Why This Role<\/p>\n
\tThis 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\u2019ll lead global site activation efforts while helping shape processes in a fast-evolving environment.<\/p>\n
What You\u2019ll Own
\nEnd-to-End SSU Leadership<\/p>\n
\tDrive global site start-up strategy and execution from site identification through activation and lifecycle maintenance
\n\tOwn SSU timelines, forecasts, and delivery against contracted milestones
\n\tIdentify risks early (regulatory, enrollment, timelines) and implement mitigation plans<\/p>\n
Operational Oversight<\/p>\n
\tLead all start-up deliverables, including:
\n\tSite identification and feasibility
\n\tRegulatory submissions and lifecycle maintenance (amendments, HA\/EC communications, licenses)
\n\tCTA and investigator budget\u00a0negotiation\/execution
\n\tEssential document collection and TMF readiness
\n\tEnsure delivery aligns with SOPs, sponsor expectations, and quality standards<\/p>\n
Sponsor & Cross-Functional Engagement<\/p>\n
\tAct as a key interface with sponsor stakeholders, presenting strategy, risks, and status
\n\tPartner across Clinical Ops, PM, Contracts, Data Management, Medical Writing, and SSU Country teams
\n\tCollaborate within a team-first, highly accountable FSP environment<\/p>\n
Financial & Scope Accountability<\/p>\n
\tReview SSU budgets vs. milestones and support profitability targets
\n\tTrack and manage out-of-scope activities in partnership with PM\/SSU leadership<\/p>\n
Regulatory Leadership<\/p>\n
\tOversee preparation of core submission documents and amendment dossiers
\n\tConduct Regulatory Impact Assessments and communicate risks
\n\tSupport development of SIS\/ICF documents and country-specific submissions<\/p>\n
Process & Build Mindset<\/p>\n
\tContribute to process creation and refinement as the team scales
\n\tOperate effectively in a setting where execution and process development happen in parallel<\/p>\n
Required Experience<\/p>\n
\tMinimum 3 years prior experience as a Site Activation Manager (SAM).
\n\tMinimum of 2 years’ experience in\u00a0Managing large scale, US-based Site Activation with high success.
\n\tStrong track record delivering SSU activities across Phase II\u2013IV trials
\n\tSolid understanding of ICH-GCP, regulatory pathways, and start-up processes
\n\tDemonstrated ability to manage multiple studies and competing priorities
\n\tStrong communication, stakeholder management, and problem-solving skills<\/p>\n
Highly Preferred<\/p>\n
\tFSP (Functional Service Provider) experience
\n\tPrior\u00a0Global SAM\u00a0responsibility (regional experience considered with strong performance, if\u00a0US\u00a0based sites.)
\n\tExperience integrating Syneos and sponsor systems
\n\tProven ability to operate in ambiguity and help build processes while delivering
\n\tTrack record of high performance and readiness for increased scope\/visibility<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( ) or<\/p>\n
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