and computer skills, including MS Office applications
? Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field and 7 years’ clinical research experience including 4 years’ project management experience and experience in clinical operations; or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
? Extensive use of keyboard requiring repetitive motion of fingers.
? Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
? Regular sitting for extended periods of time.
? May require occasional travel.
公司介绍
ABOUT THE COMPANY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY