Syneos Health
SiteActivationSpecialistIIBeijing
“Site Activation Specialist II - Beijing at Syneos Health. Skills: Site activation, Regulatory submissions, Document management. Provide quality on deliverables at country level. Follow project requirements and country rules”
Industry & Context.
Utilize problem-solving techniques effectively
What They're Looking For.
Must Have
Associate degree or equivalent combination of education and training, Good understanding of clinical trial process across Phases II-IV and ICH GCP, Ability to interact effectively and appropriately with investigative site personnel, Good organizational skills and good attention to detail, Proven ability to handle multiple tasks effectively, Ability to take direction from multiple individuals and set priorities accordingly, Ability to effectively communicate across multiple function groups (clinical team, PM, Director), Demonstrated ability to work independently, as well as part of a team, Utilize problem-solving techniques effectively, Quality-driven in all managed activities, Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions, Computer skills, including Word, Excel, PowerPoint, Publisher
What You'll Do.
Provide quality on deliverables at country level
Follow project requirements and country rules
Work within forecasted submission/approval timelines
Track milestone progress in SSU tracking system
Provide rationale for delays
Assist with contingency plans
Escalate issues as identified
Monitor basic financial aspects of project
Escalate financial discrepancies
Review and comply with SOPs and WIs
Keep training records updated
Ensure timesheet compliance
Submit documents to Trial Master File (TMF)
Follow project direction from CSA and SAL
Serve as point of contact for SAL/PM
Compile and review essential document packages
Involved in essential document collection
Prepare and submit Central EC Applications
Prepare and submit Local EC Applications
Prepare and submit RA Applications
Prepare and submit other local regulatory authorities or hospital approval submissions
Prepare ongoing submissions
and periodic notifications
Act as liaison between investigational sites and functional leads
Oversee site activation end to end process
Provide support with site selection
Ensure appropriate sites are selected for studies
Support SAL to agree on country template contract and budget
Assist in producing site-specific contracts
Assist in negotiations of budget and contract
Assist with quality control
Arrange execution of CTAs
Archival of documents into repositories
How You'll Work.
Team & Collaboration
Interact effectively and appropriately with investigative site personnel; Take direction from multiple individuals; Effectively communicate across multiple function groups (clinical team, PM, Director); Work as part of a team; Act as liaison and facilitator between investigational sites and functional leads
Communication Scope
Ability to effectively communicate across multiple function groups
Process & Methodology
Process management, Cross-functional coordination, Vendor/stakeholder management, Operational metrics, Resource planning, Continuous improvement
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