Senior Site Contracts Specialist – Sponsor Dedicated

Responsibilities

• 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.
• Admins 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.

Core Competencies

Demonstrates expertise in contract management and negotiation within the clinical trial landscape, ensuring compliance with legal and regulatory standards while effectively managing multiple projects. Proficient in fostering strong relationships with internal and external stakeholders to facilitate successful clinical trial operations.