POSITION TITLE: Sr. Director, Clinical Data Management
DEPARTMENT: Data Management
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:
Oversees and manages some aspects of data management operations related to the assigned team structure including staffing and staff development, oversight of management team members, project resource planning/loading, project management, leading/supporting implementation of strategies to improve efficiencies, sponsor support, and assuring quality work execution and output. Actively participates in business development and strategic planning. Applies a high level of technical expertise and professional experience to effectively lead data management and clinical programming staff and to develop solution alternatives to problems. Keeps Executive Management apprised of data management project status. Maintains performance metrics that are adequately analyzed for trends, root cause(s) and corrective action(s).
What You'll Do:
- Oversee day-to-day data management operation
- Ensure operational excellence (employee development, on-time and quality-based deliverables) and client service excellence
- Able to promote, demonstrate and mentor team in regard to vision, mission, core values and Quality First
- Serve as subject matter expert during client and vendor meetings
- Actively support business development in capabilities presentations to prospective and current clients
- Effectively manage clinical study budgets and change management processes
- Works with leadership team for department level strategic planning
- Facilitate the collaboration with internal and external cross-functional teams, sponsors, vendors, etc.
- Participate and provide feedback in proposal, contract writing, budget templates/algorithms creation and negotiation
- Reviews/writes/updates standard operating procedures (SOP’s) and work instructions
- Actively works to continuously improve data management operations to reduce cost and timelines and to improve quality
- Develop, maintain, analyze and report on department performance metrics
- Ensure corporate and quality compliance of study teams
- Provide input to department budget
- Develop and conduct in-house training
- Perform other duties as assigned
- Adherence to all essential systems and processes that are required at Ora to maintain compliance to business and regulatory requirement
- 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 applied or life science and minimum of 12 years of experience in clinical trials (with at least 8 years leading a large team in data management) or equivalent education and work experience. Direct leadership of a large team is required.
- Additional Skills and Attributes:
- Extensive experience in clinical data management preferably within a CRO environment
- Successful record of accomplishment in establishing, directing, and overseeing data management operations division/department
- Demonstrated ability to successfully manage compressed study timelines and staff/team members and in accordance with applicable regulations
- Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11
- Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills
- Effective leadership, budget forecast and implementation skills
- Skills including programming and medical coding (adverse events, medical history, and medical therapies) are a plus
- CDISC, CDASH/SDTM training and experience
- EDC experience (Medidata Rave and iMedNet are a plus)
- Experience in multiple therapeutic areas (TAs) in clinical trials including experience in at least two of the following TAs: ophthalmology, oncology, cardiology, central nervous system (CNS), infectious disease, respiratory, endocrinology, gastroenterology
- 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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