[Hiring] Senior Site Activation Specialist @Syneos Health

Role Description

Responsible for quality deliverables at the country level; follows project requirements and applicable country rules, with minimal oversight from the SSU Country Manager. Key responsibilities include:

• Forecasting submission/approval timelines, ensuring compliance, and tracking milestone progress in real time.
• Analyzing data to provide clear rationale for delays and providing contingency plans to mitigate impact.
• Monitoring financial aspects of the project and escalating discrepancies in a timely fashion.
• Reviewing and complying with Standard Operating Procedures (SOPs) and Work Instructions (WI).
• Ensuring all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
• Ensuring continuous improvement of quality in all Site Start-Up (SSU) components at the country level.
• May be involved in vendor management.

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

• Local Submissions Specialist:
  • Follows project direction and expertise provided by the designated country start-up advisor (CSA) and PM/SAM.
  • May serve as the primary point of contact for the PM/SAM during start-up on allocated projects.
  • Compiles and/or reviews essential document packages for site activation.
  • Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory submissions.
• Oversees ongoing submissions, amendments, and periodic notifications required by central and local EC and RA.
• May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues.
• Country Start-Up Advisor: Acts as Subject Matter Expert for in-country performance within the Site Start-Up.
• Ensures local country regulatory intelligence is maintained on the central repository.
• Provides clear data protection guidance at a country level on necessary documents.
• Responsible for identifying solutions with EC or CA issue resolution at the country level.
• Local Site ID and Feasibility Support: Provides support to ensure appropriate sites are selected for individual studies.
• Local Investigator Contract and Budget Negotiator:
  • Produces site-specific contracts from country clinical trial agreement (CTA) template.
  • Negotiates budget and contract with site until resolution of issues.
  • Performs quality control and arranges execution of CTAs.
• Line management / mentoring responsibilities may include supporting management in activities such as interviewing and selection.
• May act as Country Delivery Lead, responsible for operational delivery across the county portfolio.

Qualifications

• Experience in clinical trial regulatory processes.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently with minimal oversight.

Requirements

• Knowledge of local regulatory requirements and processes.
• Experience in site activation and start-up processes.
• Ability to manage multiple tasks and projects simultaneously.
• Proficiency in relevant software and tracking systems.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Inclusive culture that encourages authenticity.