SSU & Regulatory Specialist II

$74,460 - $95,900/Yr

inVentiv Health - State College, PA

Full-time - Mid Level

State College, PA

10,001+ employees

Professional, Scientific, and Technical Services

About the position

The Site Start-Up & Regulatory Specialist II at Syneos Health is responsible for ensuring quality deliverables at the country level in compliance with project requirements and local regulations. This role involves monitoring submission timelines, managing project budgets, and supporting continuous improvement in site start-up processes. The specialist will also act as a liaison for various regulatory submissions and assist in contract negotiations, contributing to the overall success of clinical trials.

Responsibilities

• Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules, with moderate oversight from the SSU Country Manager.
• Works within the forecasted submission/approval timelines and ensures compliance, tracking milestone progress in the SSU tracking system.
• Monitors basic financial aspects of the project and escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs), keeping training records updated and ensuring timesheet compliance.
• Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
• Acts as a Local Submissions Specialist, following project direction and preparing necessary regulatory submissions.
• Prepares ongoing submissions, amendments, and notifications required by central and local regulatory authorities.
• Acts as a Country Start-Up Advisor, providing in-country performance support and maintaining regulatory intelligence.
• Provides support with site selection and ensures appropriate sites are selected for studies.
• Supports contract and budget negotiations with sites.

Requirements

• Bachelor's Degree
• 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
• Strong organizational skills with ability to handle multiple tasks effectively
• Strong 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.

Benefits

• Company car or car allowance
• Health benefits including Medical, Dental, and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time