Parexel
Study Start Up Specialist - Senior - Spain - FSP
About this 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)