Senior Clinical Trial Specialist
5 days ago
We are seeking a highly skilled and experienced Senior Clinical Trial Specialist to join our team at Syneos Health, Inc. This is a critical role that requires a strong understanding of clinical trial processes, regulatory affairs, and clinical operations.
Key Responsibilities- Ensure quality deliverables at the country level, following project requirements and applicable country rules, with minimal oversight from the SSU Country Manager.
- Forecast submission/approval timelines, ensure compliance, and track milestone progress in agreed-upon SSU tracking systems 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) in a timely manner, 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.
- Responsible for one or more of the following functions at the country level:
- Local Submissions Specialist - Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and PM/SSUL.
- Oversees ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country.
- Country Start-Up Advisor - Acts as Subject Matter Expert for in-country performance within the Site Start-Up.
- Local Site ID and Feasibility Support - Provides support to site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
- Local Investigator Contract and Budget Negotiator - Produces site-specific contracts from country clinical trial agreement (CTA) template.
- Line management / mentoring responsibilities - As part of developmental plans, it may be requested to provide support to management in activities such as interviewing and selection, professional development, performance management, and employee counseling and separations.
- Bachelor's Degree
- 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
- Good vendor management skills
- Strong organizational skills with proven ability to handle multiple projects
- Excellent communication, presentation, and interpersonal skills
- Quality-driven in all managed activities
- Strong negotiating skills
- Strong problem-solving skills
- Ability to mentor, lead, and motivate more junior staff
- Demonstrate an ability to provide quality feedback and guidance to peers
- Contribute to a training and Quality assurance plan within SSU and update SOPs/WI
Syneos Health, Inc. is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
We are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles.
We are an Equal Opportunity Employer and welcome applications from diverse candidates. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us.
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