Clinical Operations Project Manager

2 weeks ago

Andover, Massachusetts, United States Ora Full time
Job Overview

POSITION TITLE: Clinical Project Manager

DEPARTMENT: Posterior Segment

About Us: At Ora, we are at the forefront of ophthalmic clinical research, recognized as the premier full-service firm in drug and device development. Our mission is to assist clients throughout all stages of clinical research, ensuring the efficient introduction of innovative products and therapies to the market. With over 45 years of experience, our expert teams have successfully facilitated more than 85 product approvals. Our refined methodologies, integrated data solutions, and global regulatory strategies have been tested across numerous international projects. Today, we continue to grow, employing over 600 professionals across North America, Europe, Asia, and Latin America.

Role Summary: The Clinical Project Manager (CPM) plays a pivotal role in advancing clinical ophthalmic projects by implementing best practices to meet budgets, timelines, and trial requirements for our sponsors. This position requires independent management of cross-functional project teams, with active engagement in each project to achieve milestones, address challenges, and maintain regular communication with the study team, including clinical trial associates, monitors, coordinators, investigators, and senior management. The CPM is responsible for developing project plans and conducting weekly budget and progress assessments for each study, in addition to producing high-quality reports.

Key Responsibilities:

  • Lead cross-functional project teams from various clinical development sectors to ensure the delivery of high-quality clinical trials in accordance with all regulations and standard operating procedures (SOPs).
  • Collaborate with functional areas to initiate, plan, execute, control, close, and allocate resources for clinical trial projects, acting as a central point of coordination among diverse groups.
  • Review protocols, source documents, and case report forms (CRFs), ensuring their completion.
  • Establish and maintain project timelines, utilizing them to monitor and manage project progress.
  • Create and uphold Project Plans, including Roles and Responsibility Tables and Communication Plans, alongside weekly budget and progress reviews.
  • Analyze study metrics for performance and quality in collaboration with the team and management.
  • Prepare comprehensive reports (financial, project status, etc.) for management regarding program developments and challenges.
  • Ensure the thorough review of the clinical electronic Trial Master File (eTMF) for completeness.
  • Oversee and coordinate all vendors involved in clinical trials.
  • Represent the company at professional meetings or seminars as needed.
  • Contribute to the preparation of new study budgets and proposal documents, participating in bid defenses.
  • Engage actively in departmental and company-wide process improvement initiatives.
  • Willingness to travel up to 15% (primarily domestic, overnight).
  • Adhere to all components of Ora's quality system and essential processes to maintain compliance with data integrity, business ethics, and regulatory standards.
  • Consistently demonstrate Ora's core values: prioritizing kindness, operational excellence, cultivating joy, and scientific rigor.
  • Responsibilities may vary based on specific business needs.

Qualifications:

  • Experience:
    • Bachelor's degree in Life Science with a minimum of 5 years of clinical trial experience; relevant experience may substitute for education.
    • At least 1 year of clinical project management experience.
  • Preferred Skills:
    • Experience in ophthalmology is advantageous.
    • Familiarity with multi-center drug and/or device trials.
    • Experience with Veeva TMF and CTMS systems.
  • Competencies:
    • Execution Excellence: Ability to set objectives, create structure, and maintain a focused, collaborative approach to delivering timely, high-quality work.
    • Communication and Feedback: Engage in clear and direct communication, practicing radical candor and actively participating in feedback processes to foster a culture of growth.
    • Meaning and Purpose: Desire to contribute to a team that shares values and strives for significant positive impact in the world.

What We Offer:

  • Comprehensive Well-Being: Extensive healthcare options in Medical, Dental, and Vision starting from day one.
  • Flexible Time Off: Enjoy flexible PTO and unlimited sick time, along with 14 paid holidays.
  • Financial Security: Competitive salaries and a 401K plan with company matching.
  • Family Support: Adoption and fertility assistance, plus 16 weeks of paid parental leave.
  • Insurance Coverage: Company-paid life and disability insurance for peace of mind.
  • Remote Work Support: Reimbursement for remote workspace and wellness expenses.
  • Employee Assistance: Access to support services for personal challenges.
  • Career Development: Opportunities for ongoing professional growth and development.
  • Global Collaboration: Work with colleagues from around the world.
  • Impactful Work: Engage in research on new ophthalmic therapies that will benefit patients globally.

Eligibility: Full-time employees working a minimum of 30 hours per week are eligible for benefits. Per diem employees qualify for Medical and Dental coverage after 6 months of service and an average of 30 hours per week.

At Ora, we strive to integrate people, processes, and technology to foster innovation in ophthalmology worldwide. Our commitment to our core values—prioritizing kindness, cultivating joy, operational excellence, and scientific rigor—creates an inclusive and supportive work environment that promotes respect, accountability, and a healthy work-life balance for all team members.

We celebrate diversity and encourage individuals from all backgrounds, including people of color, the LGBTQIA+ community, disabled candidates, and veterans, to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, dedicated to fair employment practices and equitable compensation.

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