Note: The job is a remote job and is open to candidates in USA. Ora is a clinical research company focused on ophthalmic drug and device development. The Director, Clinical Data Management oversees data management operations, including staff and resource planning, project delivery, quality, and efficiency initiatives, while supporting business development and strategic planning.
Responsibilities
- Oversee day-to-day data management operations
- Provide leadership to allocated team guiding overall operations and management of resources to allow for growth of Ora clinical data management and individual team members
- Serve as CDM subject matter expert in cross-functional initiatives and perform expert level customer communication and collaboration activities
- Support business development in capabilities presentations to prospective and current clients
- Manage department and clinical study budgets to achieve or beat targets
- Liaise with internal and external cross-functional teams, sponsors, vendors, etc
- Participate in proposal and contract writing and negotiation
- Review/write/update standard operating procedures, work instructions, forms and templates, ensuring maximum efficiency in CDM processes
- Strive to continuously improve data management operations to reduce cost and timelines, while improving quality
- Manage resourcing and workload of CDM team
- Develop, maintain, analyze and report on departmental performance metrics and KPIs
- Develop and conduct in-house training and development
- Adhere to all aspects of Ora’s quality management 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
Skills
- Bachelor's degree in applied or life science and minimum of twelve (12) years of experience in clinical trials, with at least ten (10) years in data management, or equivalent education and work experience
- Extensive experience in clinical data management preferably within a CRO environment
- Successful leader with a record of accomplishment in establishing, directing and overseeing data management operations division/department in a dynamic environment, including budgeting and forecasting, individual and team leadership, as well as process and project management
- Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11
- CDISC CDASH/SDTM training and experience
- Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work
- 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
- 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
- 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
- Advanced degree and direct supervisory experience
- Experience in ophthalmology
- Skills including programming and medical coding (adverse events, medical history and medical therapies)
- EDC experience (Oracle Clinical Life Sciences Suite and iMedNet)
Benefits
- Remote - US
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