Senior Clinical Project Manager

Ora is the world’s leading full-service ophthalmic drug and device development firm, guiding clients across all phases of clinical research. The Senior Clinical Project Manager will drive clinical ophthalmic projects, ensuring budgets, timelines, and trial requirements are met, while managing cross-functional teams and providing support to junior members.

Responsibilities:

• May manage department Clinical Project Managers, Assistant Project Managers, Clinical Trial Associates and other supporting staff
• Manages cross functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s) in compliance with all regulations and SOPs
• Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects. The CPM acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, manufacturing, regulatory, vendors), coordinating these different groups in a matrix environment to drive and complete clinical programs
• Reviews protocol, source documents and CRFs and tracks them to completion
• Responsible for creating and maintaining project timelines for each project and uses these timelines to track and manage a project’s progress
• Responsible for creating Project Plans (Roles and Responsibility Tables and Communication Plans) and weekly project budget and progress reviews for each study
• Reviews study metrics for performance and quality with the team and management
• Prepares high-quality reports (financial, project, etc.) for management on program status and issues
• Ensures review of clinical electronic Trial Master File (eTMF) for completeness
• Manages and coordinates all vendors involved in the clinical trials (e.g. central labs, IVRS, reading centers)
• May represent Ora at professional meetings or seminars
• Participates in preparing new study budgets, proposal documents and participating in bid defenses
• Active role in department and company-wide process improvement initiatives
• Travel of up to 15% is required (mainly domestic, overnight)
• Adhere to all aspects of Ora’s quality system
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements
• Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors

Requirements:

• Bachelors' degree in Life Science with at least 7 years of clinical trial experience. Years of experience may be considered in lieu of education
• Minimum of 3 years of clinical project management experience
• Ability to establish and maintain effective professional relationships with co-workers, managers and clients
• Highly effective organizational and communication skills
• Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term company objectives
• Demonstrated expertise of applicable regulatory requirements and GCP
• Demonstrated leadership skills and the ability to multitask and to solve problems proactively
• Proficiency with Excel, PowerPoint and vendor management
• Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors
• Ophthalmology experience preferred
• Understanding of multi-center drug and/or device trials
• Experience with Veeva TMF and CTMS systems
• Multi-lingual communication is a plus