Description
Syneos Health is seeking a Site Activation Manager to join their team in Luzern, Switzerland. As a Site Activation Manager, you will collaborate with major functional areas including Business Development, Alliance Management, and Project Management to ensure successful site activation and project deliverables.
Responsibilities:
- Collaborate with cross-functional teams to identify and evaluate fundamental issues pertaining to Site Start-Up, project regulatory pathway, and patient enrollment
- Ensure all project deliverables meet internal and customer expectations, providing accurate projections, reports, and updates
- Develop and maintain relationships with customers and ensure individual project targets and client needs are met
- Provide oversight of all project start-up deliverables, including life cycle maintenance regulatory activities and study maintenance
- Develop and manage integrated timelines and reports weekly progress, including plans to address potential timing risks/gaps
- Prepare and present overall SSU strategy and status at client meetings and communicate outcomes to project teams
- Review project SSU budget with functional leads, PM, and SSU Business Unit Controller against project milestones and budget
- Use professionally recognized tools for planning and management of scope, timeline, and resources
- Prepare core submission documents and core clinical trial application dossier for amendments
- Perform Regulatory Impact Assessment on core amendment submission documents and communicate risk mitigation to Sponsor/Project teams
- Assist in amendment updated development of master Subject Information Sheet (SIS) /Informed Consent Form (ICF)
- Oversee collation, quality review, and submission of country-specific applications
- Contribute to change initiatives across and within the SSU department
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements
- Minimal travel may be required (up to 25%)
Syneos Health is committed to developing their people, building an inclusive culture, and delivering high-quality services to their customers.