Study Start Up Specialist/Senior - FSP - Remote

Experteer Italy; Italia; Remoto; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A specialized clinical research organization is seeking an SSU Specialist to join their remote team in Italy. The successful candidate will manage site feasibility, ensure regulatory compliance, and participate in study set-up. Ideal candidates have 3-5 years of experience in regulatory and study start-up, with strong knowledge of GCP. This full-time role offers opportunities for career development in a supportive work environment.

Competenze

• 3-5 years of relevant experience, including 2 years of regulatory and study-start up experience.
• Previous experience of working in a Start-up team.
• Contribute to training within SSU and update SOPs/WI.

Mansioni

• Collation and tracking of site feasibility.
• Creation, review, and customization of country/site specific Informed Consent Forms.
• Uploads time critical documents to eTMF.

Conoscenze

Regulatory & study-start up experience

Excellent knowledge of GCP and regulations

Experience in in-house trials/process design

Pharmaceutical industry experience

Formazione

Bachelor’s Degree

Descrizione del lavoro

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.

Parexel is currently seeking an experienced SSU Specialist to join us in Italy. You will be assigned to one of our key sponsors in the region.

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.

Whether you see your future path in fields such as clinical operations, project management, line management, or other positions, we have a world of opportunity waiting for you.

Some specifics about this advertised role

• Dedicated to one client.

• 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.
• 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.
• Actively participates in local study team and set-up team meetings.
• Uploads time critical documents to eTMF

Here are a few requirements specific to this advertised role.

• Bachelor’s Degree or 3 -5 years’ relevant experience, including 2 years of regulatory & study-start up experience or other relevant experience In depth experience of performing SSU activities.
• 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

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long‑term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best‑selling drugs, but equally we enable more niche drug developments that are critical to the well‑being of many patients.

You’ll be an influential member of the wider team.

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Summary

• Location: Italy-Remote
• Type: Full time