Senior Site Contracts Lead
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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
- 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 transfer regulations
- Knowledge of ICH/GCP regulations
- Working knowledge of FDA guidance, EU regulations, local regulations, and ISO14155, drug/device development, and clinical monitoring procedures
- strong negotiation skills
- stakeholder management
- cross-functional collaboration
- NDA and CTA drafting and negotiation
- site contract management
- regulatory and legal documentation
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