Sponsor dedicated SSU
hace 1 semana
Overview Sponsor dedicated SSU & Regulatory Specialist II. Madrid. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient, with a focus on simplifying and streamlining work. Located in Madrid, this role supports Site Start-Up (SSU) activities at the country level. Responsibilities Responsible for quality deliverables at the country level; follow project requirements and applicable country rules with moderate oversight. Track milestone progress in the SSU tracking system in real time; investigate delays, provide rationale, support contingency plans, and escalate issues as needed. Monitor basic financial aspects of the project and hours/tasks per contract; escalate discrepancies in a timely fashion. Review and comply with SOPs and WIs; keep training records updated and ensure timesheet compliance. Support continuous improvement of SSU components at the country level (submissions, essential document collection, communications to authorities, etc.). Ensure relevant documents are submitted to the Trial Master File (TMF) per SOP/Sponsor requirements. Local Submissions Specialist: follow project direction from the CSA and SAM; may serve as PM/SAM contact during start-up; prepare and submit local regulatory submissions as required; manage ongoing submissions and amendments within country with moderate oversight from the SSU Country Manager. Act as liaison between investigational sites and functional leads; oversee site activation end-to-end at country/site level. Country Start-Up Advisor: provide SME guidance on in-country performance, regulatory intelligence, and local SOP/WIs; support data protection and local legislation requirements; contribute to EC/CA issue resolution; support site feasibility and selection. May be involved in Local Investigator Contracts and Budget Negotiation, CTAs execution, archival of documents, and metadata capture. Qualifications Bachelor’s Degree. Detailed understanding of clinical trial processes across Phases II-IV and ICH GCP. Ability to understand clinical protocols and study specifications; knowledge of start-up processes. Ability to manage external vendors to contract effectively. Strong organizational, written, and verbal communication skills. Ability to manage multiple project budgets with increasing complexity and value. Quality-driven approach; good negotiation and problem-solving skills. Ability to work independently and as part of a team. Additional Information Tasks, duties, and responsibilities are not exhaustive. The company may assign additional tasks at its discretion. Syneos Health is an Equal Opportunity Employer. If you require reasonable accommodation to complete any part of the application process, please contact Summary: Roles within the Site Start-Up/Site ID family manage site identification in compliance with regulations, SOPs, and project requirements, including CDA/SIF handling, site performance metrics, and primary contact for investigative sites. Discover what our 29,000 employees already know: work here matters everywhere. Syneos Health is Nasdaq: SYNH. #J-18808-Ljbffr
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