bOverview /b pSenior Site Contracts Lead to guide site contract lifecycle across studies, ensuring compliant negotiations and templates. You will coordinate with country experts, sponsors, and the Contracts Department to manage NDAs, CTAs, amendments, and related documents. The role focuses on risk mitigation, timeline control, and regulatory alignment to enable medical innovation. You will shape templates, advise on SOPs, and represent Contracts in sponsor kick-off meetings. This is a mission-driven role with meaningful impact on patient outcomes. /p bResponsabilità /bulliManage full contract lifecycle for NDAs, CTAs, amendments and related documents for assigned studies /liliOversight of investigator site negotiations with country experts /liliLead negotiation of site contract templates with Sponsors and liaise with country experts /liliDevelop and maintain templates for CTAs, NDAs, ensuring local legal compliance /liliSupport quality assurance of site contracts /liliIdentify contract and budget risks and propose mitigation /liliRepresent Contracts Department in Sponsor Kick-Off meetings /liliOversee study timelines,



milestones, and deliverables related to site contracts /liliReview and advise on Regulatory and Clinical Operations SOPs, WGs, and Ads for NDAs, CTAs, investigator grants, and POA letters /li /ul bRequisiti fondamentali /bulli5+ years of Contract Lead experience in clinical research or related industry /liliExperience overseeing site contract negotiations at regional/global level /liliKnowledge of basics of contracts, NDAs, powers of attorney and related documents /liliKnowledge of Privacy Laws and cross-border data transfer regulations /liliKnowledge of ICH/GCP regulations /liliWorking knowledge of FDA guidance, EU regulations, local regulations, and ISO14155, drug/device development, and clinical monitoring procedures /li /ulullistrong negotiation skills /lilistakeholder management /lilicross-functional collaboration /liliNDA and CTA drafting and negotiation /lilisite contract management /liliregulatory and legal documentation /li /ul

📌 Senior Site Contracts Lead (Lucca)
🏢 Premier Research
📍 Lucca