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Site Activation Manager
Syneos Health. Collaborate with Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trial start-up processes, regulatory activities, and project timelines while ensuring compliance with ICH GCP standards. Proficient in vendor management, budget oversight, and effective communication in both German and English.
Highest-signal resume keywords
Clinical Trial Start-Up ProcessesRegulatory Activities ManagementProject Management ExperienceFluency in German and EnglishVendor Management 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
Clinical Trial ProcessRegulatory PathwaysProject Scope ManagementBudget OversightRisk MitigationClinical ProtocolsSubmission Documents PreparationQuality ReviewTimeline DevelopmentData Management
Soft Skills
Excellent Communication SkillsStrong Organizational SkillsProblem-Solving SkillsNegotiating SkillsInterpersonal Skills
Certifications & Qualifications
Bachelor's DegreeHigher Degree Preferred
Industry Keywords
ICH GCPSwiss SubmissionsClinical Trial AgreementsSubject Information SheetsInformed Consent FormsTrial Master FilePatient EnrollmentSite Start-Up IssuesAmendment SubmissionsSSU Change Initiatives
About the role
Key responsibilities & impact- 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 issues, regulatory pathways, patient enrollment matters and complex data
- Ensure project deliverables meet internal and customer expectations
- Develop and maintain customer relationships
- Provide oversight of project start-up deliverables and life-cycle maintenance activities
- Oversee regulatory activities, amendment submissions, communications with authorities and ethics committees, and import/export license extensions
- Oversee executed amended clinical trial agreements and investigator budgets
- Manage overall SSU timelines following site activation
- Update plans according to SOPs and sponsor-scoped processes
- Develop and manage integrated timelines and report weekly progress
- Prepare and present SSU strategy and status at client meetings
- Review SSU budgets and take corrective measures to maintain profitability
- Manage project scope, timelines, resources and budgets
- Track out-of-scope work until assignment to backlog
- Prepare core submission documents and clinical trial application dossiers for amendments
- Perform Regulatory Impact Assessments and oversee risk mitigation
- Assist with updates to master Subject Information Sheets and Informed Consent Forms
- Oversee collation, quality review and submission of country-specific applications
- Contribute to SSU change initiatives
- Ensure relevant documents are submitted to the Trial Master File
Requirements
What you’ll need- Bachelor’s Degree; 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
- Experience in Swiss submissions
- 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
- Fluency in German and English
- Quality-driven in all managed activities
- Strong negotiating skills
- Strong problem-solving skills
- Ability to provide quality feedback and guidance to peers
- 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 and total rewards program
- Inclusive culture
- Two days per week in the Luzern office
- Minimal travel may be required (up to 25%)