Demo

Monitoring Manager

Ora
Andover, MA Temporary
POSTED ON 1/14/2025
AVAILABLE BEFORE 4/10/2025

Job Description

Job Description

POSITION TITLE : Monitoring Manager

DEPARTMENT : Monitoring

Ora Values the Daily Practice of …

Prioritizing Kindness

  • Operational Excellence
  • Cultivating Joy
  • Scientific Rigor

At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodlogies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

The Role :

This position provides direct oversight to members of the monitoring team including CRAs and / or Lead CRAs and may be called upon to interact independently with clients and to assist in wider company tasks. The Clinical Monitoring Manager is responsible for ongoing evaluation of current and upcoming work to evaluate the resource needs of the department to ensure the monitoring team is achieving utilization targets. In addition, the individual serving in this role understands how to assess the qualifications of monitors in order to be able to deploy a highly skilled and properly educated team. This position works collaboratively with cross-functional teams and independently to support the clinical trial activities.

What You'll Do :

  • Create, update, implement and conduct onboarding training to ensure direct reports are qualified to conduct duties in an efficient and timely manner
  • Track ongoing training compliance to confirm direct reports are appropriately trained within expected timeline(s)
  • Suggest additional strategies to ensure direct reports are knowledgeable on current industry trends and information
  • Actively participate in the processes to recruit, interview and select CRA and Lead CRA candidates
  • Utilize technology and database information to project resourcing needs. Regularly maintain the resourcing database for direct reports and provide hiring decisions to senior management
  • Utilize metrics and key performance indicators to manage individual and team performance. Implement action plans to address potential barriers to achieving expected performance
  • Attend on-site visits to ensure CRA compliance with study-related and company processes. Implement action plans for any required improvements
  • Oversee compliance for data entry into CTMS and regulatory document submission into the trial master file
  • Approve time reporting and expenses for direct reports
  • Participate in study budget review meetings and complete monitoring budget assessments
  • Ensure career development goals of each direct report are met through regular meetings, performance reviews / appraisals and assisting staff in accessing career development opportunities
  • Provide mentorship, coaching and work direction to direct reports
  • Document and follow, to resolution, any actionable issues requiring a correction action plan
  • Lead and / or contribute to monitoring department and cross-functional company initiatives
  • Travel Requirements up to 25%.
  • Adhere to all aspects of Ora's quality system.
  • Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
  • Clear and sustained demonstration of Ora's 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 with 6 years' experience as a Clinical Research Associate or equivalent combination of education, training and experience. Years of experience may be considered in lieu of education

  • Minimum of 1 year of management or leadership experience, preferably in a CRO setting
  • Additional Skills & Attributes :
  • Ophthalmic experience strongly preferred

  • Understand how to properly assess monitoring capabilities for conducting clinical research.
  • Strong attention to detail in order to review CRA visit reports and assess eTMF
  • Excellent written and verbal communication skills
  • Extensive experience in the conduct of site evaluation, initiation, interim, and close-out visits.
  • Advanced Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
  • 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. At Ora, we are creating vision beyond what we see.

    What We Offer :

  • Well Being : Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
  • Flexible PTO & Unlimited Sick Time : Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
  • Financial : Competitive salaries along with a 401K plan through Fidelity with company match.
  • Family Support Care : Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
  • Company Paid Life & Disability Insurance : Offering peace of mind to help you and your family feel secure.
  • Remote & Wellness Reimbursement : We'll reimburse you to support your remote workspace and wellness purchases.
  • 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.
  • Global Team : Opportunities to work with colleagues across the globe.
  • Impact : A chance to research new ophthalmic therapies that will impact patients across the globe.
  • Benefit Eligibility : Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.

    Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values : Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

    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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