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 e.g. 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; accelerate 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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