Site Contracts Specialist II – German

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

📋 Description

• Oversee the contract management procedures related to protocol, informed consent, institutional, investigator, vendor, consultant, and customer agreement documents at the project level.

• With guidance, lead multi-country projects that involve the negotiation and preparation of contracts, budgets, and associated documentation for industry-sponsored clinical trials.

• Assist SSUL in finalizing country template contracts and budgets.

• Create site-specific contracts derived from country templates.

• Aid in the submission and negotiation of proposed contracts and budgets with sites, the Site Contracts Service Centre, SSUL, and sponsors.

• Conduct quality control and organize the execution and archiving of clinical trial agreements, along with metadata capture.

• Review contracts for completeness and accuracy, documenting any necessary corrections.

• Support business development and represent site contracts/Site Start-Up during internal or client meetings.

• Proactively manage ongoing contract-related issues, follow up on unresolved matters, and produce amended contract or budget documents.

• Prepare documentation for contract management and enhance internal processes related to contracts and proposals.

• Monitor country/site contracting timelines and milestone progress within the SSU tracking system.

• Collaborate with legal, finance, clinical operations, vendors, sponsors, and other internal and external stakeholders.

• Facilitate the execution of contracts by company signatories.

• Maintain contract templates, site-specific files, databases, and training resources.

• Train and mentor less experienced personnel while providing functional guidance.

• Communicate contract statuses and outstanding issues while preparing relevant correspondence.

• Monitor basic financial aspects of projects, including contract hours/tasks, and escalate any discrepancies.

• Adhere to SOPs, Work Instructions, training records, and timesheet requirements.

⛳️ Requirements

• BA/BS degree in Business Administration, Public Administration, Public Health, or a related field, or an equivalent combination of education and experience.

• An advanced degree is preferred.

• Significant experience in contract management is required.

• Experience in a contract research organization or the pharmaceutical industry is essential.

• Strong understanding of the clinical development process along with legal and contracting parameters.

• Proficient in Microsoft Office Suite.

• Excellent comprehension of the clinical trial process across Phases II-IV and ICH GCP.

• Good knowledge of clinical protocols and related study specifications.

• Thorough understanding of clinical trial start-up processes.

• Project management experience in a dynamic environment is necessary.

• Effective vendor management skills.

• Strong negotiation and problem-solving abilities.

• Capability to mentor, lead, and motivate junior staff members.

• Ability to provide constructive feedback and guidance to colleagues.

• Capacity to contribute to a training and Quality Assurance plan within SSU and revise SOPs/WI.

• Exceptional written and verbal communication, presentation, documentation, interpersonal, organizational, and teamwork skills.

• Ability to manage competing priorities while remaining flexible and adaptable in high-pressure situations.

• Quality-focused approach.

• Proficiency in the German language as indicated by the job title.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Recognition from peers.

• Total rewards program.

• Inclusive company culture.

• Chance to collaborate with colleagues globally.

• Reasonable accommodations, when applicable, under the Americans with Disabilities Act.