Clinical Operations Manager

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