Syneos Health
SSUSII
“SSUS II at Syneos Health. Responsible for quality deliverables at country level. Works within forecasted submission/approval timelines”
What You'll Achieve.
accelerate customer success; navigate complexity, anticipate change and accelerate progress; help our customers achieve their goals; driving impact for customers and defining the pace of patient progress
Industry & Context.
Good problem-solving skills
What They're Looking For.
Must Have
Detailed understanding of clinical trial process across Phases II-IV and ICH GCP, Ability to understand clinical protocols and associated study specifications, Detailed understanding of clinical trial start-up processes, Ability to manage external vendors to contract effectively, organizational skills with ability to handle multiple tasks effectively, written and verbal communication and interpersonal skills, Ability to manage multiple project budgets with increased complexity and value, Quality-driven in all managed activities, Good negotiating skills, Good problem-solving skills, Demonstrated ability to work independently as well as part of a team
What You'll Do.
Responsible for quality deliverables at country level
Works within forecasted submission/approval timelines
Tracks milestone progress in SSU tracking system
Monitors basic financial aspects of the project
Reviews and complies with SOPs and Work Instructions
Supports continuous improvement of quality in SSU components
Ensure all relevant documents submitted to TMF
Responsible for Local Submissions Specialist
Prepares and submits Central EC Applications
Prepares ongoing submissions
and periodic notifications
Acts as liaison and facilitator between investigational sites
Oversee site activation end to end process
Acts as Subject Matter Advisor for in-country performance
Supports country-level intelligence on start-up
Ensures local country regulatory intelligence is maintained
Provides input in local SOPs and WI
Supports the creation of internal training materials
Provides input to the team to assist with EC or CA issue resolution
Provides support with site selection lead
Provides support to SAM to agree on country template contract
Produces site-specific contracts from country template
Performs quality control and arranges execution of CTAs
How You'll Work.
Team & Collaboration
collaborate with passionate problem solvers, innovating as a team; Demonstrated ability to work independently as well as part of a team
Communication Scope
written and verbal communication and interpersonal skills
Process & Methodology
Ability to manage multiple project budgets with increased complexity and value
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