Senior Clinical Project Manager

What You’ll Do

• 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).

What We Look For

Experience needed for the Role: 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.

Additional Skills & Attributes

• Ophthalmology experience preferred.
• 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.
• Multi-lingual communication is a plus.