Site Contracts Specialist

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

📋 Description

• Oversee multi-national projects which include negotiating and preparing contracts, budgets, and associated documentation for industry-sponsored clinical trials.

• Create and review site-specific agreements derived from country clinical trial agreement templates.

• Submit suggested CTAs and investigator budgets for site evaluation.

• Negotiate budgets and contracts with sites, the Site Contracts Service Centre, SSUL, and sponsors.

• Conduct quality control and manage the execution and archiving of CTAs and related metadata.

• Oversee project-level contract management processes and coordinate associated agreements.

• Generate revised contract and budget documents while optimizing contract, proposal, and internal workflows.

• Collaborate with the Site Contract Service Center and Legal to ensure site contracts align with the terms of the sponsor master service agreement.

• Partner with SSU lead, Clinical Operations, and Finance to confirm departmental budgets and address backlog.

• Identify operational risks, propose solutions, and escalate any deviations.

• Assist in business development and represent site contracts/SSU at internal or client meetings.

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

• Work together with legal, finance, and clinical operations teams on legal and budgetary matters.

• Maintain contract templates, budget frameworks, site-specific files, and databases.

• Act as a communication liaison regarding contract statuses and outstanding issues.

• Train and guide less experienced staff while maintaining updated training materials.

• Facilitate contract execution by company signatories.

• Oversee project financial aspects and contract hours/tasks, addressing discrepancies as needed.

• Review and adhere to SOPs and WIs while keeping training records current.

⛳️ Requirements

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

• Advanced degree is preferred.

• Moderate experience in contract management, particularly within a contract research organization or the pharmaceutical industry.

• Management experience is preferred.

• In-depth knowledge of the clinical development process along with legal and contracting parameters.

• Proficient computer skills in the Microsoft Office Suite.

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

• Good understanding of clinical protocols and related study specifications.

• Strong grasp of clinical trial start-up processes.

• Experience in project management within a fast-paced environment.

• Good vendor management capabilities.

• Strong organizational skills with a proven ability to manage multiple projects simultaneously.

• Exceptional communication, presentation, and interpersonal skills.

• Strong negotiation skills.

• Excellent problem-solving abilities.

• Capability to mentor and motivate junior staff.

• Ability to provide constructive feedback and guidance to peers.

• Capacity to contribute to a training and Quality Assurance plan within SSU and update SOPs/WIs.

• Equivalent education, skills, and/or experience may be taken into account.

• Ability to adhere to SOPs, WIs, training records, and timesheet requirements.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition initiatives.

• Total rewards program.

• Inclusive workplace culture.

• Opportunity to collaborate with colleagues globally.