Site Contract Analyst - Freelancers in Italy! Home-Based!
Home Based Opportunity in Italy!
Oversees administration and negotiation processes for complex site contracts that support projects within Clinical Operations on a global scale. Ensures site contract documentation is in compliance with sponsor and Company requirements. Identifies project and/or individual site contract related problems and works with internal and external team members to provide and implement solutions. Serves as technical expert across all Site Contracts functions. Trains and mentors site contracts staff and proactively identifies ways to improve internal project operations. Establishes strong working relationships with customer and internal project teams.
- Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products. Maintains and updates training material for site contract team.
- Serves as a resource to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
- Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
- Anticipates risk/benefit issues, assists with remedial action plans, and troubleshoots to resolve any concerns.
- Facilitates Contract Managers or other site contracts staff with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
- Assists in generating amended documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions.
- Creates and maintains document status reports and updates department team members on a regular basis; ensures appropriate documentation is maintained for all exceptions.
- Facilitates contract management functions with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
- Facilitates the execution of contracts by company signatories.
- Maintains contract templates and site specific files and databases.
- Assists with negotiation and preparation of contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
- Serves as communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
Performs other work-related duties as assigned, including support to other start-up functions as required at a country level. Minimal travel may be required (up to 25%).
- BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of educaiton and experience. Advanced degree preferred.
- High level of contracts management experience.
- Experience in a contract research organization, pharmaceutical, or biotechnology company preferred.
- Strong knowledge of the clinical development process and legal and contracting parameters preferred.
- Stong computor skills in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
- Excelent written/oral communication and organizational skills,attention to detail, accuracy.
- Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations.