Senior Clinical Trial Associate (Contract)

Location: Remote (East Coast Preferred | Boston area ideal)

Duration: Through December 31, 2026, with strong likelihood of extension

Overview

We are seeking an experienced Senior Clinical Trial Associate to join a growing Clinical Operations team supporting a Phase 2 obesity program at a clinical-stage biotechnology company. This individual will play a key role in supporting a fast-paced, global clinical trial and helping drive operational excellence as the program advances into its next stage of development.

This position is best suited for someone who thrives in a dynamic biotech environment, is highly organized, and has extensive experience supporting study startup and ongoing trial execution. The successful candidate will be comfortable working cross-functionally with internal stakeholders, CRO partners, and vendors while managing multiple priorities.

Key Responsibilities

• Support the day-to-day operational execution of global clinical studies from startup through closeout.
• Lead and coordinate study startup activities, including CRO onboarding and vendor engagement.
• Assist with Trial Master File (TMF) setup, maintenance, and inspection readiness.
• Partner closely with Clinical Trial Managers and cross-functional teams to ensure study milestones are achieved.
• Track study deliverables, action items, and timelines while proactively identifying and resolving operational issues.
• Coordinate study documentation, essential documents, and regulatory deliverables.
• Facilitate communication between internal teams and external CROs to ensure seamless study execution.
• Support additional early- or mid-stage clinical programs as business needs evolve.
• Contribute to process improvements and operational best practices across Clinical Operations.

Qualifications

• Bachelor’s degree in a life science or related discipline.
• Approximately 5-7+ years of Clinical Operations experience, including significant experience as a Clinical Trial Associate within a biotechnology or pharmaceutical company.
• Strong experience supporting study startup activities, including CRO selection/onboarding and vendor management.
• Demonstrated experience establishing and maintaining Trial Master Files (TMF) in accordance with GCP.
• Experience supporting Phase 1 and/or Phase 2 clinical studies.
• Ability to work independently in a fast-paced, evolving biotech environment with minimal oversight.
• Exceptional organizational skills with strong attention to detail and the ability to manage multiple priorities simultaneously.
• Excellent communication and collaboration skills, with experience working across cross-functional teams.
• Experience in obesity or metabolic disease programs is preferred but not required.

Preferred Experience

• Clinical-stage biotechnology experience.
• Experience supporting global clinical trials.
• Familiarity with electronic TMF systems and clinical trial management platforms.
• Ability to adapt quickly as programs evolve and priorities shift.

Location

This is a fully remote position. Candidates located on the East Coast are strongly preferred to facilitate collaboration across global time zones. Boston-area candidates are ideal and may have opportunities to participate in occasional in-person team meetings or company events.