General Summary The overall purpose of the position is specified as follows, – People management and development for direct reports，includes internal and contract CRA team – Provide coaching, training and guidance to direct reports, to ensure: Clinical trial to be conducted in compliance with GCP/SOPs, local regulatory regulations and protocols, any adverse events known from clinical trials to be reported properly project execution according to timeline and budget Develop and maintain working relationships with others requiring interaction and mutual support – Vender (CRO) management
Responsibility General Management (if applicable): 1) People development for direct reports, perform performance review with direct reports, discuss and approve development plan for direct reports; 2) Overview site management quality and process for direct reports; Support direct reports on site management; 3) Review clinical research SOP and provide input on SOP revision, if applicable; 4) Provide training and guidance to junior team members and business partners; Project Management: 1) Evaluate the potential investigational sites for a specific study in terms of the quality of the investigator and the suitability of the sites, if applicable; 2) Actively guide and coach CRAs in the study team; 3) Evaluate the CRO, provide evaluation assessment to line manager, if applicable; 4) Perform co-monitoring to team members. Monitoring (if applicable): 1) Initiate, monitor and close clinical studies in compliance with study protocols 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 in the studies; 4) Ensure all case report forms be collected, queries be transferred between the company and the investigators in a timely manner; 5) Ensure all adverse events occurred in the study be reported in compliance with study requirements; 6) Verify the trial supply to be transferred, stored and prescribed appropriately, and unused investigational products to be returned or destroyed properly Technical / Professional Knowledge Input: 1) Provide feasibility assessment and input at project planning stage based on a satisfactory level of technical and professional skill or knowledge in position related areas, if applicable; 2) Provide input on training curriculum based on current developments and trends in areas of expertise. 3) Provide local insight on global clinical trials, if applicable Relationship Building: 1) Build up and maintain healthy relationships with internal and external customers via smooth and efficient communications through the clinical studies 2) Support the direct report to build up and maintain good relationships with study sites and internal customers, if applicable. Vendor Management: 1) Perform vendor selection and continuous quality and compliance tracking and evaluation, if applicable 2) Perform effective and efficient vendor management to ensure the services vendor provided are satisfied and qualified in compliance with J&J policy, SOP and other related requirements. Other responsibilities defined in written procedures.
Qualifications: – Bachelor's degree & above, clinical medicine would be preferred – At least 5 years’ experience in clinical research execution – Strong people communication skill – Good project management skill (e.g. good planning, implementation and follow up) is preferred – Fluent in English speaking, reading and writing. – Good presentation skill – Good people management skill