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