About The Position
Syneos Health is seeking an experienced Senior Site Activation Specialist (SAS) to support a sponsor-dedicated FSP partnership during a critical build and execution phase. This role is ideal for a strong, independent contributor who can lead site start-up activities end-to-end, while also helping refine processes in a fast-moving, evolving environment. You will play a key role in bringing investigative sites from selection through activation and into study maintenance, with meaningful ownership and visibility across global trials.
Requirements
- 3+ years of prior experience as a Site Activation Specialist (SAS)
- Strong experience in clinical trial site start-up, regulatory, or SSU-related functions
- Demonstrated ability to independently manage end-to-end start-up activities
- Solid understanding of ICH-GCP, regulatory pathways, and clinical trial processes (Phases I–IV)
- Hands-on experience with regulatory/ethics submissions and essential document management
- Experience navigating and utilizing Veeva Vault in a clinical trial environment
- Proven ability to manage multiple studies and priorities in a fast-paced environment
- Strong communication, organization, and problem-solving skills
Nice To Haves
- FSP (Functional Service Provider) experience strongly preferred
- Exposure to global or multi-country trials
- Able to quickly adapt and stay effective in a fast-paced, evolving environment
- Proactive in identifying risks and driving solutions
- Confident communicator who collaborates effectively across teams
- Team-oriented, with a focus on shared success and continuous improvement
Responsibilities
- Lead country-level activities that drive site start-up across Phase I–IV trials
- Own or support: Regulatory and ethics submissions (Central/Local EC, Regulatory Authorities)
- Own or support: Essential document collection, review, and finalization
- Own or support: Site activation readiness and execution
- Ensure delivery on time, within budget, and to quality standards
- Prepare and submit EC/RA applications and manage ongoing submissions, amendments, and notifications
- Serve as a key contact with Regulatory Authorities and Ethics Committees, as needed
- Ensure compliance with local regulations, including safety notifications and reporting requirements
- Identify and escalate regulatory risks and support resolution strategies
- Act as a liaison between investigational sites and cross-functional teams
- Partner closely with Project Leads (PLs) and Site Activation Managers (SAMs) to execute start-up plans
- Engage with sponsor stakeholders as appropriate to support delivery and issue resolution
- Provide and maintain local regulatory intelligence and country requirements
- Support feasibility and site identification efforts
- May act as a Country Start-Up Advisor (CSA), providing subject matter expertise on local start-up and regulatory processes
- Contribute to country-level planning through site activation and First Patient In (FPI)
- Ensure all documentation is complete, audit-ready, and filed in the Trial Master File (TMF) per SOPs and sponsor requirements
- Contribute to process development and refinement as the partnership evolves
- Provide guidance and informal mentorship to less experienced team members
Benefits
- company car or car allowance
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- flexible paid time off (PTO) and sick time
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
