Sr. Manager, Clinical Research

Found in: beBee S CN - 3 weeks ago

Shanghai, China MSD Full time

Job Description

Position Overview

China Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important mission of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of assigned program(s) for developing local registration strategy, engaging key opinion leaders, developing study protocol, drafting study report, and preparing dossier for regulatory submission.

Main Responsibility

  • This individual will serve as the key interface between headquarter project development team and China development center. The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  
  • Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high quality clinical study protocol.
  • The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs and investigator meeting during study initiation phase, and review protocol deviation and answer protocol related questions during study implementation phase.
  • To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders and internal key stakeholders such as medical affair, and marketing and regulatory affair. The clinical physician will be involving in introducing new compounds in development to China scientific leaders and seek feedback for our clinical development plan as needed.
  • The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities.

Requirements

  • Master or above degree in clinical medicine (at least 5 year medical school graduates)
  • Deep understanding of China regulatory environment and clinical development procedure.
  • Previous experience of clinical research/clinical development is highly desirable,
  • Be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful. 
  • have a strong leadership, excellent written and oral communication skills, and project management skills.
  • Strong capability of work prioritization and deliver results with parallel multiple tasks.
  • Excellent language skills in both English and Chinese (fluent in verbal and written).
  • The position may require the flexibility to work outside of the area of primary medical specialization.   

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):


Requisition ID:R289637

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