Sponsor Dedicated SSU & Regulatory Specialist II – Madrid
Updated: Yesterday
Location: ESP-Remote (Madrid)
Job ID: 25102455
Company Overview
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate clinical, medical affairs, and commercial insights into outcomes that address modern market realities.
Our Clinical Development model prioritizes both the customer and the patient, streamlining operations to improve efficiency and impact.
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
Career development and progression through technical and therapeutic training, mentorship, and line management support
Peer recognition and total rewards program
Inclusive Total Self culture, promoting authenticity, belonging, and diversity
Continuous company evolution to build a workplace everyone wants to work for
Role Overview
The Sponsor Dedicated SSU & Regulatory Specialist II is responsible for managing site start-up (SSU) and regulatory activities at the country level. The role ensures high-quality deliverables, compliance with regulations, and efficient site activation processes.
Key Responsibilities
Country-Level Site Start-Up & Regulatory Tasks
Deliver quality outputs according to project requirements and applicable country rules with oversight from the SSU Country Manager
Track milestone progress in the SSU tracking system; investigate delays and implement contingency plans
Monitor project budgets, hours, and task allocations; escalate discrepancies as needed
Review and comply with SOPs, Work Instructions (WI), and maintain training records
Submit all relevant documents to the Trial Master File (TMF) per SOP/Sponsor requirements
Local Submissions Specialist Duties
Follow guidance from the Country Start-Up Advisor (CSA) and SAM
Act as point of contact for PM/SAM during start-up on assigned projects
Prepare and submit Central EC, Local EC, RA, and other regulatory/hospital approval submissions
Manage ongoing submissions, amendments, and periodic notifications, including safety notifications
Serve as liaison between investigative sites and functional leads
Country Start-Up Advisor Support
Provide subject matter expertise for in-country SSU performance and regulatory intelligence
Maintain regulatory intelligence in central repositories (CA submissions, EC submissions, data protection notifications, import/export licenses)
Support data protection compliance, informed consent, and confidentiality agreements
Provide input to SOPs, WIs, and internal training materials
Assist with issue resolution at the country level
Local Site ID & Feasibility Support
Collaborate with site selection leads and PM/SAM to select appropriate sites
Assist with local investigator contract and budget negotiation
Produce site-specific contracts from country templates
Support contract and budget submissions and negotiations until execution
Perform quality control, arrange execution of CTAs, and archive documents with metadata
Qualifications
Bachelor’s Degree
Detailed understanding of clinical trial processes (Phases II–IV) and ICH GCP
Ability to interpret clinical protocols and study specifications
Strong understanding of clinical trial start-up processes
Ability to manage external vendors and contracts effectively
Strong organizational, written, and verbal communication skills
Ability to handle multiple project budgets and tasks simultaneously
Quality-driven with good problem-solving and negotiating skills
Ability to work independently and collaboratively
Company Highlights
Supported 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products over the past 5 years
Contributed to 200+ studies across 73,000 sites and 675,000+ trial patients
Encourages initiative, process improvement, and challenging the status quo
Learn more: Syneos Health
Additional Information
Job duties may be revised at the company’s discretion
Equivalent experience, skills, or education may be considered
Nothing in the posting constitutes an employment contract
Complies with applicable employment laws and regulations, including the Americans with Disabilities Act
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