Study Start Up Specialist - Senior - Spain - FSP
# Study Start Up Specialist - Senior - Spain - FSP **Parexel** · Spain · `Remote` · `Full Time` 💼 **Уровень роли:** `Senior` 🕒 **Статус:** *Опубликовано: сегодня* · *Источник: Himalayas (JSON API)* --- ### Top Skills & Match 🎯 **Ключевой стек роли:** `[Study-Start-Up-Specialist]` `[Clinical-Operations]` `[Regulatory-Affairs]` `[Clinical-Research]` `[Clinical-Trial-Management]` `[Study-Start-Up]` `[Clinical-Study-Start-Up]` `[Start-Up-Specialist]` --- ### About the Role When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at SSU Specialist Senior , home-based and sponsor dedicated, in Spain . The Senior Study Start-up Specialist is responsible for quality deliverables at the country level; follows project requirements and applicable country rules, with minimal oversight from the SSU Manager and contributes to change initiatives across the SSU department. May have Line management/mentoring responsibilities for SSU Specialist. We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success. As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects. The most significant aspect of this position is - Collation and tracking of site feasibility. - Responsible for ensuring CDA is in place. - Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information within JVRIM/CTIS, and similar information for other related organizations, for the assigned country eg IRAS - Responsible for ensuring clinical trial insurance is in place for submission. - Responsible for the translation and co-ordination of translations for documents required for submission. - Creation, review, and customization of country/site specific Informed Consent Forms (ICFs) - Works with regulatory team members and SSU Lead to secure authorization of regulatory documents. - Works with legal, contract vendor and SSU Lead to secure authorization of contracts. - Collects and reviews initial regulatory packets and site contracts for investigator sites. - Coordinate efforts for all site activation related activities including but not limited to obtaining and maintaining regulatory and ethics approvals, review, and approval of essential documents for IP Release - Prepares ongoing submissions, amendments, and periodic notifications required by central and local IRB/EC, CA, and other local regulatory authorities as needed within the country. Including safety notifications as required by local laws/guidelines. - Ensures all relevant documents are submitted to the Trial Master File (TMF) - Responsible for liaising with local CRA/CTM, Contract Vendor, and Regulatory Lead to enable a rapid clinical trial start up. - Inform team members of completion of regulatory and contractual documents for individual sites. - Attend project meetings with cross functional department leads to provide updates. - Identify site issues (risks) during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues. - Escalate risks (e.g. timelines, etc.) to SSU Lead or CTM, as appropriate. - Reviews and provide feedback to SSU Lead on site performance metrics. - Maintains and manages SSU data tracking entries, reviews for completeness and accuracy. - Facilitates process improvement efforts both within the department and in cooperation with other departments. - Support the creation and development of start-up plans and essential document checklists. From you we expect - Bachelor’s Degree or 3 -5 years’ relevant experience, including 2 years of regulatory & study-start up experience or other relevant experience; or equivalent combination of education, training, and experience. - Pharmaceutical or related industry experience - Previous experience of working in a Start-up team, - Experience of in-house trials/process design - Excellent knowledge of GCP and regulations - Contribute to training within SSU and update SOPs/WI - Ability to work independently in a fast-paced environment. - Strong problem-solving skills - Ability to mentor, lead and motivate more junior staff For an immediate interview, please contact Originally posted on Himalayas
- Study-Start-Up-Specialist
- Clinical-Operations
- Regulatory-Affairs
- Clinical-Research
- Clinical-Trial-Management
- Study-Start-Up
- Clinical-Study-Start-Up
- Start-Up-Specialist
Наблюдалась 2026-10-03, впервые 2026-10-03, источник — Himalayas (JSON API).