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1.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.
2.Participate in the selection and on-boarding process for new clinical staff by conducting candidate review and participating in the interviewing process.Conduct on-boarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
3.Ensure that staffs have 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.
4.Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training.
5.Manage the quality of assigned staff''s clinical work through regular review and evaluation of work product.
6.Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
7.Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
8.May act as a CRA or CTL for a defined project or to assist with milestone achievement.
9.May participate in clinical operations quality or process initiatives.
1.Bachelors or Master with a strong clinical background;
2.Minimum 4-5 years experience in clinical research in a CRO or pharmaceutical space WITH at least 1-2 years project management experience;
3.Knowledge of medical terminology and clinical patient management;
4.Knowledge of ICH -GCP and local regulations regarding clinical studies and the conduct of such studies;
5.Ability to understand and present relevant clinical data;
6.Excellent organizational,communication,and interpersonal skills and ability to work independently and work within a matrix team environment required;
7.Advanced computer knowledge including experience with MS Office software;
8.Strong verbal and written communication skills in both English and Chinese languages;
9.Effective time management skills and ability to manage competing priorities;
10.Ability to establish and maintain effective working relationships with co-workers,managers and clients
11.Ability to travel as and when required.
Quintiles Transnational Corp. helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Quintiles helps its customers compress the time it takes to bring a drug from discovery through regulatory approval; accelerate the launch of products to peak sales, build effective sales forces and manage product portfolios more efficiently; and achieve strategic and financial objectives by offering tailored alternatives to traditional fee-for-service product development and commercial services agreements. Headquartered near Research Triangle Park, North Carolina, Quintiles was founded in 1982 and has more than 16,000 employees and offices in over 50 countries. Quintiles Medical Development (Shanghai) Co., Ltd. is a wholly owned subsidiary of Quintiles Transnational Corp. Due to the rapid expansion of our business in China, we are seeking qualified candidates for the positions.
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