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

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

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.

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

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

• 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

• 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.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.