Clinical Contracts Administrator (EDG-2026019)

Role Summary

The Clinical Contracts Administrator supports the lifecycle management of clinical trial–related agreements for a biotechnology company conducting sponsored clinical research. This entry-level role provides hands-on exposure to biotech clinical development, supporting Phase I–III studies by assisting with site and vendor contracting activities to ensure timely study start-up and compliance with internal policies and regulatory requirements.

Responsibilities

• Support the preparation, review, and execution of clinical trial agreements, including:
  • Confidentiality Disclosure Agreements (CDAs)
  • Clinical Trial Agreements (CTAs)
  • Vendor and Service Provider Agreements (CROs, central labs, imaging vendors, etc.)
  • Contract amendments and change orders
• Assist with site start-up activities by tracking contract status, milestones, and timelines to support study activation.
• Coordinate contract review and signature routing with internal stakeholders including Clinical Operations, Legal, Finance, Regulatory, and external investigational sites and vendors.
• Maintain accurate contract trackers and document repositories in contract lifecycle management (CLM) and trial master file (TMF) systems.
• Support budget review processes to ensure alignment between approved clinical budgets and contract terms.
• Assist with purchase order (PO) creation and documentation in collaboration with Finance and Clinical Operations.
• Communicate professionally with clinical sites, CROs, and vendors regarding contract status, outstanding items, and next steps.
• Ensure contracts and supporting documentation meet biotech sponsor requirements and are inspection-ready.
• Contribute to process improvements, standard operating procedures (SOPs), and the maintenance of standardized contract templates.

Qualifications

• 0–2 years of experience in clinical research, clinical operations, contracts administration, or a related biotech or pharmaceutical environment
• Internship, co-op, or administrative experience within a biotech, pharmaceutical, CRO, or clinical research setting is a plus
• Strong organizational skills and attention to detail in a regulated environment
• Ability to manage multiple studies, timelines, and priorities
• Clear and professional written and verbal communication skills
• Proficiency in Microsoft Office (Word, Excel, Outlook); experience with CLM or CTMS systems is a plus
• Ability to collaborate cross-functionally in a fast-paced biotech setting
• Eagerness to learn clinical trial contracting, budgeting, and regulatory requirement
• Basic understanding of biotech drug development and clinical trial phases (Phase I–III)
• Familiarity with ICH-GCP, FDA regulations, and sponsor oversight responsibilities
• Exposure to TMF systems and inspection readiness concepts

Education

• Bachelor’s degree in Life Sciences, Biotechnology, Business Administration, Healthcare Administration, or a related field