CDP - NS
CNIBR Co. Ltd.
Shanghai, China
1天前

Job Description

1. Provides medical monitoring supports to China clinical trial delivery at country level

a. Participates in country level of protocol feasibility, interview and provide medical inputs on study design from science and medical practice

b. Provides protocol & disease training to monitors and investigators at investigator and monitoring’s meetings or scientific venues as appropriate

c. Reviews and resolves local medical issues / questions raised during the study and escalate issues to management team locally and globally when necessary

d. Ensures appropriate Adverse Events (AEs) / Serious Adverse Events (SAEs) mangement plan in place, perform local AE / SAE and Protocol Deviation (PD) review and provide medical interpretation, bring awareness of clinical trial SAEs or major PD at team level, and follow-

up with the Investigator till the issue is resolved

e. Verifies the translation of medical information in various clinical documents such as Clinical Trial Protocol (CTP), Informed Consent Form (ICF), Clinical Study Report (CSR), Investigator Brochure (IB), Site Study Summary, SAE patient narrative if needed

f. Participates and provides medical supports on GCP inspections and company’s internal audits

g. Provides medical assistance to China study team for IEC / IRB or Authority Interactions

h. Serves as internal medical expert to communicate with investigators

i. Rreviews country level or site specific ICF

2. Supports the preparation of medically related documents for a sucessful Clinical Trial Application (CTA)and New Drug Application (NDA) filing

a. Verifies the translation of medical documents for CTA and NDA filing (eg : CTP, IB, Clinical Overview, Summary of Clinical Efficacy, Summary of Clinical Safety, China CSR Appendix)

b. Coordinates scientific discussion on publications strategy implementation between integrated Clinical Trail Team (iCTT) and Chinese investigators, and ensures smooth communications, timely review and successful submission

3. Conducts literature search and key opinion leaders’ interviews

4. Maintains up-to-date knowledge on disease, local medical practice and treatment guidelines, and shares with the clinical community

5. May take on some responsibilities of the China Development Medical Manager (CDMM), under the supervision of the CDMM or China Associa.

Clinical Development Medical Director

6. Takes on special tasks assigned by the line manager

Minimum requirements

  • Medical Degree required
  • Excellent verbal and written communication skill in Chinese - and English
  • 0 - 3 years relevant industry experience
  • Basic understanding of relevant diseases, diagnoses and treatment options in China
  • Why consider Novartis?

    750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?

    We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.

    Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

    We are Novartis. Join us and help us reimagine medicine.

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