Senior Site Activation Specialist

Syneos Health

. Deliver quality Site Start-Up deliverables at country level with minimal oversight from the SSU Country Manager .

Posted 11/12/2026full-timeCopenhagen • DenmarkSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial processes, particularly in Site Start-Up and regulatory compliance, while effectively managing project timelines and resources. Proven ability to mentor junior staff and facilitate communication between stakeholders to ensure successful site activation.

Highest-signal resume keywords

Clinical Trial ProcessesSite Start-Up ManagementProject ManagementRegulatory ComplianceVendor Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Start-Up ProcessesICH GCPClinical ProtocolsProject TrackingContingency PlanningFinancial MonitoringDocument SubmissionContract NegotiationResource AllocationMetrics Analysis

Soft Skills

Excellent CommunicationStrong Organizational SkillsNegotiating SkillsProblem-Solving SkillsMentoring Ability

Tools & Technologies

SSU Tracking SystemTrial Master File

Industry Keywords

Ethics Committee ApplicationsCompetent AuthoritiesQuality AssuranceSOPsWork Instructions

About the role

Key responsibilities & impact

Deliver quality Site Start-Up deliverables at country level with minimal oversight from the SSU Country Manager
Forecast submission and approval timelines, track milestones in the SSU tracking system, analyze delays, create contingency plans, and escalate issues
Monitor project financial aspects and contracted hours/tasks; escalate discrepancies
Review and comply with SOPs and Work Instructions; maintain training records and timesheet compliance
Submit relevant documents to the Trial Master File according to company and sponsor requirements
Continuously improve country-level Site Start-Up components, including submissions, essential document collection, and communications with Competent Authorities and Ethics Committees
Manage local submissions, regulatory and Ethics Committee applications, amendments, periodic notifications, and safety notifications
Facilitate communication between investigational sites and functional leads and oversee site activation end to end
Provide country-level regulatory intelligence and data protection guidance
Support site selection and feasibility activities
Prepare, review, negotiate, execute, and archive investigator contracts, site contracts, and budgets when assigned
Support interviewing, selection, professional development, performance management, counseling, and mentoring of junior staff
Potentially serve as Country Delivery Lead, managing operational delivery through site start-up, site activation, and First Patient In
Analyze country and site metrics and plan country-level resource allocation

Requirements

What you’ll need

Bachelor’s Degree
Excellent understanding of clinical trial processes across Phases II-IV and ICH GCP
Good understanding of clinical protocols and associated study specifications
Excellent understanding of clinical trial start-up processes
Project management experience in a fast-paced environment
Good vendor management skills
Strong organizational skills with proven ability to handle multiple projects
Excellent communication, presentation, and interpersonal skills
Quality-driven in all managed activities
Strong negotiating skills
Strong problem-solving skills
Ability to mentor, lead, and motivate more junior staff
Ability to provide quality feedback and guidance to peers
Ability to contribute to a training and Quality Assurance plan within SSU and update SOPs/WI
Equivalent experience, skills, and/or education may be considered

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture
Diversity, inclusion, and belonging-focused workplace