🧩 Site Activation Specialist II
📍 Location: Remote – Canada (CAN)
🏢 Company: Syneos Health®
🆔 Job ID: 25103330
📅 Updated: Yesterday
🔹 Category: Clinical Operations / Regulatory Affairs
🔹 Employment Type: Full-Time
🌍 About Syneos Health®
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success by combining clinical, medical, and commercial expertise.
With a presence in 110 countries and over 29,000 professionals, we partner with biopharma companies to bring innovative therapies to patients faster.
Our mission: to simplify, streamline, and innovate — making Syneos Health easier to work with and work for.
💬 Work Here Matters Everywhere.
🔗 Learn more: www.syneoshealth.com
💼 Position Summary
The Site Activation Specialist II (SAS II) is responsible for country-level start-up deliverables and regulatory submissions to support clinical trial activation.
This role ensures compliance with ICH-GCP, local regulations, and company SOPs while maintaining quality, timeliness, and accuracy throughout the Site Start-Up (SSU) process.
Working with moderate oversight from the SSU Country Manager, the SAS II serves as a critical liaison between investigational sites, regulatory authorities, and internal study teams to facilitate seamless trial initiation.
🧠 Key Responsibilities
1️⃣ Country-Level Project Execution
Ensure high-quality deliverables at the country level, aligning with project timelines and local regulatory requirements.
Track and report progress in SSU tracking systems; investigate and explain delays, propose mitigation plans, and escalate issues promptly.
Support continuous process improvement and compliance across all SSU components (submissions, document collection, ethics communication, etc.).
2️⃣ Regulatory Submissions & Documentation
Prepare and submit:
Central & Local Ethics Committee (EC) Applications
Regulatory Authority (RA) Applications
Hospital and Local Approvals, amendments, and safety notifications as required.
Manage ongoing submissions and periodic updates per country-specific rules.
Ensure all documents are uploaded to the Trial Master File (TMF) per SOP and sponsor requirements.
3️⃣ Site Activation & Liaison
Coordinate essential document collection and review site packages for activation.
Serve as a contact point for PM/SAM during start-up and facilitate communication between investigational sites and functional leads.
Oversee site activation processes end-to-end at the country or site level.
4️⃣ Country Start-Up Advisor Responsibilities
Act as Subject Matter Advisor for local site start-up and regulatory intelligence.
Maintain and update local regulatory information in the company’s central repository (EC/RA submissions, data protection notifications, import/export licenses).
Provide guidance on data protection compliance and local document adaptation (ICFs, CDAs, contracts).
Contribute to the development of local SOPs, WIs, and internal training materials on country-specific regulations.
5️⃣ Feasibility, Contracts & Budget Support
Assist in site selection and feasibility assessments to ensure optimal site performance.
Support Site Contracts Service Centre and SAM in preparing, reviewing, and negotiating clinical trial agreements (CTAs) and budgets.
Perform quality control of contracts, manage document archival, and ensure metadata capture.
🎓 Qualifications & Skills
|
Requirement Area |
Details |
|---|---|
|
Education |
Bachelor’s degree in Life Sciences, Pharmacy, or related field. |
|
Experience |
Proven experience in clinical trial start-up, regulatory submissions, and site activation (Phases II–IV). |
|
Knowledge |
Strong understanding of ICH-GCP, clinical protocols, and local country regulations. |
|
Technical Skills |
Ability to manage project tracking tools, document management systems, and budgets. |
|
Communication |
Excellent written and verbal English; strong interpersonal and negotiation skills. |
|
Attributes |
Quality-driven, organized, and able to multitask effectively; capable of working both independently and in teams. |
🌈 Why Join Syneos Health
Career growth through structured development and progression programs.
Access to technical, therapeutic, and leadership training.
Recognition through Total Rewards and peer programs.
Supportive and inclusive “Total Self” culture that values authenticity and diversity.
Collaborative teams that unite diverse perspectives and ideas globally.
⚖️ Equal Opportunity Commitment
Syneos Health is an Equal Opportunity Employer, committed to fostering a diverse, inclusive, and authentic workplace.
We comply with the Americans with Disabilities Act (ADA) and all local equal employment laws, offering reasonable accommodations when needed.
📋 Additional Information
Tasks and duties are not exhaustive and may evolve as needed.
Equivalent education or experience may be considered.
This posting is not a contractual offer of employment.
Fully compliant with EU Equality Directive and local employment legislation.
🚀 Join Syneos Health
Challenge the status quo. Accelerate innovation. Make an impact on global health.
If you’re ready to contribute to groundbreaking clinical development, apply now or join our Talent Network to explore future opportunities.
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