Clinical Project Manager

Elixir Associates LTD; United States; Remote; USD 120,000 - 160,000; Full time

Benefits offered by this job

Fully remote

Competitive compensation

Job summary

Elixir Associates LTD is seeking a Clinical Project Manager with ophthalmology study experience to own studies from start-up through close-out. This role offers genuine ownership within a collaborative CRO, with direct visibility to senior leadership and opportunities to shape study delivery.

You will act as the main sponsor contact, oversee timelines and budgets, manage vendors, mitigate risks, and ensure TMF readiness while keeping sponsors informed through regular reporting.

Qualifications

• 5+ years of relevant clinical research experience.
• Strong knowledge of GCP, ISO standards and FDA regulations.
• Ophthalmology study experience; drug or device.

Responsibilities

• Act as the main sponsor contact, advising on study strategy and delivery.
• Own delivery from start-up to close-out, including timelines, budgets and resourcing.
• Manage vendors and day-to-day execution.
• Anticipate risks and enrollment challenges and mitigate before timelines are affected.
• Keep the TMF inspection-ready and ensure regulatory compliance.
• Provide regular reporting and forecasts to sponsors and senior leadership.
• Mentor junior colleagues and contribute to proposals.

Skills

Clinical research experience

GCP knowledge

ISO FDA regulations

Ophthalmology study experience

Communication skills

Job description

Clinical Project Manager - Ophthalmology - Remote (US)

Company:

Elixir Associates is pleased to be partnered with a growing, full-service CRO supporting sponsors across pharma, medical device and cell & gene therapy. They have recently won new business across all three areas and are expanding their project management team.

They are looking for a Clinical Project Manager with ophthalmology experience to own studies from start-up through close-out. This is a genuine ownership role in a collaborative organization, where you will have direct visibility with senior leadership and the chance to shape how studies are delivered.

About The Job:

• Act as the main sponsor contact, advising on study strategy and keeping delivery on track.
• Take ownership of delivery from start-up to close-out, covering timelines, budgets, scope changes and team resourcing.
• Manage vendors and keep day-to-day execution on plan.
• Anticipate risks and enrollment challenges, and put mitigation in place before they affect timelines.
• Keep the TMF inspection-ready.
• Keep sponsors and senior leadership informed through regular reporting and forecasts.
• Work alongside a dedicated Study Manager, mentor junior colleagues and contribute to proposals.

Requirements:

• 5+ years of relevant clinical research experience
• Strong knowledge of GCP, ISO standards and FDA regulations
• Ophthalmology study experience; drug or device
• Excellent communication and presentation skills, with strong organization and attention to detail
• Must be US-based

Why this role:

• A role that is central to client success, not a small piece of a large process
• A supportive, experienced line manager who backs you with difficult sponsors
• Manageable workloads, typically one to two projects at a time
• Deliberate growth due to consistent new business wins
• Competitive salary & benefits
• Fully remote working