Why This Role
This is a high-visibility opportunity for outstanding Site Activation Managers ready to step into a more strategic, sponsor-facing role within an FSP model. You'll lead global site activation efforts while helping shape processes in a fast-evolving environment.
What You'll Own
End-to-End SSU Leadership
Drive global site start-up strategy and execution from site identification through activation and lifecycle maintenance
Own SSU timelines, forecasts, and delivery against contracted milestones
Identify risks early (regulatory, enrollment, timelines) and implement mitigation plans
Operational Oversight
Lead all start-up deliverables, including:
Site identification and feasibility
Regulatory submissions and lifecycle maintenance (amendments, HA/EC communications, licenses)
CTA and investigator budget negotiation/execution
Essential document collection and TMF readiness
Ensure delivery aligns with SOPs, sponsor expectations, and quality standards
Sponsor & Cross-Functional Engagement
Act as a key interface with sponsor stakeholders, presenting strategy, risks, and status
Partner across Clinical Ops, PM, Contracts, Data Management, Medical Writing, and SSU Country teams
Collaborate within a team-first, highly accountable FSP environment
Financial & Scope Accountability
Review SSU budgets vs. milestones and support profitability targets
Track and manage out-of-scope activities in partnership with PM/SSU leadership
Regulatory Leadership
Oversee preparation of core submission documents and amendment dossiers
Conduct Regulatory Impact Assessments and communicate risks
Support development of SIS/ICF documents and country-specific submissions
Process & Build Mindset
Contribute to process creation and refinement as the team scales
Operate effectively in a setting where execution and process development happen in parallel
Required Experience
Minimum 3 years prior experience as a Site Activation Manager (SAM).
Minimum of 2 years' experience in Managing large scale, US-based Site Activation with high success.
Strong track record delivering SSU activities across Phase II - IV trials
Solid understanding of ICH-GCP, regulatory pathways, and start-up processes
Demonstrated ability to manage multiple studies and competing priorities
Strong communication, stakeholder management, and problem-solving skills
Highly Preferred
FSP (Functional Service Provider) experience
Prior Global SAM responsibility (regional experience considered with strong performance, if US based sites.)
Experience integrating Syneos and sponsor systems
Proven ability to operate in ambiguity and help build processes while delivering
Track record of high performance and readiness for increased scope/visibility