Job Highlights

  • Manages study operational plan&CRO,GCP,ICH
  • Manager,Develops and manages comprehensive study
  • Proactively identifies&resolves clinical issues

Job Description

Title:             Clinical Operations Manager

Location:      Guangzhou, China

Background:          

Our client is a major Pharma-Medical Company, they are hiring a Clinical Operations Manager for their team.

Responsibilities:

  • Manages study operational plan and CRO, ensures completion of study deliverables.
  • Proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required.
  • Develops and manages comprehensive study timelines and metrics
  • Contributes to the development of SOPs, clinical development plans, and other company initiatives as required.
  • Prepares and presents project debriefings, as required; plans, executes, and leads study-specific meetings.
  • Participates in site monitoring visits as appropriate.
  • Uses operational and therapeutic expertise to optimize trial design and execution.
  • Works with the study team to design clinical trial protocols consistent with the clinical development plan and ensures appropriate patient recruitment, detection of data trends.
  • Program management responsibility, overseeing clinical studies, with responsibility for the coordination of resources, timelines, and budgets.

Requirements:

  • BSc or MSc in life sciences, medical sciences, nursing, or equivalent education
  • 5 years of experience in clinical operations in CRO or pharmaceutical/biotech company (specifically in China)
  • Through understanding and knowledge of GCP, ICH guidelines and regulatory requirements
  • Strong clinical study management skills and vendor management experience
  • Detailed understanding of clinical protocol design and implementation in drug development
  • Excellent communication, and organizational skills, along with problem solving, conflict resolution, leadership and team building skills. 
  • Excellent document preparation skills, writing and reviewing of study documents
  • Written, spoken  and reading level must be excellent in  English

Work Benefits/ Work Environment:

  • Western and friendly company culture.
  • Great Career progression.
  • Great MPF Pension Scheme

Harbridge Partners Limited
Employment Agency Licence:  68770

Job Functions: Biomedical / Life Science / Pharma
Job Type: Full Time Permanent
Years of Experience: 5 Years

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