Clinical Project Manager

Please note that this role is not for a position at Ora, Inc. This role is for a position at the company Andover Eye Associates, which is a close working partner of Ora, Inc.

POSITION TITLE: Clinical Project Manager

DEPARTMENT: Clinical Studies

LOCATION: Andover, MA-Onsite

Revolutionizing clinical trials with unparalleled expertise, patient-focused innovation, and a commitment to delivering results that advance medical breakthroughs

At Andover Eye Institute, our mission is to lead the future of eye care through innovative clinical trials and groundbreaking research. We are committed to advancing the understanding and treatment of ophthalmic conditions by exploring new frontiers in medical science. Our team of experienced and compassionate professionals works closely with participants and sponsors, ensuring that each clinical trial is conducted with the utmost care, precision, and attention to detail.

The Role:

Andover Eye Institute Clinical Project Managers (CPM) 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 to manage cross functional project teams. 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 and provide weekly budget and progress reviews for each study in addition to preparing high-quality reports.

What You'll Do:

• 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, finance), coordinating these different groups in a matrix environment to drive and complete clinical programs.
• Reviews protocol, creates source documents, case report forms, other study related documents 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 Trial Master File/study binder for completeness.
• Manages and coordinates all vendors involved in the clinical trials (e.g. central labs, IVRS, reading centers).
• May represent Andover Eye Institute 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.
• Adhere to all aspects of Andover Eye Institute quality system.
• Adhere to all essential systems and processes that are required at Andover Eye Institute to maintain compliance to Andover Eye Institute data integrity & business ethics and regulatory requirements.
Clear and sustained demonstration of Andover Eye Institute 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.

What We Look For:

• Experience Needed for the Role:
  • Bachelor's degree in Life Science with at least 5 years of clinical trial experience. Years of experience may be considered in lieu of education.
  • Minimum of 1 year 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
• Competencies and Personal Traits:
  • What We Do:
    • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
    • IQ, EQ and SQ: 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.
    • Clear and Direct Communication, Feedback and Conflict Resolution: 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.
  • Why We Do It:
    • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.

What We Offer

• Well-Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Time Off: Accrue up to 18 paid days off each year.
• Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.
• Career Development Opportunities: Continued opportunities to grow and develop your career journey.

Benefit Eligibility: Full-time employees of Andover Eye working a minimum of 30 hours per week.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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