Global Site Activation Manager

Syneos Health

. Collaborate with major functional areas across clinical trial operations and business functions .

Posted 9/29/2026full-timeCroatiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site start-up processes, regulatory pathways, and clinical trial activation, with a strong ability to manage project budgets, timelines, and resources while ensuring compliance with SOPs and regulatory requirements.

Highest-signal resume keywords

Site Start-Up ExpertiseRegulatory Submissions KnowledgeProject Budget ManagementClinical Trial Agreements OversightCore Submission Document Preparation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site Start-UpRegulatory PathwaysClinical Trial ActivationProject ManagementBudget ManagementRisk MitigationCore Submission DocumentsRegulatory Impact AssessmentsSubject Information Sheets (SIS)Informed Consent Forms (ICF)

Soft Skills

CollaborationCustomer Relationship ManagementCommunicationProblem SolvingPresentation Skills

Tools & Technologies

Planning ToolsManagement Tools

Industry Keywords

Clinical Trial OperationsTrial Master File (TMF)Essential Document CollectionStudy MaintenanceEthics Committee Communications

About the role

Key responsibilities & impact

Collaborate with major functional areas across clinical trial operations and business functions
Identify and evaluate issues related to Site Start-Up, regulatory pathways, patient enrollment, and complex data
Ensure project deliverables meet internal and customer expectations
Provide projections, reports, updates, and ongoing risk identification, mitigation, and management
Develop and maintain customer relationships
Provide oversight of project start-up deliverables from site selection through site activation and lifecycle maintenance
Oversee regulatory activities, clinical trial agreements, investigator budgets, essential documents, and SSU timelines
Develop plans according to SOPs and sponsor-scoped processes
Report weekly progress and address timing risks or gaps
Present SSU strategy and status at client meetings
Review project SSU budgets and take corrective measures to maintain profitability
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 communicate risk mitigation
Develop or update master SIS/ICF with Project Management and Medical departments
Oversee country-specific application collation, quality review, and submission
Contribute to SSU department change initiatives
Submit relevant documents to the Trial Master File (TMF)
Perform other assigned work-related duties

Requirements

What you’ll need

Homebased in Croatia
Experience and expertise in site start-up, project regulatory pathways, and clinical trial activation
Ability to collaborate with Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing
Ability to manage site identification and selection
Knowledge of regulatory submissions, competent authorities and ethics committee communications, import/export licenses, study maintenance, and amendment submissions
Experience overseeing clinical trial agreements and investigator budgets
Experience establishing and overseeing essential document collection through site activation
Ability to develop and manage integrated site start-up timelines
Ability to prepare and present SSU strategy and status to clients
Ability to manage project budgets, scope, timelines, resources, and profitability
Proficiency with professionally recognized planning and management tools
Experience preparing core submission documents and clinical trial application dossiers
Experience performing Regulatory Impact Assessments
Experience developing Subject Information Sheets (SIS) and Informed Consent Forms (ICF)
Experience overseeing country-specific application collation, quality review, and submission
Ability to comply with Standard Operating Procedures, controlled document requirements, and sponsor processes
Ability to ensure relevant documents are submitted to the Trial Master File (TMF)

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Minimal travel may be required (up to 25%)