Senior Site Contracts Lead

44 Premier Research S.r.l.; Italia; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

44 Premier Research S.r.l. is seeking a Senior Site Contracts Lead to join our Regulatory Submissions and Contracts team in Italy.

You will manage NDAs, CTAs, contract amendments, and related docs for assigned studies, while coordinating with country experts during investigator site negotiations and aligning with Sponsors. The role requires 5+ years in contract leadership within clinical research, knowledge of NDA/CTA processes, and familiarity with international privacy laws and regulatory

Competenze

• Undergraduate degree in legal studies or life sciences from an accredited institution.
• Law degree preferred.
• 5+ years of Contract Lead experience in clinical research or related industry, including oversight of site contracts negotiations teams at regional/global level.
• Knowledge of basic requirements of contracts, NDAs, powers of attorney and related documents.
• Knowledge of Privacy Laws and regulations pertaining to cross border transfer of data.
• Knowledge of ICH / GCP regulations.
• Working knowledge of FDA Guidance Documents / EU Regulations / Local Regulations / ISO14155 regulations, drug/device development, and clinical monitoring procedures.

Mansioni

• Manage all aspects of implementing NDAs, CTAs, Contract Amendments, and related documents for assigned studies.
• Oversee site contracts with country experts during investigator site negotiations.
• Lead negotiation of site contract templates with Sponsors and liaise between Sponsors and country experts.
• Develop and maintain templates for CTAs, NDAs, and related compliance documents.
• Support quality assurance of all Site Contracts.
• Identify site contract and budget risks and propose mitigations.
• Represent Contracts Department in Sponsor Kick-Off meetings.
• Oversee study timelines, milestones, and deadlines related to site contracts.

Conoscenze

Contract negotiations

Site contracts

NDAs/CTAs

Regulatory compliance

Formazione

Undergraduate degree in legal studies or life sciences

Law degree

Descrizione del lavoro

Premier Research is looking for a Senior Site Contracts Lead to join our Regulatory Submissions and Contracts team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What You'll Be Doing:

• Managing all aspects of implementing Non-Disclosure Agreements, Clinical Trial Agreements, Contract Amendments, and other associated documents for assigned studies.
• Oversight of all Site Contracts with country experts during the process of investigator site negotiation for assigned studies.
• Leading the negotiation of terms of all Site Contract templates with each Sponsor at the beginning of each project and, serving as liaison between the Sponsors and country experts in all negotiations.
• Assisting with the development and maintenance of templates for CTAs, NDAs, and other documents enduring compliance with local legal requirements.
• Supporting quality of all Site Contracts.
• Proactively identifies site contract and budget related risks and suggests solutions to resolve or mitigate.
• Representing Premier Research Contracts Department during Sponsor Kick-Off meetings.
• Oversees site contract related study timelines, milestones, deliverables and deadlines throughout the study.
• Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and Ads related to NDAs, CTAs, investigator grants and letters of authorization of Powers of Attorney.

What We Are Searching For:

• Undergraduate degree or its international equivalent in legal studies or life sciences from an accredited institution.
• Law degree preferred.
• 5+ years of Contract Lead experience in clinical research, or related industry, including oversight of Site Contracts negotiations teams on regional / global level.
• Knowledge of basic requirements of contracts, non-disclosure agreements, powers of attorney and related documents.
• Knowledge of Privacy Laws and regulations pertaining to cross border transfer of data.
• Knowledge of ICH / GCP regulations.
• Working knowledge of FDA Guidance Documents / EU Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.

Premier Research is more than a company - it's a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning. Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests. Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.