Clinical Research Associate

1 month ago

Shanghai, Shanghai, China Novo Nordisk AS Full time

Are you passionate about driving innovation in the pharmaceutical industry? Do you want to make a meaningful impact on the lives of patients? We're seeking a skilled Clinical Research Associate to join our team at Novo Nordisk A/S.

The Role

  • As a Clinical Research Associate, you will be the primary point of contact between site staff and our company, acting as an ambassador for Novo Nordisk A/S and contributing to making us the preferred partner.
  • You will be responsible for taking leadership of site management for the selection and initiation of sites, as well as conduct and closing activities of appointed studies in compliance with local regulations, ICH-GCP, and Novo Nordisk A/S procedures and protocol requirements to ensure data quality and study subject protection.
  • You will manage the site to meet patient recruitment rate and target, delivering results that have a direct impact on the successful completion of the clinical programme.
  • You will coordinate with LTM and RTM, communicating progress and critical issues that may impair trial progress.

Requirements

  • Bachelor's degree or above in Medical Science, e.g., medical, pharmacy, nursing, etc.
  • Adequate English verbal and written skills
  • Requires a minimum of one year of clinical trial experience within the pharmaceutical industry or CRO; preferably in clinical monitoring. Other experience may also be relevant, e.g., as study staff at a clinical research site.
  • Knowledge of Good Clinical Practice (GCPs), ICH Guidelines, and local regulations, research process, and scientific knowledge as relates to clinical trial conduct.
  • Willingness to travel

About the Department

In CMRQ (Clinical Medical Regulatory and Quality), we commit to bringing our products to the Chinese market with the fastest speed and top quality, and applying the most scientific way to communicate our products' benefits to our customers. We have 6 teams in CMRQ aiming to portfolio evaluation and overall strategy; new product approval, license maintenance, product localization; clinical evidence trial operation Phase (I-IV, NIS); multiple stakeholders' engagement (HA/KOLs/investigators) and medical evidence generation/communication.

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