This is a fully remote position, open to applicants in Germany, +1 more country.

📋 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 key point of contact for all contract-related communications.

• Address negotiation challenges, escalate risks, foster process enhancements, aid in the development of Standard Operating Procedures (SOPs), and ensure templates are current.

• Collaborate and communicate with Worldwide stakeholders as well as external entities such as sites and investigators.

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

⛳️ Requirements

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

• Comprehensive knowledge of international and local regulatory frameworks governing clinical trials, including FDA, EMA, and ICH-GCP guidelines.

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

• Leadership abilities to mentor and support junior contract specialists.

• Proficient in collaborating 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 of Site Contract experience within the clinical research, pharmaceutical, or CRO sectors.

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

• Proficiency in MS Word, Excel, and Outlook.

• Familiarity with ICH and GCP Guidelines, local legislation for clinical trials, and regional regulatory requirements.

🏝️ Benefits

• Equal employment opportunities without regard to 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.