Clinical Site Contracts Specialist – Site Agreements, Budget Experience

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.
• Legal background (e.g. Law degree) is a plus.
• High level of contracts management experience.
• Experience in clinical research site contracts, including contract negotiations, budget development/review, and management of clinical agreements.
• 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.
• 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.

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.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• Health insurance.