SSUS II
On-site · Guangzhou, Guangdong, China
Job Summary
Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager. Manages submissions/approvals timelines, tracks milestones in real time, and investigates delays with contingency plans. Oversees basic financials (hours/tasks) per contract, ensures SOPs/WIs are followed, maintains training records, and ensures timesheet compliance. Supports continuous improvement of Site Start-Up components at the country level (submissions, essential document collection, communications to authorities). Prepares and submits Central and Local EC/RA applications and other local regulatory submissions; coordinates with PM/SAM and CSA. Acts as liaison between investigational sites and functional leads; supports site activation end-to-end at country/site level. Provides input on local legislation, SOPs/WIs, training materials, and issue resolution; may assist with data protection statements and contract templates. Requires strong project management, budgeting, vendor management, and cross-functional collaboration skills to deliver regulatory submissions and site activation in a global clinical trial context.
Required Qualifications
- Bachelor’s Degree
- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
- Ability to understand clinical protocols and associated study specifications
- Detailed understanding of clinical trial start-up processes
- Ability to manage external vendors to contract effectively
- Strong organizational skills with ability to handle multiple tasks effectively
- Strong written and verbal communication and interpersonal skills
- Ability to manage multiple project budgets with increased complexity and value
- Quality-driven in all managed activities
- Good negotiating skills
- Good problem-solving skills
- Demonstrated ability to work independently as well as part of a team
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