Overview

In this role, you will oversee site contracts for assigned studies, guiding NDA/CTA activities and sponsor negotiations to ensure regulatory compliance and protection of study interests. You will coordinate with country experts to manage contract execution and timelines, and you’ll shape templates and processes to mitigate risk. You will join a mission-driven team delivering medical innovation that improves lives, with opportunities to grow and balance work with your life. You’ll be at the intersection of law, clinical operations, and regulatory expectations, delivering tangible impact across general studies.

Responsabilidades

- Manage NDAs, CTAs, contract amendments, and related documents for assigned studies
- Oversee investigator site contracts with country experts during negotiations
- Lead terms negotiation of site contract templates with Sponsors at project start
- Develop and maintain templates for CTAs, NDAs, ensuring compliance with local laws
- Support quality assurance of Site Contracts
- Identify site contract and budget risks and propose mitigations
- Represent Contracts Department in Sponsor Kick-Off meetings




- Monitor site contract study timelines, milestones, deliverables, and deadlines
- Review and advise on Regulatory and Clinical Operations SOPs, WGs, and Ads related to NDAs, CTAs, and powers of attorney

Requisitos principales

- 5+ years of Contract Lead experience in clinical research or related industry
- Oversight experience of Site Contracts negotiations teams on regional/global level
- Knowledge 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 Documents, EU Regulations, Local Regulations, ISO14155, drug/device development, and clinical monitoring procedures

- Strong negotiation and stakeholder management
- Attention to detail and risk awareness
- Cross-functional collaboration
- Site Contract negotiation
- NDA and CTA drafting and management
- Regulatory compliance understanding (privacy, ICH/GCP)

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