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:
Works as part of a project team to design and implement clinical database applications in support of clinical research and biostatistics analysis. Works with clinical data managers and biostatisticians to develop database build specifications and gain acceptance through user testing. Develops data entry screens and programs, and data quality edit checks to comply with related specifications. Accomplishes database structure testing. Processes database programming change requests. Documents all work fully according to FDA regulations and guidance and company SOPs. Communicates database build, edit check programming and related document review statuses to management and the project teams.
What You’ll Do:
Assist in developing, validating, and maintaining clinical databases for clinical trials, using various validated software applications.
Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management plans.
Build and validate data entry screens (paper and/or electronic data capture EDC).
Implement and test data quality checks in accordance with the study data validation manual.
Utilize copies of like database elements from library structures or other similar studies during builds.
Assist in batch loading external data from vendors (e.g., central lab data).
Assist in management of user access to clinical databases.
Participate in writing departmental documentation (e.g., training documents, process guidance’s).
Participate in other clinical programming and data management activities, as required.
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 computer science or other quantitative or related, scientific field.
Commensurate experience with clinical database programming and database administration will be considered as an alternative to a degree.
o C++, .NET, Visual Basic or other object-oriented language, and/or SAS programming knowledge/ experience not required, but desirable.
Additional Skills and Attributes:
Excellent understanding of relational database structures.
Fast, accurate programming skills using assorted application software.
PL/SQL, SQL, and XML programming skills.
Strong job administration skills in a team-based and time-pressured environment: organization, attention to detail, prioritization, multi-tasking, communication (written and verbal), problem-solving and collaboration.
Demonstrated ability to provide “user friendly” and technically accurate documentation.
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.
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.
Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Pharmaceutical Manufacturing
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