Sr Clinical Research Manager-SH--某500强外资 (上海)医疗器材有限公司

 

Responsibility:
General Management:
1) People development for direct reports, perform performance review withdirect reports, discuss and approve development plan for direct reports;
2) Overview project management quality and process for direct reports; Supportdirect reports on project management and site management;
3) Review clinical research SOP and provide input on SOP revision;
4) Provide training and guidance to junior team members and business partners;
Project Management:
1) Set up and lead the project team to ensure the study is implement accordingto company policy, SOP and relative regulations.
2) Lead the project team to accomplish the proposed timeline;
3) Communicate with internal and external customers in terms of projectprogress and outstanding issues;
4) Lead the protocol design and approval process, provide scientific andfeasibility input on the protocol and other study documents design;
5) Evaluate the potential investigational sites for a specific study in termsof the quality of the investigator and the suitability of the sites;
6) Prepare study budget proposal based on fair market value. Ensure the studyis operated according to the budget.
7) Actively guide and coach CRAs in the study team;
8) Coordinate with data management, statistician and medical writer to generatethe statistical report and study report;
9) Evaluate the CRO, provide evaluation assessment to line manager;
10) Perform co-monitoring to team members.
Monitoring:
1) Initiate, monitor and close up clinical studies in compliance with studyprotocols and company’s guidance, on budget, and on time plan;
2) Document and archive all clinical trial relevant activities;
3) Verify the accuracy, completeness and legibility of the data collected inthe studies;
4) Ensure all case report forms be collected, queries be transferred betweenthe company and the investigators in a timely manner;
5) Endure all adverse events occurred in the study be reported in compliancewith study requirements;
6) Verify the trial supply to be transferred, stored and prescribedappropriately, and unused drugs to be returned or destroyed properly
Technical / Professional Knowledge Input:
1) Provide feasibility assessment and input at project planning stage based ona satisfactory level of technical and professional skill or knowledge inposition related areas;
2) Provide input on training curriculum based on current developments andtrends in areas of expertise;
3) Provide local insight on global clinical trials
Relationship Building:
1) Build up and maintain healthy relationships with internal and externalcustomers via smooth and efficient communications through the clinical studies;
2) Support the direct report to build up and maintain good relationships withstudy sites and internal customers.
Vendor Management:
1) Perform vendor selection and continuous quality and compliance tracking andevaluation
2) Perform effective and efficient vendor management to ensure the servicesvendor provided are satisfied and qualified in compliance with J&J policy,SOP and other related requirements.
Other responsibilities defined in written procedures.
Personal Requirements (include experience, knowledge, skills and education)
- Bachelor degree & above, clinical medicine would be preferred
- At least 5 years’ experience in clinical research execution, include at least2 years project management experience
- Strong people communication skill
- Good project management skill ( e.g. good planning, implementation and followup) is required
- Fluent in English speaking, reading and writing
- Good presentation skill
- Good people management skill