POSITION TITLE: Senior Director Monitoring
DEPARTMENT: Monitoring
Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
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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 methodologies, 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:
The Senior Director Monitoring Services is responsible for assisting with the planning, resourcing, and the execution of Ora’s monitoring activities. This individual provides strategic oversight and operational leadership with a focus on the development and maintenance of accurate operational plans including department and project timelines as well as budgets.
In collaboration across the organization, this individual will be responsible for planning, launching and strategies for growth, and new approaches to monitoring clinical trials such as Risk Based Monitoring. The Senior Director will develop and revise robust training, onboarding and site management programs. This individual must have the ability to balance multiple variables associated with this highly collaborative, matrixed role.
This individual will supervise and mentor a team of monitoring managers across the United States and support harmonization of global processes.
What You’ll Do:
- Supervise and coordinate Clinical Management functions, including mentoring managers in day-to-day activities and responsibilities related to the clinical deliverables.
- Play a key role in defining Risk Based Monitoring activities which will be the basis of clinical monitoring trial delivery. This includes in-depth knowledge around Risk and Mitigation planning.
- Ensure the timely execution of clinical deliverables with a focus on quality. Facilitate meetings to identify potential risks and work with the clinical team to develop and communicate contingency or mitigation plans.
- Ensure risks to clinical deliverables and potential solutions are communicated through appropriate escalation pathways.
- Participate in review of clinical project or program finances and ensures risks are escalated appropriately with any information necessary for a contract modification.
- Support the management of clinical management resource levels including allocation to projects, hiring and promoting, as appropriate.
- Develop a plan to induct new team members to Ora where appropriate.
- Experience with systems development and deployment a plus.
- Provide performance appraisals, evaluate and allocate bonuses and merit increases, as appropriate.
- Ensures staff is trained and mentored according to company policies and procedures. Assists in the development and implements and reviews key performance metrics.
- Contribute to development of a human capital plan to drive a profitable P&L of the department as well as ensure the employees are engaged as Ora’s most important asset. This includes creative strategies for onboarding, retention of staff, and career progression.
- Contribute to project specific proposals and budgets, with key focus on Risk Based Modeling for clinical monitoring.
- Participate in global and/or cross-functional initiatives and process improvement projects.
- Manage partnerships with third party vendors, customers, and key research sites as requested or required.
- Participate with business development in the generation and support of new business to Ora (e.g. proposals, bid meetings, budget development).
- 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 in a life science related field or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
- Thorough knowledge of and experience in risk-based monitoring principles including adherence to ICHE6R2 requirements in monitoring plan development and deployment.
- Experience managing globally for trial and project delivery.
- Significant clinical research experience (comparable to 12+ years) including at least 5 years’ experience in risk-based models including remote and clinical monitoring.
- Line management experience appropriate to the size and complexity of the clinical management group globally.
- Valid Driver's License and Passport.
- Travel is estimated at 25%
- Additional Skills and Attributes:
- Demonstrated experience in system development with understanding of technical requirements for deployment of software.
- Strong financial acumen with experience meeting (exceeding) revenue and margin targets.
- Demonstrated ability to lead and manage a matrixed team including Managers, Lead CRAs, CRAs and/or other monitoring staff.
- Ability to assess monitor qualifications and facilitate the deployment of a team of highly skilled and properly educated monitors.
- Understanding of monitoring principles, ICH guidelines, Code of Federal Regulations governing research, and the standards defining GCP.
- 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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