Contract Specialist

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
• Produces site-specific contracts from country template
• Provides 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
• 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

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
• Experience with contracts and budgets
• Experienced in contract writing and reviewing
• Strong computer skills in Microsoft Office Suite
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
• Fluency in German and proficient in English

Tech Stack

• Google Cloud Platform

Benefits

• supportive and engaged line management
• technical and therapeutic area training
• peer recognition and total rewards program