Description
Syneos Health is seeking a Site Activation Specialist I/II to join their team in Guangzhou. The successful candidate will be responsible for ensuring quality deliverables at the country level, following project requirements and applicable country rules.
Responsibilities:
- Monitor and track milestone progress in real-time, investigating and providing clear rationale for delays, and escalating issues as needed
- Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner
- Support continuous improvement of quality in all Site Start-Up (SSU) components at the country level
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements
- Prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required
- Act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues
- Provide support with site selection, contract and budget negotiations, and site activation end-to-end process at country/site level
Requirements:
- 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
- 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, problem-solving skills, and demonstrated ability to work independently as well as part of a team