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;
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.
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
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.
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
Sr Clinical Research Manager-SH--某500强美资医疗企业