Senior Site Activation Specialist (SAS) - Sponsor Dedicated/ Remote (US - East Coast)
Job ResponsibilitiesSenior Site Activation Specialist (SAS) - Sponsor-DedicatedRemote - U.S. (East Coast Preferred)OverviewWe are seeking an experienced Site Activation Specialist (Senior) 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.
What You'll DoSite Start-Up Execution- 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)
- Essential document collection, review, and finalization
- Site activation readiness and execution
- Ensure delivery on time, within budget, and to quality standards
Regulatory & Submission Leadership- 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
Site & Stakeholder Coordination- 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
Country-Level Ownership & Expertise- 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)
Quality & Compliance- Ensure all documentation is complete, audit-ready, and filed in the Trial Master File (TMF) per SOPs and sponsor requirements
Process & Team Contribution- Contribute to process development and refinement as the partnership evolves
- Provide guidance and informal mentorship to less experienced team members
What You BringRequired- 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
Preferred
- FSP (Functional Service Provider) experience strongly preferred
- Exposure to global or multi-country trials
What Sets You Apart- 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
Team & Environment- Build-phase partnership where execution and process development happen in parallel
- High expectations for accountability, adaptability, and collaboration
- Strong emphasis on teamwork, knowledge sharing, and continuous improvement
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a 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, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
