Site Contracts Specialist, Polish Required

Role Overview

• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level
• May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials
• Provides support to SSUL to agree on country template contract and budget
• Produces site-specific contracts from country template
• Provide support in submissions for proposed contract and budget for site
• Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata
• Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented
• Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings
• Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues
• Support in generating amended contract and/or budget 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
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time
• Collaborates 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
• 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
• Acts as a 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
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance

Requirements

• 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
• Customer focused and ability to manage challenging priorities
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
• Good understanding 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 skills as well as strong team-orientation
• Strong organizational skills with proven ability to handle multiple projects
• Strong negotiating skills
• Strong problem-solving skills
• Ability to mentor, lead and motivate more junior staff

Tech Stack

• Google Cloud Platform

Benefits

• We are passionate about developing our people, through career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Committed to building an inclusive culture