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.

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