Site Activation Specialist II – Syneos Health is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. The role is focused on site start‑up and regulatory submissions at the country level, ensuring quality and compliance throughout the activation process.

Why Syneos Health

• Passionate about developing people, offering career development, training, and recognition.
• Committed to a Total Self culture where employees can authentically be themselves.
• Dedicated to building a workplace where diversity of thought, culture, and perspective is valued.

Job Responsibilities

• Ensure quality deliverables at the country level, track milestones in the tracking system, and investigate delays, providing rationale and contingency plans.
• Monitor basic financial aspects of the project, escalating discrepancies promptly.
• Review and comply with SOPs and Work Instructions, maintain training records, and ensure timesheet compliance.
• Support continuous improvement of quality in all Site Start‑Up components, including essential document collection and communication with Competent Authorities and Ethics Committees.
• Submit and manage local and central regulatory applications, ensuring compliance with Company SOPs and sponsor requirements.
• Act as liaison between investigational sites and functional leads, overseeing site activation end to end.
• Serve as Subject Matter Advisor for in‑country performance on Start‑Up and regulatory activities.
• Provide support for local investigator contracts, budget negotiation, and contract execution.

Qualifications

• Bachelor’s Degree.
• Detailed understanding of clinical trial processes (Phases I–IV) and ICH GCP.
• Experience with clinical trial start‑up processes and regulatory submissions.
• Strong organizational skills and ability to manage multiple tasks.
• Excellent written and verbal communication and interpersonal skills.
• Ability to manage project budgets and negotiate contracts.
• Quality‑driven mindset and strong problem‑solving skills.

Over the past 5 years, Syneos Health has supported 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.

Additional Information: Tasks, duties, and responsibilities may be assigned by the Company. The Company may determine equivalence of experience, skills, or education. This description is intended to comply with employment legislation in each operating country, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act and will provide reasonable accommodations where appropriate.

Summary: Roles within the Site Start‑Up job family manage and execute site identification and regulatory processes, ensuring compliance with regulations and project requirements.