Remote Senior Clinical Project Manager - Ophthalmic Trials

Ora; United States; Teletrabalho; USD 120 000 - 170 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Healthcare benefits

Flexible PTO

401K with match

Parental leave

Life & disability insurance

Remote stipend

Career development

Resumo da oferta

Ora is seeking a Senior Clinical Project Manager/Clinical Project Manager to lead ophthalmic clinical programs from initiation to close-out. This remote US-based role requires directing cross-functional teams, developing study plans, monitoring budgets, timelines and trial deliverables, and ensuring regulatory and quality standards are met.

You will collaborate with study teams, vendors, and sponsors while driving process improvements and maintaining Ora's standards of scientific rigor and

Qualificações

• Bachelor's degree in Life Science with at least 7 years of clinical trial experience.
• Minimum of 3 years of clinical project management experience.
• Ophthalmology experience preferred.
• Experience with Veeva TMF and CTMS systems.
• Ability to establish and maintain effective professional relationships with colleagues and clients.
• Strong organizational and communication skills.
• Ability to plan, identify risks, anticipate issues and respond strategically.
• Regulatory knowledge and GCP experience.
• Demonstrated leadership and multi-tasking abilities.
• Proficiency with Excel and PowerPoint; vendor management experience.

Responsabilidades

• May manage department Clinical Project Managers, Assistant Project Managers, Clinical Trial Associates and other staff.
• Manages cross functional project teams to deliver high quality trials in compliance with regulations.
• Coordinates interdepartmental groups in a matrix environment to drive programs.
• Reviews protocol, source documents and CRFs; tracks progress to completion.
• Creates and maintains project timelines and conducts weekly budget reviews.
• Prepares reports on program status and issues for management.
• Ensures eTMF completeness.
• Manages vendors involved in trials (labs, IVRS, reading centers).
• Represents Ora at meetings or seminars when needed.
• Contributes to budget proposals and bid defenses; participates in process improvements.

Conhecimentos

Ophthalmology experience

Project leadership

Stakeholder management

Regulatory knowledge

Clinical project management

Formação académica

Bachelor's degree in Life Science

Ferramentas

Veeva TMF

CTMS

Descrição da oferta de emprego

Ora is seeking a Senior Clinical Project Manager/Clinical Project Manager to lead ophthalmic clinical programs from initiation to close-out. This remote US-based role requires directing cross-functional teams, developing study plans, monitoring budgets, timelines and trial deliverables, and ensuring regulatory and quality standards are met.

You will collaborate with study teams, vendors, and sponsors while driving process improvements and maintaining Ora's standards of scientific rigor and