北京招聘

1.Lead and manage a CRA group in the Site Management team to ensure timely and cost effectively conduct of various types of clinical trials, with high quality and in accordance with ICH GCP, local regulatory requirements and the SOPs of dMed and/ or Sponsor.
2.Take CRA line manager’s responsibilities, to support the conduction of all types of clinical trials. Make sure the effective plan and management of sites in clinical trials, including monitoring and all the other trial management related activities in whole clinical trial execution process from site selection, trial preparation, initiation and conduction, study report inputs, assisting on site study summary approval, study report inputs, and up to site close-out.
3.It will be achieved through managing and developing a group of monitors with qualified and trained CRAs, through effective communications, developing and maintaining strong working relationships with relevant functional lines in dMed and sponsor representatives, as well as site people. Able to display dMed values in how the team delivers against goals and demonstrates strong personal leadership and initiative in leading monitoring functions.
4.The degree of responsibilities accorded to an Associate Manager, Manager or Sr. Manager will reflect their level of experience and contribution that they can make to the projects and clinical operations.

Main Responsibilities:
Clinical Trial Operations
1. Direct supervision and management of CRAs to ensure overall quality and compliance of CRAs, support study manager to ensure project milestones and metrics are met
2. Assign appropriate CRAs resource to studies, and provide coaching and guidance on prioritization of work activities
3. Collaborate with Sponsor and internal functional lines to improve clinical trial process in quality and compliance, ensure operational excellent for monitoring function
4. Conduct co-monitoring to provide coaching and feedback to CRAs on site management
5. Support CRAs to ensure site findings are address in a timely and appropriate manner, evaluate operational effectiveness to identify and implement best practices in site management cross sites or projects
6. Ensure the conduction of clinical trials in accordance with ICH-GCP, local Regulatory requirements and applicable standards of dMed and/or sponsor
7. Support study team to complete the feasibilities at site level, Investigators meeting, site initiation, recruitment completion and other monitoring activities, provide appropriate feedbacks to study team
8. Understand and ensure project delivery meet study management expectations
9. Partner with sponsor and related internal functional lines, provide input to support strategic decisions for optimizing site management activities affecting the conduct of clinical trials
10. Ensure an efficient interface between study management teams and monitoring team to promote teamwork, exchange information and leverage business opportunities
11. Peer with Study Managers, Quality Control & Training manager, physician and relevant staff to ensure the trial success
12. Support business planning, budgeting and proposal activities as needed
13. Contribute to continuous improvement initiatives such as process enhancement, innovative tools & methodologies development and application, productivity and work effectiveness enhancement.

Team Management
1. Recruit and develop CRAs to ensure the appropriate levels of skills, knowledge and experience to achieve clinical operation objectives
2. Ensure optimal utilization of available resources to reach productivity in accordance with benchmarks set by Clinical Operation
3. Identify training needs for responsible CRAs, contribute to training material development, provide delivery of new-hire training activities and ensure timely completion of training requirement
4. Manage CRA performance, identify gaps and implement necessary actions to bridge performance gaps and encourage continuous improvement
5. Ensure regular communication with site management lead on overall CRA capability and development
6. Develop and implement recognition program for CRAs to create engaged culture ? Lead and drive strategic decision to optimize site management activities affecting the conduction of clinical trials
7. Coach and mentor less experienced colleagues for career development; build the talent pipeline in monitoring and monitoring leadership
8. Under site management lead’s guidance, embed an ownership accountability mindset and culture in the team
9. Support site management lead in participation and representation at professional society meeting and external training events
10. Perform any reasonable duties assigned by management lead

Requirements:
1. Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); Advanced Degree in biomedical sciences (MSc, PhD, MBA) preferred
2. For Associate Manager, minimum 4 years of experience in clinical trials as CRA, Site Management (or equivalent), including no less than 1 year people management or project management experience, and present excellent performance and good potential to engage others to achieve the team goal
3. For Manager and Senior Manager, minimum 6 years of clinical trial site management experience, and over 2 years people management experience with track record of team retention and performance
4. Solid working knowledge of GCP guidelines and strong sense to regulatory requirements
5. Proficiency in Microsoft Word, Excel, PPT and familiarity with use of database as well as clinical operations related systems
6. Expertise in operational aspects of clinical drug development, solid experience in site management

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