ASSOCIATE PRECLINICAL RESEARCH MANAGER

JOB SUMMARY The individual will serve as QC lead and study coordinator in preclinical research, and may serve as study director for evaluation studies.
The individual will responsible for the quality related work in preclinical research function to make sure the preclinical work meet all applicable quality requirement.
This individual also act as study coordinator contribut ing to/support the design, execution, analysis and interpretation of preclinical studies to understand the safety and efficacy of products.
DUTIES & RESPONSIBILITIES Under limited supervision and in accordance with all applicable China and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position.
Ø Act as QC lead to establish and maintain quality system in preclinical function, responsible for all the quality related work in preclinical research.
Ø Act as study coordinator in support of a Sponsor Representative/Study Director.
Is responsible for collaborating on Protocol development and approval.
Is accountable for assisting in study requests, documentation preparation, and communication with study director to ensure they understand the study requirement.
Is responsible for assisting communication with Study Director for study deviations and support in follow up and collect related documentation for Study Director assessment.
Is responsible for study execution oversight and study data collection as needed.
Is responsible for collaborating on the Summary Report development and approval as needed.
Serves as the single point of contact with the Sponsor Representative/Study Director to communicate timelines, issues, and milestones regarding study conduct.
Quality control.
support in or lead data review and quality compliance.
Assist in JNJ QA audit as needed.
Ø May fulfill role as Study Director for Service and Evaluation studies.
Is accountable and responsible for Evaluation Proposal development and approval.
Is accountable for procedural data collection, verification, and evaluation.
Is accountable for the quality and compliance of the assigned studies.
Is accountable and responsible for the Summary Report development and approval.
Preclinical Study Execution Ø Responsible for communicating business related issues or opportunities to next management level.
Ø Responsible for ensuring compliance with all country, local and Company regulations, policies, and procedure.
Ø Performs other duties assigned as needed Qualifications Requirements.
Master’s degree preferred in veterinary medicine, medical, biological sciences, biomedical engineering, and related major.
Bachelor’s degree required.
At minimum 1 year experience for Master’s degree and 3- year experience for Bachelor’s degree in preclinical research experience in a medical device or pharmaceutical setting.
5 year above G X P background is required.
² Experience with large animal preclinical studies as study coordinator or above is preferred.
² General knowledge of Preclinical Research is required.
Knowledge of NMPA regulations related to preclinical research is highly desired.
² General knowledge of animal and human anatomy and physiology, surgical principles & theory, as well as biological systems is highly desired.
² Good communication skills to facilitate smoothly work cross functionally.
² Good English communication (both written and verbal) skill is required.