Senior Site Contracts Lead - Global Clinical Agreements

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

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