03 ott - Frosinone
Premier Research
Overview
Senior 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.
Responsabilità Manage full contract lifecycle for NDAs, CTAs, amendments and related documents for assigned studies
Oversight of investigator site negotiations with country experts
Lead negotiation of site contract templates with Sponsors and liaise with country experts
Develop and maintain templates for CTAs, NDAs, ensuring local legal compliance
Support quality assurance of site contracts
Identify contract and budget risks and propose mitigation
Represent Contracts Department in Sponsor Kick-Off meetings
Oversee study timelines, milestones, and deliverables related to site contracts
Review and advise on Regulatory and Clinical Operations SOPs, WGs, and Ads for NDAs, CTAs, investigator grants, and POA letters
Requisiti fondamentali 5+ years of Contract Lead experience in clinical research or related industry
Experience overseeing site contract negotiations at regional/global level
Knowledge of basics of contracts, NDAs, powers of attorney and related documents
Knowledge of Privacy Laws and cross-border data
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