Clinical Contracts Associate (EMEA)

Infinity Quest; Roma; In loco; EUR 42.000 - 70.000; Tempo pieno

Descrizione del lavoro

Infinity Quest is seeking a Clinical Contracts Associate to manage the preparation, negotiation, and execution of clinical contracts (including budgets) in the EMEA region with minimal supervision.

You'll adapt country and site budget templates, draft and edit contracts, and negotiate with sites while coordinating with Legal and Compliance to address indemnification, IP, confidentiality and compensation terms; ensure budgets align with protocol requirements and patient safety policies.

Competenze

• Bachelor’s degree and at least 4 years in clinical research or related field.
• Deep knowledge of clinical contracts and budgeting.
• Ability to solve complex problems and apply solutions.
• Proficiency with Word/Excel and related tools.
• Excellent communication in English.

Mansioni

• Adapt site budget templates to country and site requirements.
• Prepare and edit contracts, amendments, and change orders of medium complexity.
• Analyze documents for risk and propose mitigations.
• Negotiate with research sites under regulatory compliance.
• Ensure budgets align with protocol requirements and policies.
• Review country/site changes to consent language.
• Work independently and assist less experienced colleagues.

Conoscenze

Clinical contracts

MS Office

English proficiency

Independent work

Formazione

Bachelor's degree in relevant field

Descrizione del lavoro

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 analyses 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.