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Site Activation Manager
Syneos Health. Lead and manage customer-focused Site Start-Up deliverables within assigned projects at country, regional, or global level .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Site Start-Up deliverables, ensuring compliance with regulations, and delivering activation-ready study sites on time and within budget. Proficient in project management, vendor management, and maintaining strong customer relationships throughout the clinical trial process.
Highest-signal resume keywords
Clinical Trial Process UnderstandingProject Management ExperienceSite Start-Up Processes ExpertiseRegulatory Compliance KnowledgeStrong Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site Start-Up ManagementRegulatory Impact AssessmentClinical Trial Agreement PreparationBudget MonitoringTimeline DevelopmentRisk Identification and MitigationQuality ReviewClinical Protocol UnderstandingVendor ManagementSubmission Document Preparation
Soft Skills
Organizational SkillsProblem-Solving SkillsNegotiating SkillsInterpersonal SkillsPresentation Skills
Certifications & Qualifications
Bachelor’s DegreeHigher Degree Preferred
Industry Keywords
ICH GCPPhases II-IVClinical TrialSite SelectionStudy Life-Cycle MaintenanceCustomer RelationshipsProject ProfitabilityTrial Master FileEssential Document CollectionSSU Change Initiatives
About the role
Key responsibilities & impact- Lead and manage customer-focused Site Start-Up deliverables within assigned projects at country, regional, or global level
- Direct technical and operational aspects of Site Start-Up deliverables
- Deliver activation-ready study sites on time, on budget, and in compliance with applicable regulations
- Oversee Site Start-Up activities from site selection and recommendation through site activation readiness and study life-cycle maintenance
- Develop Site Start-Up timelines and report progress, risks, and gaps to the project team, Project Manager, SSU Management, and Project Sponsor
- Collaborate with Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing
- Identify and evaluate Site Start-Up and regulatory pathway issues and implement solutions
- Ensure project deliverables meet internal and customer expectations, including projections, reports, updates, risk identification, mitigation, and management
- Develop and maintain customer relationships
- Oversee site identification and selection, regulatory activities, clinical trial agreements, investigator budgets, essential document collection, and SSU timelines
- Develop and manage integrated Site Start-Up timelines and report weekly progress
- Present SSU strategy and status at client meetings and communicate outcomes to project teams
- Review SSU budgets, monitor project profitability, and take corrective measures when necessary
- Manage scope, timelines, resources, budgets, and out-of-scope work
- Prepare core submission documents and clinical trial application dossiers for amendments
- Perform Regulatory Impact Assessments and oversee risk mitigation and review
- Assist with Subject Information Sheet/Informed Consent Form development
- Oversee collation, quality review, and submission of country-specific applications
- Contribute to SSU change initiatives
- Submit relevant documents to the Trial Master File according to company SOPs and sponsor requirements
- Perform other assigned work-related duties
Requirements
What you’ll need- Bachelor’s Degree required; Higher Degree Preferred
- Excellent understanding of clinical trial process 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 provide quality feedback and guidance to peers
- Equivalent experience, skills, and/or education will also be considered
- Minimal travel may be required (up to 25%)
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate