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Senior Clinical Manager, Catheter Care, China.

Apply Now Job ID R-347310 Date posted 09/13/2019

Job Description Summary

Job Description

Leads development and implementation of clinical programs in China.

Designs studies, formulates and conducts scientific investigations, feasibility studies, and due diligence studies related to new technologies and products. Interprets and presents results.

Provide scientific & technical guidance to the Marketing and Clinical Teams ensuring that BD demonstrates leadership by planning and delivering customer centric services in order to improve clinical practices and therefore impact patient outcomes and /or hospital profitability.  

Responsibilities:

  • Accountable for the development and execution of Clinical Trials in China and compliance to BD policies and local regulations.
  • Providing medical guidelines and recommendations for local clinical development team.
  • Collaborating with Project Manager to set targets for clinical monitoring staff and ensuring recording of trial in compliance with project goals.
  • Creating and implementing study-specific clinical monitoring tools and documents.
  • Creating and overseeing trial budget.
  • Identifying, enlisting and choosing sites, and coordinating site management activities.
  • Coordinating and supervising local clinical monitoring team.
  • Providing Clinical Research Associates with project-specific training and having regular meetings with them.
  • Recording and sharing interactions with client and acting as their representative.
  • Arranging and overseeing site visits.
  • Gathering and examining trial documents.
  • Assuring compliance SOPs and local regulations, and CFR, ICH and GCP guidelines.
  • Contributes providing expert knowledge, experience, tools, and guidance in the development of sustainable competitive advantage particularly related to local clinical practice, deep understanding of VOC, and market research, for the development and execution of strategic plans enabling MPS to achieve P&L goals.
  • Responsible for providing validated information on local clinical practices.
  • Provides expert knowledge local clinical trends, practices and unmet needs.

Qualifications:

  • RN, PhD, MD or PharmD in scientific discipline, plus previous clinical trials management experience in/with China.
  • English and Mandarin: Fluent both written and oral required.
  • Strong knowledge of CFDA and other China Medical Device and Drugs regulations and their practical implementation is required.
  • 3+ years experience as a Clinical Research Associate in/with China.
  • Knowledge of China medical device and pharmaceutical industry, terminology and practices.
  • Strong verbal and written communication skills.
  • Proficient with Microsoft Office Word, Excel and Power Point.
  • Ability to manage and prioritize workload effectively.
  • Ability and willingness to travel 30-35% of time.

#LI-TECH

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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