Senior Contracts Analyst, Clinical Research - 259703

Medix™; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Medix is seeking a Senior Contracts Analyst to draft, review, and negotiate complex clinical trial and research agreements across therapeutic areas. You will support a centralized operations function and help ensure regulatory compliance, operational efficiency, and strong relationships with industry and academic partners.

You will manage intricate terms such as IP, payment structures, publication rights, indemnification, and data ownership, while coordinating with investigators and study teams

Qualifications

• Bachelor’s degree in science, healthcare, research, business administration, or related field.
• Minimum of four years of grant and/or contract administration experience.
• Experience drafting, negotiating, and executing contracts.
• Working knowledge of standard contract provisions, including confidentiality, IP, and data ownership.

Responsibilities

• Draft, review, and negotiate complex clinical trial and clinical study agreements, as well as confidentiality and disclosure agreements.
• Manage agreements with terms such as intellectual property, payment structures, publication rights, subject injury, insurance, indemnification, amendments, and dispute resolution.
• Negotiate mutually acceptable terms with pharmaceutical and biotechnology companies, academic medical centers, site networks, private industry partners, foundations, and non-profit organizations.
• Ensure all negotiated terms comply with federal and state laws, institutional policies, internal processes, and sponsor or funder requirements.
• Collaborate with investigators, research teams, and other stakeholders throughout the negotiation process.
• Maintain target turnaround times while providing clear communication to study teams.
• Stay current on evolving regulatory, governmental, and funding agency requirements.

Skills

Contract drafting

Contract negotiation

Regulatory compliance

Attention to detail

Project management

Interpersonal skills

Microsoft Office

Education

Bachelor’s degree in science/healthcare/research/business

SOCRA certification

Tools

Microsoft Office

Job description

The Senior Contracts Analyst supports a large, complex clinical research program by drafting and negotiating agreements for clinical trials and research studies across multiple therapeutic areas. This role sits within a centralized clinical research operations function and plays a critical part in ensuring regulatory compliance, operational efficiency, and strong relationships with industry and academic partners.

The Senior Contracts Analyst is responsible for managing complex contract negotiations, maintaining awareness of regulatory and policy changes, and ensuring agreements align with institutional, sponsor, and governmental requirements.

Duties and Responsibilities:

• Draft, review, and negotiate complex clinical trial and clinical study agreements, as well as confidentiality and disclosure agreements.
• Manage agreements that include intricate contractual terms such as intellectual property, payment structures, publication rights, subject injury, insurance, indemnification, amendments, and dispute resolution.
• Negotiate mutually acceptable terms with pharmaceutical and biotechnology companies, academic medical centers, site networks, private industry partners, foundations, and non-profit organizations using a variety of negotiation strategies.
• Ensure all negotiated terms comply with federal and state laws, institutional policies, internal processes, and sponsor or funder requirements.
• Collaborate closely with physician investigators, research teams, departmental administrators, and other stakeholders throughout the negotiation process.
• Maintain target turnaround times while providing transparency and clear communication to study teams.
• Partner with sponsored programs and contracts colleagues to ensure consistency in contract language and interpretation.
• Maintain complete, accurate, and current agreement files of record.
• Perform other related duties as assigned.
• Stay current on evolving regulatory, governmental, and funding agency requirements.
• Monitor changes in institutional and funder policies and practices that may affect contract terms or processes.
• Evaluate the impact of regulatory or policy changes and recommend updates to internal procedures as needed.

Minimum Qualifications:

• Bachelor’s degree in science, healthcare, research, business administration, or a related field
• Additional relevant experience may substitute for degree requirements
• Minimum of four years of experience in grant and/or contract administration
• Demonstrated ability to manage a high-volume workload with competing priorities
• High attention to detail
• Experience drafting, negotiating, and executing contracts
• Working knowledge of standard contract provisions, including confidentiality, intellectual property, and data ownership
• Strong interpersonal and customer service skills
• Proficiency with Microsoft Office applications

Preferred Qualifications:

• Experience with the clinical trial start-up process and full study lifecycle
• SOCRA certififcation
• Familiarity with various sponsor types and their differing requirements
• Knowledge of federal regulations governing research funding, including Uniform Guidance
• Understanding of federal acquisition processes and Federal Acquisition Regulations (FAR)