Description
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Job Responsibilities
The Site Activation Manager II is responsible and accountable for the customer-focused leadership and management of Site Start-Up (SSU) deliverables within a country, region or globally, within the assigned projects. Directs the technical and operational aspects of the Site Start-Up deliverables of the assigned projects. Accountable for the delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations.
Key responsibilities:
- Collaborates with major functional areas, including Business Development, Alliance Management, and Project Management
- Identifies and evaluates fundamental issues pertaining to Site Start-Up, project regulatory pathway, and patient enrollment
- Ensures all project deliverables meet internal and customer expectations
- Develops and maintains relationships with customers
- Provides oversight of all project start-up deliverables, including site selection, site activation, and life cycle maintenance
- Assumes accountability on start-up deliverables, including site identification and selection, regulatory activities, and essential document collection
- Develops plans in accordance with Standard Operating Procedures and sponsor-scoped processes
- Develops and manages integrated site start-up timelines and reports weekly progress
- Prepares and presents overall SSU strategy and status at client meetings
- Reviews project SSU budget with functional leads, PM, and SSU Business Unit Controller
- Uses professionally recognized tools for planning and management of scope, timeline, and resources
- Prepares core submission documents and core clinical trial application dossier for amendments
- Performs Regulatory Impact Assessment on core amendment submission documents
- Assists in initial or amendment updated development of master Subject Information Sheet (SIS) /Informed Consent Form (ICF)
- Oversees collation, quality review, and submission of country-specific applications
- Contributes to change initiatives across and within the SSU department
Qualifications & Requirements
- Bachelor's Degree, Higher Degree Preferred
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
- Good understanding clinical protocols and associated study specifications
- Excellent understanding of clinical trial start-up processes
- 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
- Quality-driven in all managed activities
- Strong problem-solving skills
- Demonstrate an ability to provide quality feedback and guidance to peers