Senior Site Activation Specialist (SAS) - Sponsor Dedicated/ Remote (US - East Coast)

Syneos Health Careers • Full-time • Remote (United States) • $90k - $120k / year • 6m ago

Senior Site Activation Specialist (SAS) - Sponsor Dedicated/ Remote (US - East Coast)

Job Responsibilities

Senior Site Activation Specialist (SAS) - Sponsor-Dedicated
Remote - U.S. (East Coast Preferred)

Overview

We 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 Do

Site 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 Bring

Required

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.