Manager Operational Strategy
2 months ago
POSITION TITLE: Manager, Operational Strategy
DEPARTMENT: Anterior Segment
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 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:
Ora's Manager, Operational Strategy, plays a key role in the strategy, planning, and execution of Anterior Segment (AS) studies. This role serves as a team leader for AS studies and is responsible for the creation of project-specific plans and establishing a connection between clinical sites and Ora's clinical research coordinator teams. The Manager, Operational Strategy, serves as a liaison to Project Managers and is a resource for clients on clinical operations expertise.
What You'll Do:
- Function as Operations Manager for 2-6 clinical research studies:
- Responsible for clinical site timing, site volume, and overall enrollment planning and execution for any AS study assigned primarily Ora's model/SMO studies.
- Partners with Patient Recruitment to develop site strategy for each project, balancing the need of the study with overall capacity models.
- Directly communicates and schedules clinical site visits with investigators and sites to meet the timelines and volume needs of each project.
- Works closely with the PM team to ensure clinical start-up activities that impact recruitment and enrollment performance are completed on time (e.g., completion of regulatory documents and IRB approvals).
- Work with the Training Manager to ensure clinical research coordinators can perform all tasks associated with the study protocol.
- Works with a Scheduling Strategist to ensure all clinical visits are staffed properly with the SMO team based on visit specifics (procedures, site, patient volume, etc.)
- Attend high-profile study visits (enrollment and/or primary efficacy visits)
- Attend weekly project calls with the CRO team and sponsors from start-up through enrollment, representing SMO operations, site selection, and enrollment performance.
- Continued communication with Supervisors on-site to resolve any outstanding study-specific issues.
- Primary point of contact for all operations-related queries from the site (study visit timing, mobile CAE scheduling, staffing assignments) and escalation point to project management/senior management.
- Works with CAE team to ensure site scheduling is in line with CAE availability and adjustment of schedules in real-time (if applicable)
- Manages Anterior Segment Overview and ensures data from managed trials is accurate.
- Tracks study screening and enrollment metrics and shares with clients regularly
- Develops contingency strategies if enrollment rates are below expectations.
- Develop strong relationships with new and existing Investigators/Sites
- Represent SMO operations to sponsors and attend client-facing meetings as needed.
- Work with the entire Operational Strategy arm of the business, in addition to Patient Recruitment, Project Management, and senior management to schedule clinical site block visits within timelines, budgets, and scope.
- May serve as budget development lead for SMO for applicable RFPs with Business Development Operations and Senior Management
- Support the CRO team in site budget discussions and CTA execution
- Develop clinical study flow to ensure proper trial budgeting and efficient CRC staffing and execution
- Review drafts of study documents, including ICF, source documents, procedure manual, and study
- Assist management in the preparation of project status reports, both internally and externally.
- Responsible for post-study analysis including, screening and enrollment metrics, study wide and site-specific screen fail rates, and reasons for screen fail
- Continue to develop clinical study management skills through clinical trial visits when needed.
- Comply with regulatory, GCP, ICH, and SOP guidelines.
- Responsibilities may differ slightly from the above based on the specific needs of the business.
- Clear and sustained demonstration of the Ora Clinical's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
What We Look For:
- Experience needed for the Role:
- Bachelor's degree in applied, life science or other related, scientific field
- 5+ years of experience in clinical trials, or equivalent training and work experience.
- Additional Skills and Attributes:
- Knowledge of the process and documentation required to train and supervise another employee and/or contract
- Understand, follow, and properly execute the roles and responsibilities as defined in the agreement with the
- Ability to prepare an informed consent form, source document, and an investigator study
- Aptitude to coordinate clinical trial timelines and
- Ability to track and report clinical trial timelines and
- Strong interpersonal
- Excellent written and verbal communication
- Excellent organization and time management
- Strong written and verbal communication skills.
- Good knowledge of computer operations and demonstrated computer skills.
- Up to 10% site locations may be required.
- 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 Do:
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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