Manager, Clinical Operations
昆泰企业管理(上海)有限公司
- 公司规模:500-1000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:2017-04-17
- 工作地点:广州-越秀区
- 招聘人数:若干人
- 工作经验:8-9年经验
- 语言要求:英语 熟练
- 职位月薪:2.5-3万/月
- 职位类别:生物工程/生物制药
职位描述
职位描述:
PURPOSE
Manage the human, material, system and fiscal resources to provide clinical monitoring services within a designated office, country or region. Ensure that clinical staff (CTAs, CRAs and/or CRSs) gains the necessary skills to perform their respective job responsibilities.
RESPONSIBILITIES
? Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
? Participate in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
? Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
? Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training.
? Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
? Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
? Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
? May fill in as a CRA or CRS for a defined project or to assist with milestone achievement on a temporary basis.
? May participate in clinical operations quality or process initiatives.
All responsibilities are essential to job functions unless noted as non-essential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
? Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
? Strong leadership skills
? Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
? Strong written and verbal communication skills including good command of English
? Excellent organizational and problem solving skills
? Effective time management skills and ability to manage competing priorities
? Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
? Bachelor's degree in a health care or other scientific discipline or educational equivalent; 7 yrs of clinical trials experience including 3 years experience in a leadership capacity; or equivalent combination of education, training and experience”
PHYSICAL REQUIREMENTS
? Extensive use of telephone and face-to-face communication requiring accurate perception of speech
? Extensive use of keyboard requiring repetitive motion of fingers
? Regular sitting for extended periods of time
? Regular travel, approximately 30% of work week
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PURPOSE
Manage the human, material, system and fiscal resources to provide clinical monitoring services within a designated office, country or region. Ensure that clinical staff (CTAs, CRAs and/or CRSs) gains the necessary skills to perform their respective job responsibilities.
RESPONSIBILITIES
? Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
? Participate in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
? Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
? Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training.
? Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
? Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
? Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
? May fill in as a CRA or CRS for a defined project or to assist with milestone achievement on a temporary basis.
? May participate in clinical operations quality or process initiatives.
All responsibilities are essential to job functions unless noted as non-essential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
? Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
? Strong leadership skills
? Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
? Strong written and verbal communication skills including good command of English
? Excellent organizational and problem solving skills
? Effective time management skills and ability to manage competing priorities
? Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
? Bachelor's degree in a health care or other scientific discipline or educational equivalent; 7 yrs of clinical trials experience including 3 years experience in a leadership capacity; or equivalent combination of education, training and experience”
PHYSICAL REQUIREMENTS
? Extensive use of telephone and face-to-face communication requiring accurate perception of speech
? Extensive use of keyboard requiring repetitive motion of fingers
? Regular sitting for extended periods of time
? Regular travel, approximately 30% of work week
职能类别: 生物工程/生物制药
公司介绍
QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
If that is your passion, we have a place for you.
If that is your passion, we have a place for you.
联系方式
- Email:chinacampus@iqvia.com
- 公司地址:地址:span建国门外大街光华东里8号中海广场