Director, Quality Risk Management and training

Basic qualifications:

1.Minimum bachelor degree in clinical medicine or Life/Biological Sciences

2.Previous experience in clinical medicine, pharmaceutical and services industry is required

3.Minimum of 10 years experience in clinical research

4.Good command of English (written and spoken)

5.Knowledge of PC (WORD, EXCEL, POWERPOINT)

6.Good Presentation and facilitation skills

7.Interpersonal communication skill and effective communication skill for a broad range of audiences

8.Team player

9.Quick learning

10.Ability to mentor and pass on skills to junior members of the team

11.Experience of working as a line manager in clinical research area for at least 6 years

12.Experience of working as a line manager in clinical research quality area for at least 2 years

13.Experience working as a site monitor

14.Focus on detail

15.MSc or PhD

16.Experience working as a study manager

17.Experience working as a trainer

18.Experience working as an auditor

Preferred qualifications:

  • Flexible Thinking: Systematically evaluating the advantages and disadvantages of several realistic alternative solutions to issues. Creating an overarching strategy as a result of this analysis, which maximizes the benefits and minimizes the risks of the original options
  • Continuous improvement: Establishing a series of measurable improvement processes. Adding value to internal and external customers through the ongoing setting and tracking of stretching performance improvement measures. Giving ongoing feedback to raise collective performance
  • Customer Driven: Taking an initiative (a clearly interconnected set of activities) designed to raise the 'value added' to customers. These activities will have a wider or longer-term effect than a specific action designed to address a particular customer issue or problem
  • Enable and drive change: Enhancing the scope for initiative by reducing barriers to the performance of self or others. Ensuring the implementation of longer-term plans or delivery of large-scale projects
  • Building Relationships: Testing and validating own understanding of the feelings and beliefs of others by paraphrasing, summarizing and clarifying. Being open with own views and feelings and encouraging others to do the same
  • Developing people: Taking personal responsibility for supporting and developing others by acting as a coach or mentor. Allocating important projects and challenging responsibilities to others for the purpose of their development

Details:

1.Responsible for Identifying, leading and implementing China Medical quality improvement strategies to ensure clinical trials conducted according to GCP, local regulation and SOP requirements

2.Provide consultancy to China Medical team on clinical quality issues and do root cause analysis to support study/department level CAPA development and implementation

3.Influence and collaborate with many internal counterparts in China Medical, RD Shanghai, PCPS, to ensure sufficient support is obtained in training, quality control and risk management

4.Responsible for Setting and Leading China Medical Clinical Operation overall risk management & compliance framework and strategy, and alignment with global PCPS, Safety and TAs

5.Responsible for quality and compliance learning sharing timely among functions for continuous improvement

6.Responsible for leading global initiative implementation in China Medical and act as global initiatives ambassador

7.Being primarily contact person of China Medical Clinical Operation to work with R&D shanghai site compliance head and PCPS quality risk management team, to ensure China Medical Clinical Operation risk management align with corporate level

8.Act as representative from China Medical to attend and contribute global risk management network

9.Work with Line Manager to establish a highly competitive risk based quality management team to ensure all activities in China Medical conducted to quality with full compliance

  • LI

Contact information:

You may apply for this position online by selecting the Apply now button.

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