Clinical Research Manager-SH

Job description

主要工作职责（基本概况，主要功能，权限等）

General Summary （基本概况） The overall purpose of the position is specified as follows,

· People management and development for direct reports, if applicable
· Provide coaching, training and guidance to direct reports, if applicable
· Ensure clinical trial to be conducted in compliance with GCP/SOPs, local regulatory regulations and protocols
· Ensure any adverse events known from clinical trials to be reported properly
· Develop and review project timeline and budget
· Ensure project execution according to timeline and budget
· Develop and maintain working relationships with others requiring interaction and mutual support
· Vender (CRO) management

Responsibility ( 工作职责 )
· General Management ( if applicable):
· 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;
· Coordinate Medical Affairs to the protocol design and approval process, provide scientific and feasibility input on the protocol and other study documents 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 data management, statistician and medical writer to generate the statistical report and study report, if applicable;
· Evaluate the CRO, provide evaluation assessment to line manager, if applicable;
· Perform co-monitoring to team members.
· Monitoring ( if applicable):
· Initiate, monitor and close up clinical studies in compliance with study protocols and company's guidance, on budget, and on time plan;
· 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 supply to be transferred, stored and prescribed appropriately, and unused investigational products 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 in areas of expertise.
· Provide local insight on global clinical trials
· Relationship Building:
· Build up and maintain healthy relationships with internal and external customers via smooth and efficient communications through the clinical studies
· Support the direct report to build up and maintain good relationships with study sites and internal customers, if applicable.
· Vendor Management:
· Perform vendor selection and continuous quality and compliance tracking and evaluation
· 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. （流程中规定的其它职责）

Principle Relations （ inside ＆ outside company ）主要工作关系 ( 公司内部和外部 )
· Clinical research team in China, regional, global and source companies;
· Medical affairs team in China, regional, global and source companies
· Regulatory affairs team in China, regional, global and source companies
· Quality assurance team in China, regional, global and source companies
· Clinical Quality Control/Assurance team in China, regional, global and source companies
· Business team, incl. marketing, and leadership team;
· HR department, if applicable
· Finance department
· Health Care Compliance department
· Law department
· Clinical research organizations, global, regional and local
· Key opinion leaders and investigators
· CFDA officials and technical reviewers

Desired profile

Qualifications :

基本任职资格（包括教育背景和 / 或知识和 / 或培训和 / 或相关工作经验）

Personal Requirements ( include experience, knowledge ， skills and education)

个人背景要求 （包括经验，知识，技能和教育背景）
·  Bachelor's degree & above, clinical medicine would be preferred
·  At least 5 years' experience in clinical research execution, including at least 2 years project management experience
·  Strong people communication skill
·  Good project management skill (e.g. good planning, implementation and follow up) is required
·  Fluent in English speaking, reading and writing.
·  Good presentation skill
·  Good people management skill, if applicable

Required Competencies 胜任能力要求 (Level 1-4, see Appendix A)
·  Clinical trial expertise 4
·  Statistics & data analysis 2
·  Regulatory insight 3
·  Disease area knowledge 3
·  Product knowledge 2
·  Scientific presentation & publication 2
·  Customer & market insight 3
·  Managing customer & internal partners 3
·  Cultural diversity 3
·  Project Management 3