Site Contracts Specialist – Level II or Senior Level

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

📋 Description

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

• Lead, under supervision, multi-country initiatives that involve the negotiation and preparation of contracts, budgets, and related documents for industry-sponsored clinical trials.

• Assist SSUL in finalizing country template contracts and budgets, and create site-specific contracts.

• Aid in submissions and negotiations for proposed site contracts and budgets with sites, SSUL, and sponsors.

• Conduct quality control, facilitate the execution of CTAs, archive documents, and capture metadata.

• Evaluate contracts for completeness and precision, documenting any corrections made.

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

• Proactively manage ongoing contract issues and follow up on unresolved matters.

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

• Monitor contracting milestones against projected country/site timelines in the designated SSU tracking system.

• Collaborate with legal, finance, clinical operations, and external stakeholders concerning legal and budgetary matters.

• Facilitate contract execution by company signatories.

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

• Train and mentor less experienced staff, ensuring training materials are up to date.

• Act as a communication liaison regarding contract statuses and pending issues, preparing necessary correspondence.

• Monitor basic project financial aspects and contract hours/tasks, escalating any discrepancies as needed.

• Review and adhere to SOPs and WIs, maintain training records, and ensure compliance with timesheet requirements.

⛳️ Requirements

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

• Advanced degree is preferred.

• Extensive experience in contract management is required.

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

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

• Proficiency in Microsoft Office Suite is required.

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

• Solid understanding of clinical protocols and associated study specifications.

• Comprehensive understanding of clinical trial start-up processes.

• Project management experience in a dynamic environment is preferred.

• Good vendor management skills are necessary.

• Exceptional written/oral communication, presentation, documentation, interpersonal, and team-oriented skills.

• Strong organizational abilities with a proven capability to manage multiple projects simultaneously.

• Quality-driven mindset, strong negotiation skills, and effective problem-solving abilities.

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

• Ability to provide constructive feedback and guidance to peers.

• Capability to contribute to a training and quality assurance plan within SSU and update SOPs/WIs.

• Equivalent experience, skills, and/or education will also be considered.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition within the team.

• Comprehensive total rewards program.

• Inclusive workplace culture.

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