Senior Clinical Project Manager/ Clinical Project Manager

Ora is a global ophthalmic drug and device development firm that supports clinical research and brings new products and therapies to market. The Senior Clinical Project Manager/Clinical Project Manager manages cross-functional ophthalmic clinical trial projects, overseeing timelines, budgets, quality, vendors, compliance, and project teams.

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
• Responsibilities may differ from the above based on the specific needs of the business

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
• Understanding of multi-center drug and/or device trials
• Experience with Veeva TMF and CTMS systems
• 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
• Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work
• Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again
• Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth
• Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world
• Ophthalmology experience preferred
• Multi-lingual communication is a plus