[Hiring] Senior Site Start-Up & Regulatory Specialist @Syneos Health

Role Description

The Sr Site Start-Up & Regulatory Specialist is responsible for quality deliverables at the country level, following project requirements and applicable country rules with minimal oversight from the SSU Country Manager. Key responsibilities include:

• Forecasting submission/approval timelines and ensuring compliance.
• Tracking milestone progress in the SSU tracking system in real time.
• Analyzing data to provide rationale for delays and offering contingency plans.
• Monitoring financial aspects of the project and escalating discrepancies.
• Reviewing and complying with Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Ensuring all relevant documents are submitted to the Trial Master File (TMF).
• Continuous improvement of quality in all Site Start-Up (SSU) components.
• Vendor management involvement as needed.

Responsible for one or more of the following functions at the country level:

• Local Submissions Specialist:
  • Follows project direction from the designated country start-up advisor (CSA) and PM/SAM.
  • Compiles and reviews essential document packages for site activation.
  • Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other submissions.
• Oversees ongoing submissions, amendments, and notifications required by central and local EC and RA.
• Acts as liaison between investigational sites and functional leads.
• Country Start-Up Advisor:
  • Acts as Subject Matter Expert for in-country performance within Site Start-Up.
  • Maintains local country regulatory intelligence on a central repository.
  • Provides data protection guidance at a country level.
  • Supports the creation of internal training materials on local legislation requirements.
• Local Site ID and Feasibility Support:
  • Supports site selection lead and PM/SAM to ensure appropriate sites are selected.
• Local Investigator Contract and Budget Negotiator:
  • Produces and reviews site-specific contracts from country clinical trial agreement (CTA) template.
  • Negotiates budget and contract with site and via Site Contracts Service Centre.
  • Performs quality control and arranges execution of CTAs.
• Line Management / Mentoring Responsibilities:
  • Provides support in activities such as interviewing, professional development, and performance management.
  • Advises junior team members on administrative policies and procedures.
• Country Delivery Lead:
  • Responsible for operational delivery across the country portfolio.
  • Analyzes country and site metrics to ensure project deliverables are met.
  • Performs operational site level planning.

Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Qualifications

• Experience in site start-up and regulatory processes.
• Strong understanding of local regulatory requirements.
• Excellent communication and negotiation skills.
• Ability to work independently and manage multiple tasks.

Requirements

• Relevant degree in life sciences or related field.
• Proven experience in clinical trial management.
• Familiarity with regulatory submissions and compliance.
• Strong analytical and problem-solving skills.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Inclusive culture where you can authentically be yourself.