Site Contracts Specialist II/Sr – Sponsor Dedicated

• Administer all contract management processes, including coordination of protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at project level
• Lead, with supervision, multi-country projects including negotiating and preparing contracts, budgets, and related documents for industry-sponsored clinical trials
• Support agreement on country template contracts and budgets and produce site-specific contracts
• Support submissions for proposed contracts and budgets for sites
• Negotiate budgets and contracts with sites through the Site Contracts Service Centre and SSUL with sponsors until issue resolution
• Perform quality control and arrange execution and archival of CTAs, including metadata capture
• Review contracts for completeness and accuracy and ensure corrections are made and documented
• Support business development and represent site contracts/Site Start-Up at internal or customer meetings
• Actively manage ongoing contract issues with Contract Managers and team members and follow up on outstanding issues
• Generate amended contract and/or budget documents and streamline contract, proposal, and internal processes
• Track milestone progress in the agreed SSU tracking system in real time and comply with country/site contracting timelines
• Collaborate with legal, finance, and clinical operations departments on legal and budgetary issues
• Facilitate execution of contracts by company signatories
• Maintain contract templates, site-specific files, and databases
• Train and mentor less experienced staff and maintain departmental training materials
• Act as communication liaison between site contracts staff and internal and external customers
• Communicate contract statuses and pending issues and prepare correspondence
• Monitor basic project financial aspects and contract hours/tasks and escalate discrepancies
• Review and comply with SOPs and WIs, update training records, and ensure timesheet compliance

• BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience
• Advanced degree preferred
• High level of contracts management experience
• Experience in a contract research organization or pharmaceutical industry essential
• Strong knowledge of the clinical development process and legal and contracting parameters
• Strong computer skills in Microsoft Office Suite
• Ability to manage challenging priorities and remain flexible and adaptable in stressful situations
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
• Good understanding of clinical protocols and associated study specifications
• Excellent understanding of clinical trial start-up processes
• Project management experience in a fast-paced environment
• Good vendor management skills
• Excellent written/oral communication, presentation, documentation, interpersonal, and team-orientation skills
• Strong organizational skills with proven ability to handle multiple projects
• Quality-driven approach, strong negotiating skills, and strong problem-solving skills
• Ability to mentor, lead, and motivate more junior staff
• Ability to provide quality feedback and guidance to peers
• Ability to contribute to a training and Quality assurance plan within SSU and update SOPs/WIs

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture
• Reasonable accommodations when appropriate, in compliance with the Americans with Disabilities Act