The Clinical Research Physician (CRP) has a key role in developing the strategies and plans of clinical research leading to product registration.
This individual will be responsible and accountable for the development of best China development plan. Clinical research partners closely with regulatory affair, project management, clinical trial operation, commercial team for flawless plan and execution of registration strategy.
The CRP is responsible for preparation of the clinical/regulatory documents and acts as an in-house medical expert in close collaboration with the Clinical Operations team.
Drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high-quality clinical study protocol. We place high value on efficient, feasibility, most desirable labels, and cost effective, necessitating careful collaboration with operational experts. The clinical monitor will interpret, prepare clinical study reports, regulatory dossier, regulatory responses, and review product label. The clinical research physician will also prepare and review manuscript for publication.
Develop the content writing of clinical research related documents including clinical trial protocol, Investigator’s Brochure, clinical study report etc. to support clinical trial research and meet local registration needs.
Contribute to the preparation of the dossier and providing answers to the regulatory authorities in a timely fashion during any stages of clinical trial proceeding.
Support approval of clinical and strategic initiatives from IPCs and/or local regulatory authorities.
Work with study team to ensure safety/efficacy information adequately captured and review serious adverse events. Clinical research physician will review and approve monitoring plan/reports/data listings.
Ongoing review and develop SOPs as well as standard documentation tool kits applicable to clinical operations in China.
Ensure ICH-GCP, local regulatory and global policy compliance.
Engage scientific leaders (KOLs) and internal key stakeholders such as medical affair, and marketing and regulatory affair etc. The clinical physician will be involving in introducing development to China KOLs and seek feedback for our clinical development plan as needed.
Participate due diligence evaluation as expert for potentially new assets.