Clinical Operation Manager临床试验经理
上海唯讯人力资源有限公司
- 公司规模：少于50人
- 公司性质：民营公司
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2013-11-16
- 工作地点：上海
- 招聘人数：若干
- 职位类别：生物工程/生物制药
职位描述
Overall Job Purpose/Function:
？ To manage all aspect of assigned clinical studies, to ensure that the clinical trials are conducted to meet quality standards, SOP’s and GCP, to ensure the clinical trials are in line with the timelines, be responsible for clinical trial conduct and progress in terms of allocating and monitoring requirements, CRA’s workload and complexity, to conduct co-monitoring activities and report on study progress and quality, to ensure clinical team members are appropriately trained.
Principal Accountabilities and Responsibilities:
？ Plans and manages clinical operations for assigned clinical project(s) including timelines, budgets, personnel resources, investigational sites, vendors and key project deliverables;
？ Lead the investigators meeting, including plan, convene, run and present at investigator meeting.
？ Lead protocol training meetings and support the sites’ initiation.
？ Lead and manage the line functions to ensure all trial deliverables are met according to timelines,budget, quality standards and operational procedures.
？ Work with study team to determine patient recruitment strategies and operational feasibility.
？ Authors and refines clinical operations plan and study monitoring plans
？ In collaboration with the sponsor, lead the clinical trial data ongoing medical review, final analysis including the development of clinical trial reports.
？ Manages, mentors and provides professional development guidance to assigned clinical operations staff members
？ Supervises clinical operation staff with assigned direct reports and provides mentoring as required.
？ Ensures that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented by assigned staff.
？ Recommends course of action on management/human resources matters, including career Manages, mentors and provides professional development guidance to assigned clinical operations staff members
？ Supervises clinical operation staff with assigned direct reports and provides mentoring as required.
？ Ensures that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented by assigned staff.
？ Recommends course of action on management/human resources matters, including career development, promotion, transfers.
？ Hiring, terminations, professional development, performance appraisals, and employee counseling.
？ Identifies ongoing training and development needs of assigned staff.
Requirements for position:
？ Bachelor or above degree in Medicine / life science/healthcare.
？ 5 years of experience in the Clinical Research of CRO or pharmaceutical industry .
？ 2-3 years of experience in direct people management
？ Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) required.
？ Strong communication, organizational and interpersonal skills
？ To manage all aspect of assigned clinical studies, to ensure that the clinical trials are conducted to meet quality standards, SOP’s and GCP, to ensure the clinical trials are in line with the timelines, be responsible for clinical trial conduct and progress in terms of allocating and monitoring requirements, CRA’s workload and complexity, to conduct co-monitoring activities and report on study progress and quality, to ensure clinical team members are appropriately trained.
Principal Accountabilities and Responsibilities:
？ Plans and manages clinical operations for assigned clinical project(s) including timelines, budgets, personnel resources, investigational sites, vendors and key project deliverables;
？ Lead the investigators meeting, including plan, convene, run and present at investigator meeting.
？ Lead protocol training meetings and support the sites’ initiation.
？ Lead and manage the line functions to ensure all trial deliverables are met according to timelines,budget, quality standards and operational procedures.
？ Work with study team to determine patient recruitment strategies and operational feasibility.
？ Authors and refines clinical operations plan and study monitoring plans
？ In collaboration with the sponsor, lead the clinical trial data ongoing medical review, final analysis including the development of clinical trial reports.
？ Manages, mentors and provides professional development guidance to assigned clinical operations staff members
？ Supervises clinical operation staff with assigned direct reports and provides mentoring as required.
？ Ensures that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented by assigned staff.
？ Recommends course of action on management/human resources matters, including career Manages, mentors and provides professional development guidance to assigned clinical operations staff members
？ Supervises clinical operation staff with assigned direct reports and provides mentoring as required.
？ Ensures that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented by assigned staff.
？ Recommends course of action on management/human resources matters, including career development, promotion, transfers.
？ Hiring, terminations, professional development, performance appraisals, and employee counseling.
？ Identifies ongoing training and development needs of assigned staff.
Requirements for position:
？ Bachelor or above degree in Medicine / life science/healthcare.
？ 5 years of experience in the Clinical Research of CRO or pharmaceutical industry .
？ 2-3 years of experience in direct people management
？ Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) required.
？ Strong communication, organizational and interpersonal skills
公司介绍
1. Company Profile
Combined by a group of Human Resource professionals who have sound experiences in top global corporations. Vision HR positions itself as the human resources solution provider for all human resource needs. We build your success in business by building your workforce. We will work with your different operational divisions as well as with the HR department to better leverage pools of talent and add value to your organization.
2．Service Philosophy
Vision HR guarantees to provide a specialized and efficient service through good communication to clients, multi-understanding of the job description and the candidate's information, and flawless operation of the local labor law issues.
The key is find right person for right position is our service philosophy of being successful. No matter it is in the past, now, or in future, all of us will offer service of giving customer's satisfied service.
3. Our Goal
To be a trusted advisor to our clients
Combined by a group of Human Resource professionals who have sound experiences in top global corporations. Vision HR positions itself as the human resources solution provider for all human resource needs. We build your success in business by building your workforce. We will work with your different operational divisions as well as with the HR department to better leverage pools of talent and add value to your organization.
2．Service Philosophy
Vision HR guarantees to provide a specialized and efficient service through good communication to clients, multi-understanding of the job description and the candidate's information, and flawless operation of the local labor law issues.
The key is find right person for right position is our service philosophy of being successful. No matter it is in the past, now, or in future, all of us will offer service of giving customer's satisfied service.
3. Our Goal
To be a trusted advisor to our clients