Overview
SSU Jobs in Beijing, Beijing, China at Translatio (Shanghai) Trading & Consulting Co., Ltd
Title: SSU
Company: Translatio (Shanghai) Trading & Consulting Co., Ltd
Location: Beijing, Beijing, China
该职位来源于猎聘 Key Responsibilities：
- Providing quality on deliverables at the country level and follows project requirements and applicable country rules.
- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified.
- Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
- Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements. Preferred Experiences and Skills：
- Minimum of 2 years industry experience and/or a minimum of 1.5year experiences working in a SSU department, or clinical trial environment or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
- 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. Good negotiating skills and problem-solving skills.
- Quality-driven in all managed activities.
- Demonstrated ability to work independently as well as part of a team
