Clinical Trials Contract Specialist

POSITION SUMMARY:

A Clinical Trials Contract Specialist is responsible for the development, negotiation, and management of clinical trial agreements. This role ensures compliance with regulatory requirements, institutional policies, and sponsor expectations.

The Contract Specialist works closely with study teams, Legal, Accounts Payable, and clinical site personnel to support the logistical and administrative aspects of multiple clinical trials. The position operates with oversight from the Senior Manager, Budgets & Contracts, and adheres to company policies, study protocols, SOPs, and applicable regulatory requirements.

PRIMARY RESPONSIBILITIES:

  • Support cross-functional initiatives with a focus on customer experience and business operations.
  • Collaborate with Legal, study teams, vendors, and sites to address contract concerns and ensure alignment for execution.
  • Draft, review, and negotiate Non-Disclosure Agreements (NDAs), Clinical Trial Agreements (CTAs), including Clinical Study Agreements (CSAs), Statements of Work (SOWs), Investigator Sponsored Agreements (ISAs), amendments, and related documents.
  • Ensure all agreements comply with FDA regulations, institutional policies, and ethical standards.
  • Serve as the primary point of contact for contract-related inquiries from internal and external stakeholders.
  • Maintain accurate and up-to-date contract files, databases, and tracking systems.
  • Monitor contract milestones and deadlines to ensure timely completion and avoid delays.
  • Provide guidance to investigators and study teams on contract-related matters.
  • Identify and mitigate risks associated with clinical trial contracts.
  • Participate in continuous improvement initiatives related to contract processes.
  • Performs other duties and special projects as assigned.

QUALIFICATIONS:

  • Bachelor’s degree required; scientific discipline preferred.
  • Minimum of 5 years of experience working on clinical studies in biopharma, diagnostics, or medical device fields.
  • At least 3 years of experience negotiating investigator site agreements.

KNOWLEDGE, SKILLS, AND ABILITIES:

Technical:

  • Familiarity with clinical Electronic Data Capture (EDC) systems.
  • Strong understanding of SOPs, ICH-GCP, and FDA regulations.
  • Proficiency in Google Workspace (gSuite), MS Word, Excel, and PowerPoint.
  • Experience with Salesforce, contract management, and enterprise systems preferred.
  • Strong analytical skills and ability to develop solutions to contractual issues.

Behavioral:

  • Excellent negotiation, communication, and interpersonal skills.
  • Ability to manage a high-volume workload and meet project-specific deadlines.
  • Flexibility and independence in managing contract negotiations.
  • Collaborative mindset to interact with internal and external stakeholders.

Preferred:

  • Experience with vendor management.
  • Experience with Investigator Sponsored Agreements (ISAs).

PHYSICAL DEMANDS & WORK ENVIRONMENT:

Duties are typically performed remotely.
This position requires the use of a computer keyboard, communication via phone, and reading printed/digital materials.
Duties may occasionally require work outside normal business hours, including evenings and weekends.

Travel Requirement:

☒ No

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