Description
Syneos Health is seeking a Site Activation Manager, APAC to join their team. The successful candidate will collaborate with major functional areas including Business Development, Alliance Management, and Project Management to ensure site activation and project deliverables meet internal and customer expectations.
Responsibilities:
- Collaborate with cross-functional teams to identify and evaluate fundamental issues pertaining to Site Start-Up, project regulatory pathway, and patient enrollment
- Ensure 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 site selection, site activation, and life cycle maintenance
- Assume accountability for start-up deliverables, including site identification and selection, regulatory activities, and oversight of delivery of executed clinical trial agreements
- Develop plans in accordance with Standard Operating Procedures and sponsor-scoped processes
- Manage integrated site start-up timelines and report weekly progress
- Prepare and present overall SSU strategy and status at client meetings
- Review project SSU budget with functional leads and take corrective measures where necessary
- 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
- Assist in initial or 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
Other Responsibilities:
- 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%)