Job Code: CNCD01
Position: Project Manager
Department: Clinical Development
Reports to: Director, Clinical Operation
Location: Taicang Office / Remote, China
The Clinical Project Manager is responsible for managing the clinical study in accordance with ICH-GCP, applicable legal/regulatory requirements and CONNECT’s policies and Standard Operating Procedures and ensure clinical trials conducted within defined budgets and timelines.
- Plans and executes study operation activities to ensure the effective delivery of clinical studies by collaborating with cross-functional teams, vendors and study sites.
- Proactively plan and implement actions to improve study performance and quality.
- Manage suitable third parties for out-sourced services (such as clinical research organization, central laboratories, data management, statistical analysis) necessary for the preparation, initiation, operation and closure of clinical trial to ensure timely deliverables.
- Ensure clinical trials in compliance with Good Clinical Practice (GCP) and ICH-GCP, CONNECT’s SOPs and other relevant clinical research guidelines by implementing quality control activities.
- Ensure the study cost within budget and in a reasonable way.
- Develop trial mitigation plans as necessary.
- Anticipate, manage, and escalate issues as appropriate.
Key Performance Indicators:
- Delivery of clinical studies as planned timeline and milestone
- Quality and compliance management
- Budget management and budget control with ±5%
- Bachelor’s degree or master’s degree in life sciences
- At least 5 years in clinical operations.
- At least 2 years of experience in clinical project management
Skills and Attributes:
- Proficiency in computer skills
- Availability to travel according to project requirement
- Strong written and verbal communication skills
- Fluent in English and solid writing skills