"Alerted.org

Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

The Sr. Clinical Trial Contracts Specialist will be responsible for the development, negotiation, and management of global clinical trial agreements and site budgets. This role ensures compliance with regulatory requirements, company policies, SOPs and study protocols. This role will support study teams through the generation of new contracts and amendments throughout the clinical study lifecycle. The Sr. Clinical Trial Contracts Specialist will coordinate review/input internally across Legal, Compliance, Finance and Clinical, and they will interact heavily with healthcare professionals and other clinical vendors. Clinical research is the top priority for Cordis, and this role will be directly involved in the success of the organization in improving patient care and coordinating with clinical sites.

Key Responsibilities

+ Draft, review, and finalize contract templates including Non-Disclosure Agreements (NDAs), Clinical Trial Agreements (CTAs), including Statements of Work (SOWs), amendments, budgets and related documents

+ Negotiate contract terms with external partners e.g. sites, vendors, etc.

+ Provide oversight of contract and budget negotiations across all Selution DEB clinical studies

+ Facilitate review of contracts and budgets between internal and external parties to address contract questions and ensure alignment for execution

+ As needed, consult with multiple parties, including Clinical study teams, Legal, Compliance, Finance for review and input on contract and budgets

+ Establish a review process for contracts and budgets and identify stakeholders

+ Ensure agreements comply with FDA regulations or country specific regulations, company policies, and ethical standards

+ Work closely with Clinical study team and Finance to develop and maintain standardized clinical trial budget templates.

+ Create and amend budgets to ensure clinical trial budgets support protocol implementation, and clinical site requirements (i.e. institutional fees, procedure and administrative costs, study team time and effort, etc.).

+ Adhere to company defined budget limits and ensure compliance with Fair Market Value (FMV) principals throughout negotiations and escalate as necessary

+ Manage communication across all stakeholders and serve as the primary point of contact for contract and budget-related inquiries internally and externally

+ Lead cross-functional alignment meetings for high-priority contract negotiations to keep timelines on track and ensure shared expectations

+ Act as Subject Matter Expert for clinical contract language and budget justifications during internal audits, external inspections, or regulatory queries

+ Maintain accurate and up-to-date files and tracking systems for contracts and budgets

+ Create/maintain guidelines, training programs, policies and procedures related to Clinical trial contracts and budgets

+ Escalate any identified risks/concerns during clinical trial contract and budget negotiations

+ Complete periodic quality reviews with clinical study teams of all study contract documents

+ Track contract cycle metrics (e.g., average negotiation turnaround time, revisions per contract, budget escalations, and report quarterly to leadership

Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, Good Clinical Practices, ISO 14155, Regulatory Agency requirements

Qualifications

Require Skills

+ Bachelor’s degree required; scientific discipline preferred.

+ Minimum 5 years of clinical study experience

+ Minimum 3 years of experience negotiating and managing clinical contracts and budgets globally

+ Knowledge of International clinical regulations

+ Precise, Rigorous, Detail-Oriented

+ Ability to manage and prioritize high-volume workload to meet project-specific deadlines

+ Strong project management skills to facilitate review and input across multiple functions

+ Ability to take independent decisions, but ensuring a collaborative mindset to interact with internal and external stakeholders

+ Strong writing skills and ability to process complex documents

+ Capable of working across multiple time zones

+ Proven ability and dependability to work remotely

Preferred Qualifications 1

Pay / Compensation

The expected pre-tax pay rate for this position is $82,250 - $114,400 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming

JOIN OUR TALENT COMMUNITY

Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests.

**Job Locations** _US-CA-Irvine_

**ID** _2025-9250_

**Category** _Clinical_

**Position Type** _Regular Full-Time_

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact [email protected]