Overview
As a Senior Contract Associate, you drive the drafting, negotiation, and finalization of complex Clinical Site Contracts for clinical trials. You will serve as the liaison between CBO, GCO, Legal, sites, and external providers to ensure timely, compliant contracts and accurate budgeting. You’ll manage contract lifecycle data in CMS, monitor milestones, and proactively flag risks to keep study timelines on track. This role places you at the intersection of operations, law, and science in a fast-paced environment. Your work supports rapid, compliant site engagements that advance cancer research.
Verantwortungsbereiche
- Prepare, negotiate, and finalize clinical trial agreements, ancillary agreements, and amendments with study sites
- Execute contracts against planned timelines and targets; manage budget grid and ensure cost calculations align with protocols
- Perform QC of final contracts and budgets and initiate signature process
- Maintain CMS records and ensure on-time delivery of final contracts
- Act as primary contact between CBO, GCO, Legal, sites, and external providers; communicate issues per guidelines
- Collect site/country intelligence and prepare contract process flows; forecast and track fully executed contract dates
- Liaise with CM and BeiGene legal on contract templates and playbooks; ensure regulatory and policy alignment
- Ensure investigator contracts are reviewed and approved by legal or delegates; obtain approvals before execution
- Translate contract language as needed; maintain ongoing communication with site personnel and internal partners
- Escalate issues and participate in meetings; update trackers and distribute contract documents
- Provide handoffs to project/payment teams after execution of final site contracts
Zentrale Anforderungen
- Bachelor degree with 3+ years in clinical research site contracting and budgeting or up to 4 years in clinical operations
- Experience with Clinical Trial Agreements and budgeting; knowledge of Fair Market Value
- Strong negotiation, interpersonal, and business skills
- Excellent planning, organizational abilities, and independence in a dynamic environment with competing priorities
- Fluent written and verbal communication in English; ability to communicate in local language if applicable
- Strong data-driven decision-making ability; familiarity with ICH-GCP and regulatory requirements
- Ability to work in fast-paced environments with time-sensitive material
- Willingness to travel (10%)
- Experience with financial planning/cost management is a plus
- Knowledge of IP, Publication, and Indemnification issues in site contracts
- negotiation
- interpersonal skills
- proactivity
- CTMS
- Contract Lifecycle Management System
- Veeva
Senior Contract Associate in Heilbronn Arbeitgeber: BeiGene
BeOne ist ein hervorragender Arbeitgeber, der eine dynamische und unterstützende Arbeitsumgebung bietet, in der Mitarbeiter ihre Fähigkeiten weiterentwickeln und an bedeutenden Projekten zur Bekämpfung von Krebs mitwirken können. Mit einem klaren Fokus auf kontinuierliches Lernen und Entwicklung fördert BeOne eine Kultur der Zusammenarbeit und Innovation, während die strategische Lage in Deutschland den Zugang zu einem breiten Netzwerk von Fachleuten und Ressourcen ermöglicht. Die Möglichkeit, an der Gestaltung von Schulungsprogrammen für neue Produkte und Marktstrategien mitzuwirken, macht diese Position besonders attraktiv für engagierte Fachkräfte.
