POSITION TITLE: Associate Clinical Project Manager

DEPARTMENT: Anterior Segment

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

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The Role:

Ora's Associate Clinical Project Managers (ACPM) are critical in driving clinical ophthalmic projects forward utilizing best practices in order to ensure budgets, timelines, and clinical trial requirements are being met on behalf of the sponsor. This role will work independently and with oversight as needed to manage cross functional project teams. Assistant CPM's have active involvement in each assigned project in order to meet milestones, resolve issues and/ or conflicts in addition to frequent interactions with the study team including but not limited to clinical trial associates, monitoring, clinical research coordinators, investigators and senior management. They are responsible for creating project plans, with direction, and provide weekly budget and progress reviews for each study in addition to preparing high-quality reports.

What You'll Do:

• Independently and with oversight as needed 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 Assistant 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.
• Independently and with oversight as needed, reviews protocol, source documents and CRFs and tracks them to completion.
• With oversight, 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, with direction from senior leadership 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, IWRS, reading centers).
• May represent Ora at professional meetings or seminars.
• Responsibilities may differ slightly from the above based on specific needs of the business.
• Clear and sustained demonstration of the Ora Clinical's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
• Travel of up to 15% is required (mainly domestic, overnight).

What We Look For:

• Experience Needed for the Role:
  • Bachelor's degree in Life Science with at least 3 years of clinical trial experience. Years of experience may be considered in lieu or education.
  • Minimum of 1 year of Sr. Clinical Trial Associate or similar role in clinical research industry
• Preferred Qualifications:
  • Ophthalmology experience preferred.
  • Understanding of multi-center drug and/or device trials.
  • Experience with Veeva TMF and CTMS systems.
  • Demonstrated expertise of applicable regulatory requirements and GCP.
  • Proficiency with Excel, PowerPoint and vendor management.
  • Multi-lingual communication is a plus
• Competencies and Personal Traits:
  • Attention to Detail: Ability to analyze available data and take the time to understand as full a picture as possible to drive successful solutions to complex problems.
  • Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy. Possess the capacity to understand others and to be aware of and sensitive to the feelings, thoughts, and experience of your colleagues and customers.
  • Intellectual Curiosity: A person's willingness and desire to learn new things and dig deeper than the surface. Intellectual curiosity makes learning a much more natural process, instead of just a duty or a chore. When you're intellectually curious, you're more willing and interested to acquire knowledge. You naturally ask more questions and seek to understand why things are the way they are.
  • Innovative Mindset: Forward thinking, creative and open to testing, making mistakes and trying again; collaborative and progress-loving, you honor the past but embrace change because the new is always coming!
  • Organization and Goal Setting: Ability to set goals, delegate appropriate tasks, maintain a focused approach to critical path work and develop structure for yourself and your team to allow for productive, high-quality workflows and decision making.
  • Resolve Conflicts: Practice radical candor in your communication with your team and colleagues as well as participating in active listening to help the other person feel heard and understood.
  • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team with diverse and complimentary skill sets that works together under shared values to achieve significant positive impact in the wider world. Live a clear and sustained demonstration of the daily practice of Ora's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor and the linked behavioral expectations.