Clinical Contracts Associate (EMEA)

Clinical Contracts Associate (EMEA)
Role Summary
The Clinical Contracts Associate is responsible, under minimal management direction, for the preparation, negotiation,
and execution of clinical contracts (including budgets) and amendments in the EMEA region. This role analyzes
documents for corporate risk, engages with legal and compliance stakeholders, and negotiates directly with research
sites.
Key Responsibilities
Adapts study site budget templates to country- and site-specific requirements.
Creates, prepares, reviews, and edits contracts, work orders, amendments, modifications, and change orders of
medium complexity and risk type.
Analyzes documents to determine corporate risk and prepares alternative approaches to mitigate identified risk.
Negotiates with research sites in compliance with applicable regulations, working with Legal and other
stakeholders on contract language including indemnification, intellectual property, confidentiality, and
compensation terms.
Ensures clinical trial budgets are aligned with clinical protocol requirements and associated policies.
Reviews and approves country- and site-specific changes to Patient Informed Consents concerning injury, data
privacy, and compensation language.
Works independently with minimal guidance; acts as a resource for less experienced colleagues.
Required Qualifications
Bachelor's degree from an accredited university or college, or equivalent experience in clinical research, medical
device/pharmaceutical, or a clinical/hospital environment; minimum 4 years of related experience.
In-depth knowledge and experience in clinical contracts; ability to apply best practices and business knowledge to
improve service delivery.
Ability to solve complex problems and take a new perspective using existing solutions.
Proficiency in Microsoft Word, Excel, or equivalent software.
Effective written and verbal communication skills in English.
Ability to work independently and handle sensitive/confidential information with discretion.
Strong interpersonal skills; ability to work in a highly matrixed and geographically diverse environment.
Strong organizational skills and attention to detail; ability to multitask and meet deadlines.
Preferred Qualifications
5+ years of related experience in clinical contracting and budgeting.
General familiarity with cardiac, vascular, and/or neuromodulation technologies and clinical research processes.
General understanding of clinical study protocols including study design, procedures, and trial duration.
Experience working in a cross-division or enterprise business unit model.