CRA

An international biopharmaceutical company is seeking to recruit a CRA to one of their Chinese offices. This organisation is known for its work in rapidly developing innovative medicines through global collaborations within Research and Development. This is an exciting opportunity to work with a leading pharmaceutical company to develop and prepare clinical trial plans.

Job Responsibilities:

• Overseeing the customer complaints regulatory reporting process (timely submissions, timely closure, health authority requests etc.).
• Ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions.
• Evaluating all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
• Setting up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service and Technical Services.
• Escalating critical issues for proper disposition as necessary.
• Receiving technical guidance on complex problems, but independently determines and develops approaches and solutions. Work is expected to result in the development of new or improved techniques or procedures
• Ensuring compliance with the company's Quality System policies and procedures, as well as applicable external requirements and standards, including FDA (21 CFR), ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, , Health & Safety Practices, and other applicable standards as pertaining to medical devices.
• Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Supporting Product Analysis Evaluation if required.

Skills and Requirements:

• Bachelor's degree or above in Medical, Pharmacy, or related areas.
• Extensive experience in all aspects of clinical trial planning and start up (including budget and resource planning), and in executing the complete range of clinical trial activities, from start up through final trial report.
• Proven track record of having successfully led one or more multinational clinical trials.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Tom Tan at +86 21 51694101 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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