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 marta.kuniewicz@parexel.com
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