Director of Clinical Operations

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: Director, Clinical Operations

DEPARTMENT: Clinical Site

LOCATION: In-Person, Andover, MA

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:

The Director, Clinical Operations is responsible for overseeing all clinical operations and assigned clinical trials as well as providing leadership in the implementation of new process improvements across future and ongoing programs. The role requires active involvement to meet schedules or resolve problems or conflicts, and entails frequent interaction with clients, functional peer groups at various management levels and senior management. This position provides departmental leadership on staffing, budgeting, and operational topics.

What You'll Do:

• Global oversight to Manager of Operations, Study Coordinator, CRCs activities and deliverables and associated staff.
• Oversees ongoing process improvement in clinical study execution- Leads pre study visit walk through with props training session; captures and disseminates, lessons learned following each visit/study.
• Schedule and review project tasks, providing leadership in the delivery of services to clients across multiple clinical programs and ensuring staff fulfills their responsibilities in accordance with client's policies, procedures, SOPs, ICH-GCPs.
• Responsible for creating and maintaining timelines for each project, and use these timelines to track and manage a project's progress to timely completion in compliance with all regulations and SOPs.
• Writing study plans, including Study Management Plans, Recruitment Plans, Communication Plans.
• Primary point of contact between Sponsor and site. Develop the frequency, attendee list, and agenda of Sponsor/Site calls. Capture minutes and action items.
• Prepare project status reports, both internally for Andover Eye Institute and for the Sponsor.
• Provide estimates for resources, hours and non-labor costs to be used in project budgeting and oversee development of site contracts. Overall responsibility to deliver the projects on time and on budget. Responsible for providing reporting weekly project status update on project costs across all department clinical programs.
• Provide inputs to accounting for invoicing of studies.
• Writing of study documents, including protocol, ICF, source documents and study logs and or QC of documents.
• Interface with data management and statistics group and coordinate these activities in concert with them as well as other vendors required in the department activities.
• Oversight of clinical studies, including site start-up (e.g. completion of regulatory documents and IRB approvals), subject recruitment, data entry/transcription, timely completion of logs (e.g. Screening/Enrollment and AE logs, EDC tracking). Provide oversight at clinical study visits as needed.
• Interface with monitoring department and CRAs to coordinate monitoring activities in concert with them, as agreed upon in the study monitoring plan. Aide in follow-up with the sites to ensure timely completion of action items from monitoring visits.
• Communicate status of study by ensuring study tracking logs are updated on a weekly basis. Participation in weekly update calls with Sponsor and data management/statistics group.
• Oversee and review writing of minutes, including action items, from team and Sponsor conference calls.
• Comply with regulatory, GCP, ICH, and SOP guidelines.
• Participate in client presentations
• Responsibilities may differ slightly from the above based on specific needs of the business.

What We Look For:

• Experience Needed for the Role:
  • Bachelor's degree in applied or life science, a minimum of 8 years' experience in clinical trials, Ophthalmic or equivalent training and work experience.
  • Knowledge and experience with Ophthalmology clinical trials is required.
• Additional Skills & Attributes:
  • Ability to lead and manage complex development programs/teams and to deliver high quality programs within budget and timelines.
  • Manage cross functional teams and demonstrate leadership and oversight of department activities.
  • Understand, follow, and properly execute the roles and responsibilities as defined in the agreement with the Sponsor.
  • Ability to prepare and or QC a clinical trial outline, protocol, informed consent form, source document, and an investigator study summary.
  • Aptitude to coordinate clinical trial timelines and resources.
  • Ability to track and report clinical trial timelines and resources.
  • Strong interpersonal skills.
  • Proficient in the Microsoft Office Suite.
  • Proficient in Excel.
  • Experience with eSource a plus.
  • Excellent written and verbal communication skills.
  • Excellent organization and time management skills.
• 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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