Description
Syneos Health is seeking a Site Activation Manager II to join their Clinical Solutions 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.
Key responsibilities include:
- Collaborating with cross-functional teams to identify and evaluate fundamental issues pertaining to site start-up and project regulatory pathways
- Ensuring all project deliverables meet internal and customer expectations, providing accurate projections, reports, and updates
- Developing and maintaining relationships with customers and ensuring individual project targets and client needs are met
- Providing oversight of all project start-up deliverables, including site selection, site activation, and life cycle maintenance
- Developing plans in accordance with Standard Operating Procedures and sponsor-scoped processes
- Managing integrated site start-up timelines and reporting weekly progress
- Preparing and presenting overall SSU strategy and status at client meetings
- Reviewing project SSU budget with functional leads, PM, and SSU Business Unit Controller
- Using professionally recognized tools for planning and management of scope, timeline, and resources
- Preparing core submission documents and core clinical trial application dossiers for amendments
- Performing Regulatory Impact Assessments on core amendment submission documents
- Contributing to change initiatives across and within the SSU department
The ideal candidate will have experience in site activation, project management, and regulatory affairs, with a strong understanding of pharmaceutical development and commercialization.