
Clinical Trial Operations Specialist
1 day ago
At Syneos Health, we are dedicated to accelerating customer success by translating unique clinical, medical affairs and commercial insights into outcomes that address modern market realities.
About the Role
We are seeking a highly skilled Clinical Trial Operations Specialist to join our team. As a key member of our Site Activation department, you will be responsible for ensuring quality deliverables at the country level, following project requirements and applicable country rules with minimal oversight from the SSU Country Manager.
Responsibilities
- Forecast submission/approval timelines, ensure compliance and track milestone progress in agreed upon SSU tracking system in real time.
- Monitor financial aspects of the project and the number of hours/tasks available per contract, escalating discrepancies in a timely fashion.
- Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WI), keeping training records updated accordingly and ensuring timesheet compliance.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
Requirements
- Bachelor's Degree, preferably in a science field.
- Minimum of 3.5 years' experience as a country start-up specialist.
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
- Good understanding of clinical protocols and associated study specifications.
- Excellent understanding of clinical trial start-up processes.
- Project management experience in a fast-paced environment is an advantage.
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