POSITION TITLE: Sr Clinical Data Associate 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 forty years, our expert teams have helped earn more than fifty new product approvals. Today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia. The Role: Coordinates data management activities in support of clinical and/or non-clinical research studies including document management, query management, database setup and testing, and quality control of the data and project deliverables. What You’ll Do: Track and maintain audit-ready clinical study documentation within the electronic and/or hard copy Trial Master Files for multiple projects Perform query management including data listing review, query creation and resolution, ensuring data is complete, consistent and accurate Perform advanced aspects of data cleaning process, including reconciliation of Serious Adverse Events and third-party vendor data, or other cleaning tasks as necessary Assist Clinical Data Manager(s) in prioritizing project workloads, as needed May participate in database setup including data entry screen and validation check user acceptance testing, updates to eCRF Completion Guidelines or other CDM study documentation, with oversight from Clinical Data Manager Serve as an interim resource for study issues pertaining to data management in the absence of the Clinical Data Manager Mentor and train Clinical Data Associates in query management and other data cleaning activities Maintain quality control of the data, project deliverables and closeouts Track and maintain audit-ready clinical study documentation within the electronic Trial Master Files for multiple projects, with Clinical Data Manager oversight Participate in internal and external team meetings, as necessary 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, preferably in applied or life science, with 1-3 years of experience in data management of clinical trials or equivalent education and work experience. Additional Skills and Attributes: Working knowledge of clinical trials and data management’s role in the clinical trials process Proficiency with Microsoft Word and Excel software and other MS office products (MS PowerPoint, MS Project, etc.) Ability to work well in a team environment Excellent organizational skills and attention to detail Ability to successfully work on multiple projects and prioritize daily tasks and responsibilities Effective communications skills both written and verbal Possess strong problem-solving skills, be solution-oriented Familiarity of regulatory guidelines (FDA/CFR, ICH/GCP) Competencies and Personal Traits: Attention to Detail : Ability to analyze data to drive successful solutions to complex problems. Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy. Intellectual Curiosity : Willingness and desire to learn new things and dig deeper than the surface. Innovative Mindset: Forward thinking, creative and open to testing, making mistakes and trying again. Organization and Goal Setting: Ability to set goals, develop structure and maintain a focused approach to critical path work. Resolve Conflicts: Practice radical candor in your communication and participate in active listening to help the other person feel heard and understood. 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. 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. Our Privacy Policy | Ora (oraclinical.com)
