Senior Specialist, Site Contracts

This is a fully remote position, open to applicants in Spain.

📋 Description

• Serve as a Subject Matter Expert on Clinical Trial Agreement processes at both the country and site levels.

• Prepare, negotiate, and finalize contracts and budgets for sites.

• Oversee the Investigator Budget and act as a primary contact for contract-related communications.

• Address negotiation challenges and escalate potential risks.

• Propel process enhancements.

• Assist in the development of Standard Operating Procedures (SOPs) and ensure templates are current.

• Collaborate and coordinate with Worldwide and external stakeholders, including sites and investigators.

• Examine and finalize Clinical Trial Agreements and related documents, ensuring they are complete and accurate.

• Analyze, review, and draft contracts for clinical research sites, investigators, and other project-related agreements.

• Negotiate and conclude clinical trial contracts and service agreements with the Worldwide Legal Department, study teams, sponsors, investigators, and clinical sites.

⛳️ Requirements

• Expertise in negotiating intricate contract terms with clinical sites and vendors.

• Comprehensive knowledge of international and local regulatory standards for clinical trials, including FDA, EMA, and ICH-GCP.

• Capability to articulate complex contract terms in a clear and concise manner.

• Leadership abilities to mentor and support junior contract specialists.

• Proficient in collaborating with legal, finance, data protection, and clinical operations teams.

• 3–4 years of experience as a Senior Site Contracts Specialist or a minimum of 5 years in Site Contract roles within the clinical research, pharmaceutical, or CRO sectors.

• Bachelor’s Degree or equivalent in business administration, finance, law, science, or a relevant field.

• Proficient in MS Word, Excel, and Outlook.

• Well-versed in ICH and GCP Guidelines, local legislation pertaining to clinical trials, and regional regulatory requirements.

• Strong knowledge of the biopharmaceutical/CRO industry and relevant local regulatory standards.

🏝️ Benefits

• Equal employment opportunities irrespective of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or any other class protected by applicable law.

• A diverse and inclusive workplace environment.

• Supportive teams and approachable leadership.

• A professional opportunity to collaborate with global stakeholders.