Senior Site Contracts Specialist

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

📋 Description

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

• Create and evaluate site-specific contracts derived from country clinical trial agreement templates.

• Present proposed CTAs and investigator budgets for site assessment.

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

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

• Manage contract administration processes and coordinate relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents.

• Generate revised contract and budget documents and prepare project contract management paperwork.

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

• Work alongside SSU lead, Clinical Operations, and Finance to ensure departmental budgets and backlog are validated.

• Identify risks related to contracts or processes and devise solutions; escalate deviations as necessary.

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

• Monitor country/site contracting milestones and ensure compliance with projected timelines using the SSU tracking system.

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

• Maintain templates for contracts, budgets, site-specific files, and databases.

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

• Mentor and train less experienced staff while maintaining training documentation.

• Engage in discussions regarding company objectives, departmental goals, and project targets.

• Facilitate contract execution by company signatories.

• Monitor the financial aspects of projects and contract hours/tasks; escalate any discrepancies.

• Review and adhere to SOPs and WIs, update training records, and ensure compliance with timesheets.

⛳️ Requirements

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

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

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

• Proficient in Microsoft Office Suite.

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

• Familiarity with clinical protocols and associated study specifications.

• Strong grasp of clinical trial start-up processes.

• Experience in project management within a dynamic environment.

• Proficient vendor management skills.

• Exceptional organizational abilities with a proven track record of managing multiple projects.

• Outstanding communication, presentation, and interpersonal skills.

• Quality-focused in all managed activities.

• Strong negotiation and problem-solving abilities.

• Capability to mentor and inspire junior staff.

• Ability to offer constructive feedback and guidance to peers.

• Competence to contribute to a training and Quality Assurance plan within SSU and update SOPs/WI.

• Advanced degree is preferred.

• Management experience is preferred.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Potential to earn commissions/bonuses based on both company and individual performance.

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations, when appropriate.