Principal Specialist, Site Contracts

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

📋 Description

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

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

• Oversee the Investigator Budget.

• Act as a primary point of contact for communications related to contracts.

• Address negotiation challenges and escalate potential risks.

• Promote process enhancements.

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

• Collaborate and liaise with global stakeholders and external parties, including sites and investigators.

• Review and finalize Clinical Trial Agreements and related documents, ensuring completeness and accuracy.

⛳️ Requirements

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

• Comprehensive knowledge of both international and local regulatory requirements 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.

• Strong collaborative skills to work effectively with legal, finance, data protection, and clinical operations teams.

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

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

• Proficiency in MS Word, Excel, and Outlook.

• Familiarity with ICH and GCP Guidelines.

• Understanding of local country legislation and regulatory requirements pertaining to clinical trials.

🏝️ Benefits

• A diverse and inclusive work environment.

• Supportive and cohesive team dynamics.

• Accessible and hands-on leadership.

• Equal employment opportunities for all.

• An employee experience centered on respect and inclusion.