- Manages study operational plan&CRO,GCP,ICH
- Manager,Develops and manages comprehensive study
- Proactively identifies&resolves clinical issues
Title: Clinical Operations Manager
Location: Guangzhou, China
Our client is a major Pharma-Medical Company, they are hiring a Clinical Operations Manager for their team.
- 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.
- 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