Senior Site Contracts Specialist – Sponsor Dedicated

Role Overview

• May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Produces site-specific contracts from country clinical trial agreement (CTA) template.
• Reviews and owns site-specific contracts from country template.
• Submits proposed CTA and investigator budget for site review.
• Negotiates budget and contract with site and 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.
• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
• Works closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.
• Works closely with SSU lead, Clinical Operations and Finance to validate the load of departmental budgets and corresponding backlog.
• Identifies possible contract or process operational risk and proactively works within the team to provide solutions.
• Establishes strong working relationships with SSU lead, customer and internal project teams.
• Escalates deviations to department leadership and/or Site Contract Service Center and/or Legal Department.
• Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• 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.
• Maintains and actively supports review and development of contract templates, budget templates and site specific files and databases.
• Serves as key 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.
• 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.

Requirements

• BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
• Advanced degree preferred
• Moderate contracts management experience that includes experience in a contract research organization or pharmaceutical industry
• 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 and to remain flexible and adaptable in stressful situations
• 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
• Strong organizational skills with proven ability to handle multiple projects
• Excellent communication, presentation and interpersonal skills
• Quality-driven in all managed activities
• Fluency in English, French and Dutch
• Strong negotiating skills
• Strong problem-solving skills
• Ability to mentor and motivate more junior staff
• Demonstrate an ability to provide quality feedback and guidance to peers.

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.