Senior Site Activation Specialist (SAS) – Sponsor Dedicated/ Remote (US - East C
Syneos Health, Inc., Granite Heights, WI, United States
Senior Site Activation Specialist (SAS) – Sponsor Dedicated / Remote (US East Coast)
Updated:
April 24, 2026
Location:
USA-TX-Remote (Remote – U.S. East Coast)
Job ID:
25107890
We are seeking an experienced Site Activation Specialist (Senior) to support a sponsor‑dedicated FSP partnership during critical build and execution phases. This role is ideal for a strong, independent contributor who can lead site start‑up activities end‑to‑end while refining processes in a fast‑moving, evolving environment.
Overview
Lead investigative sites from selection through activation and study maintenance on global Phase I–IV trials. Own site start‑up activities, regulatory & ethics submissions, essential document management, and coordination across cross‑functional teams.
Key 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).
Manage essential document collection, review, and finalization.
Execute site activation readiness and launch.
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 key contact with Regulatory Authorities and Ethics Committees.
Ensure compliance with local regulations, safety notifications, and reporting requirements.
Identify and mitigate regulatory risks.
Act as liaison between investigational sites and cross‑functional teams (Project Leads, Site Activation Managers).
Engage sponsor stakeholders as appropriate.
Maintain local regulatory intelligence and country requirements.
Support feasibility and site identification efforts.
May act as Country Start‑Up Advisor.
Ensure all documentation is audit‑ready and filed per SOPs.
Contribute to process development and refinement.
Provide informal mentorship to less experienced team members.
Required Qualifications
3+ years of experience as a Site Activation Specialist.
Strong experience in clinical trial site start‑up, regulatory or SSU 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 with Veeva Vault in a clinical trial environment.
Ability to manage multiple studies and priorities in a fast‑paced environment.
Strong communication, organization, and problem‑solving skills.
Preferred Qualifications
FSP (Functional Service Provider) experience.
Exposure to global or multi‑country trials.
What Sets You Apart
Adaptability to fast‑paced, evolving environment.
Proactive risk identification and solution driving.
Effective collaboration across teams.
Team‑oriented focus on shared success and continuous improvement.
Benefits
Potential company car or car allowance, comprehensive medical, dental, and vision coverage, 401(k) with company match, Employee Stock Purchase Plan, commissions/bonuses based on performance, flexible paid time off (PTO) and sick time. Eligible for paid sick time per applicable laws.
EEO Statement
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, veteran status, disability, or any other legally protected status.
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Updated:
April 24, 2026
Location:
USA-TX-Remote (Remote – U.S. East Coast)
Job ID:
25107890
We are seeking an experienced Site Activation Specialist (Senior) to support a sponsor‑dedicated FSP partnership during critical build and execution phases. This role is ideal for a strong, independent contributor who can lead site start‑up activities end‑to‑end while refining processes in a fast‑moving, evolving environment.
Overview
Lead investigative sites from selection through activation and study maintenance on global Phase I–IV trials. Own site start‑up activities, regulatory & ethics submissions, essential document management, and coordination across cross‑functional teams.
Key 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).
Manage essential document collection, review, and finalization.
Execute site activation readiness and launch.
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 key contact with Regulatory Authorities and Ethics Committees.
Ensure compliance with local regulations, safety notifications, and reporting requirements.
Identify and mitigate regulatory risks.
Act as liaison between investigational sites and cross‑functional teams (Project Leads, Site Activation Managers).
Engage sponsor stakeholders as appropriate.
Maintain local regulatory intelligence and country requirements.
Support feasibility and site identification efforts.
May act as Country Start‑Up Advisor.
Ensure all documentation is audit‑ready and filed per SOPs.
Contribute to process development and refinement.
Provide informal mentorship to less experienced team members.
Required Qualifications
3+ years of experience as a Site Activation Specialist.
Strong experience in clinical trial site start‑up, regulatory or SSU 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 with Veeva Vault in a clinical trial environment.
Ability to manage multiple studies and priorities in a fast‑paced environment.
Strong communication, organization, and problem‑solving skills.
Preferred Qualifications
FSP (Functional Service Provider) experience.
Exposure to global or multi‑country trials.
What Sets You Apart
Adaptability to fast‑paced, evolving environment.
Proactive risk identification and solution driving.
Effective collaboration across teams.
Team‑oriented focus on shared success and continuous improvement.
Benefits
Potential company car or car allowance, comprehensive medical, dental, and vision coverage, 401(k) with company match, Employee Stock Purchase Plan, commissions/bonuses based on performance, flexible paid time off (PTO) and sick time. Eligible for paid sick time per applicable laws.
EEO Statement
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, veteran status, disability, or any other legally protected status.
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