Position Overview
We are seeking an experienced and strategic Site Contract Manager with global clinical trial experience to oversee the negotiation and execution of site agreements across international research sites. This role is essential in supporting our global clinical development programs by ensuring compliant, timely, and cost-effective contracting solutions.
The ideal candidate will have a strong background in managing clinical contracts across multiple countries and regions, with a deep understanding of regulatory nuances, cultural considerations, and market-specific requirements in North America, Europe, APAC.
Key Responsibilities
- Lead the end-to-end negotiation and execution of Clinical Trial Agreements (CTAs), CDAs, and amendments with investigative sites and institutions globally.
- Collaborate cross-functionally with legal, clinical operations, regulatory, and finance teams to ensure contract alignment with global study goals and local requirements.
- Provide expertise on country-specific legal and compliance frameworks, including GDPR, anti-bribery laws, local data privacy rules, and regulatory contracting standards.
- Act as the primary point of contact for global site contracting activities across studies, ensuring consistency in negotiation strategy while adapting to local regulations and customs.
- Partner with CROs, vendors, and in-country affiliates to drive contract timelines and resolve any issues related to contract terms or site requirements.
- Monitor contracting KPIs and performance metrics; provide leadership with global contracting insights and process improvement recommendations.
- Maintain up-to-date knowledge of global clinical research regulations and best practices to ensure contracts reflect evolving regulatory landscapes.
Qualifications
- Bachelor's degree required; JD, MBA, or advanced legal/clinical degree preferred.
- 5+ years of experience in site contract negotiation and management, with demonstrated success supporting multi-regional or global clinical trials.
- Proven ability to manage contracts across diverse countries/regions (e.g., EU, UK, Asia-Pacific, Latin America, Canada, Middle East).
- Deep understanding of ICH-GCP, clinical operations, and international clinical trial processes.
- Exceptional communication, negotiation, and cross-cultural collaboration skills.
- Proficiency with global contract management tools (e.g., CTMS, eTMF, CLM systems).
Preferred Qualifications
- Experience with global phase I-IV trials across multiple therapeutic areas.
- Familiarity with FSP or hybrid outsourcing models.
- Multilingual fluency (e.g., Spanish, French, German) is a plus.
- Experience working with local affiliates or regional legal teams across major clinical research hubs.