J&J Family of Companies Clinical Research Manager-SH in Shanghai, China

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

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

Primary Location

China-Shanghai-Shanghai

Organization

Johnson & Johnson Medical Shanghai Ltd. (7055)

Job Function

Clinical Research non-MD

Requisition ID

1700189783W