Senior Site Contracts Specialist, Romania, Finland

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

📋 Description

• Oversee the preparation, negotiation, finalization, and execution of Clinical Trial Agreements, site agreements, amendments, ancillary agreements, and related budgets.

• Create country-specific contract templates, contract and budget plans, investigator grant budgets, and other necessary documentation to support clinical trials.

• Negotiate intricate contract language and study budgets with designated sites.

• Efficiently address contracting issues and escalate requests that fall outside of preapproved parameters.

• Collaborate with sponsors, clinical sites, investigators, Legal, Data Privacy, regulatory colleagues, and study teams.

• Identify contracting risks and non-responsive sites, develop strategies for mitigation, and escalate issues as needed.

• Ensure that agreements and budgets are thorough, accurate, compliant, and undergo quality checks prior to signature, distribution, and filing.

• Monitor negotiation status, contracting timelines, risks, and priorities through precise, real-time tracking and effective communication with stakeholders.

• Serve as a site contracts authority on assigned projects.

• Assist with contract templates, master budgets, TMF structure, contracting strategies, and process improvement initiatives.

⛳️ Requirements

• A bachelor's degree or equivalent in business administration, finance, science, or a related discipline.

• 3 to 5 years of experience as a Contract Specialist within the clinical research, pharmaceutical, or CRO sectors.

• Exceptional proficiency in English, both written and verbal.

• Strong expertise in negotiating complex clinical site contracts and budgets.

• Experience in resolving contract issues and identifying as well as mitigating contracting risks.

• Familiarity with ICH and GCP Guidelines.

• Knowledge of local clinical trial legislation and regulatory requirements.

• Awareness of pertinent international regulatory standards.

• Solid understanding of clinical trial budgeting and financial principles.

• Capability to review costs, negotiate budgets, and interpret financial data.

• Excellent communication, problem-solving, analytical, and teamwork skills.

• Ability to articulate complex contract terms clearly and work effectively with cross-functional stakeholders.

• Strong project management and time management abilities.

• Skill in prioritizing competing demands, managing multiple site contracts, meeting deadlines, and ensuring accuracy under pressure.

• Proficiency in MS Word, Excel, Outlook, and contract management tools.

• Working knowledge of legal terminology and principles applicable to clinical trial contracts.

🏝️ Benefits

• A collaborative and inclusive work environment.

• Opportunities for growth and learning.

• The chance to contribute to impactful clinical research and life-changing therapies.