Senior Clinical Research Clinician

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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Beijing China Shanghai China

Job Description:

Senior Clinical Research Clinician

Job information:

Position:

Senior Clinical Research Clinician

Department:

Clinical Development (CD)

Report to (Job Title):

Senior Clinical Research Lead

Direct Report (Number):

Peer Position:

Other Functional Managers

General job accountability:

• Lead the clinical trials for the assigned compounds or products in China and/or globally (for some specific China R&D-driven compounds).
• Accountable for all clinical trials deliverables according to Clinical Development plan.

Principal accountability and internal and external contacts: (Please attach other paper if needed)

A. Primary responsibility

• Lead the clinical trials for the assigned compounds or products in China.
• Propose clinical study design and develop clinical study protocol based on the clinical development plan.
• Be accountable for clinical trial deliverables (e.g. Clinical study protocol clinical study reports and submission summary / HA response document). Ensure the medical and scientific sound and fully meet HA requirements for the compound registration.
• Provide clinical inputs and resolution for medical issues.
• Act as a clinical expert concerning clinical scientific issues of internal and external customers.

B. Contacts of key internal and external stakeholders

Internal

External

Cross- function teams in China R&D (e.g. RA GCO Statistics Discovery MAF DM Programmer etc.)

Investigators/KOLs

Global clinical team

Specialized medical association and other key stake holders

China Clinical leader and other relevant clinical persons

Qualification and competency requirements

• undefined
• Education /Training background:
• undefined
• Knowledge/Skills:
• Thoroughly understand and command knowledge of product and relevant diseases
• Solid knowledge of clinical development process and HA (especially CFDA) requirements
• Thoroughly understand and command GCP
• Thoroughly understand and command HCC
• Job experience:
• undefined
• undefined
• Competency:
• undefined
• Others:
• undefined

Required Skills:

Preferred Skills:

Clinical Research and Regulations Clinical Trials Clinical Trials Operations Collaboration Consulting Data Management and Informatics Drug Discovery Development Industry Analysis Innovation Leadership Market Research Regulatory Affairs Management Research Ethics Scientific Evaluation Scientific Research Stakeholder Management Tactical Planning Technical Credibility