商丘招聘

Responsibility:

·General Management:

-People development for direct reports, perform performance review with direct reports, discuss and approve development plan for direct reports

-Overview project management quality and process for direct reports; Support direct reports on project management and site management;

-Review clinical research SOP and provide input on SOP revision;

-Provide training and guidance to junior team members and business partners;

·Project Management:

-Set up and lead the project team to ensure the study is implemented according to company policy, SOP and relative regulations;

-Lead the project team to accomplish the proposed timeline;

-Communicate with internal and external customers in terms of project progress and outstanding issues;

-Lead the protocol design and approval process, provide scientific and feasibility input on the protocol and other study document design;

- Evaluate the potential investigational sites for a specific study in terms of the quality of the investigator and the suitability of the sites;

- Prepare study budget proposal based on fair market value. Ensure the study is operated according to the budget;

- Actively guide and coach CRAs in the study team;

- Coordinate with date management , statistician and medical writer to generate the statistical report and study report;

- Evaluate the CRO, provide evaluation assessment to line manager;

- Perform co-monitoring to team members.

·Monitoring

-Initiate, monitor and close up clinical studies in compliance with study protocols and company’s guidance , on budget, and on timeline;

-Document and archive all clinical trial relevant activities;

-Verify the accuracy, completeness and legibility of the data collected in the studies;

-Ensure all case report forms be collected, queries be transferred between the company and the investigators in a timely manner;

- Ensure all adverse events occurred in the study be reported in compliance with study requirements;

- Verify the trial medication to be transferred, stored and prescribed appropriately, and unused drugs to be returned or destroyed properly;

·Technical/ Professional Knowledge Input:

- 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;

- Provide input on training curriculum based on current developments and trends areas of expertise;

- Provide local insight on global clinical trial

·Relationship building:

- Building up and maintain healthy relationships with internal and external customers via smooth and efficient communications through the clinical studies;

-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.

Personal requirements :

- Bachelor's degree & above, clinical medicine would be preferred.

- At least 5 years’ experience in clinical research execution, including at least 2 year project management experience.

- Strong people communication skill.

- Project management skill (e.g. good planning, implementation and follow up) is required.

- Fluent in English speaking, reading and writing.

- Good organization and coordination skill.

- Good presentation skill.