Senior Contract Associate

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

📋 Description

• Prepare, negotiate, and finalize intricate Clinical Site Contracts, ancillary agreements, amendments, and related documentation for clinical trials.

• Execute timely and precise data entry into Clinical Business Operations systems, including the Contract Management System.

• Oversee contract budgets, budget grids, cost assessments, Fair Market Value compliance, and investigator site budgets.

• Implement contracts according to established timelines and objectives, forecasting and monitoring fully executed contract dates.

• Conduct quality checks on approved contract and budget documents and initiate signature processes.

• Act as the primary liaison among CBO, Global Clinical Operations, Legal, investigator sites, and external service providers.

• Gather and maintain country and site intelligence while preparing site-specific contract process flows.

• Review and revise contract templates and contribute to legal playbook guidance.

• Collaborate with Investigator Payment Management to ensure contracts and budgets are approved and executed.

• Inform stakeholders about legal, budgetary, contracting issues, risks, and potential delays.

• Sustain communication with site personnel and internal partners throughout the contract lifecycle.

• Attend meetings related to investigator sites, projects, CBO, and others.

• Update CBO trackers, complete filing and distribution, and maintain records in the Contract Management System.

• Provide a transition to the project/payment team following the execution of final site contractual documents.

⛳️ Requirements

• Bachelor's degree with 3 or more years of experience in clinical research site contracting and budgeting, with increasing responsibilities within a pharmaceutical company, CRO, or a relevant industry vendor.

• Alternatively, up to four years in clinical operations, preferably within the biotechnology, pharmaceutical, and/or CRO industry.

• Familiarity with Clinical Trial Agreements, budgeting, and Fair Market Value principles.

• Proficiency in Microsoft Office applications, CTMS, Contract Lifecycle Management System, Veeva, Jira, Beep/SharePoint.

• Solid understanding of ICH-GCP, pharmaceutical-related regulations, and laws.

• Good grasp of clinical trial contracting processes and relevant clinical operations practices.

• Awareness of compliance and regulatory matters in clinical research.

• Demonstrated negotiation, interpersonal, and business skills.

• Excellent planning and organizational abilities; capable of working independently in a dynamic environment with competing priorities.

• Proven track record of meeting deadlines and achieving goals.

• Strong written and verbal communication skills, including fluency in English and the local language if it is not English.

• Conflict resolution and problem-solving capabilities.

• Experience in financial, budget, cost management/analysis, accounting, and/or financial planning is preferred.

• Knowledge of intellectual property, publication, indemnification, and other standard clinical research site contract issues.

• Willingness to thrive in a fast-paced environment with time-sensitive materials.

• Ability to work effectively at all organizational levels.

• Travel: 10%.

🏝️ Benefits

• Equal opportunity employer.

• Travel: 10%.