Assistant Clinical Research Manager

Job description

Principle Duties and Responsibilities (General summary, essential functions and authorities, etc.)

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 :

Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.

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