POSITION TITLE: Senior Clinical Data Manager 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: Oversees and coordinates all data management activities in support of clinical and/or non-clinical research studies for study initiation, set up, maintenance, and close out. Manages the day-to-day data management project activities including, but not limited to timelines, budgets, staff, project scope, reports and communication for the lifecycle of the project(s). Mentors/trains Clinical Data Managers and Clinical Data Analysts. What You’ll Do: Act as Lead Data Manager for one or more high complexity projects or programs, demonstrating independence and initiative to ensure project success Perform and oversee study setup including eCRF design, database structure development, document creation and/or approval, data entry screen and edit check testing and approval, data transfer agreements, etc. Proactively plan, allocate and prioritize workloads for multiple projects (to include listings review, third party vendor imports, vendor and SAE reconciliation, query management tasks, and data deliverables, etc.) Work independently to oversee day to day data management project activities Establish, monitor and maintain timeline for data management responsibilities Generate, send and track receipt of Training Forms for new database users; complete User Access Request Forms Mentor clinical data managers and clinical data associates Manage tasks and timelines as they pertain to data management activities on projects Communicate with cross functional groups throughout the project lifecycle Plan and conduct internal and external team meetings Participate in presentations to clients, sites, and cross functional groups Monitor project budget and project scope, as they relate to data management activities, and communicate project status regularly to senior management Provide project team with regular updates on project progress pertaining to data management activities Assume full project management responsibility for all data management activities Train site coordinators, Clinical Research Associates, and investigators on clinical data entry, discrepancy management, CRF page verification, and CRF page approval processes Develop, maintain, and analyze assigned project metrics such as completed pages, discrepancy aging, etc. Establish causes and implement corrective actions for adverse trends that are identified. Participate in and/or contribute to Sponsor and Regulatory audits/inspections, as necessary Maintain quality control of the clinical data, project deliverables and closeouts Oversee the review of medical coding for validity and completeness Adhere to all aspects of Ora’s quality system Comply with Ora’s data integrity and business ethics requirements Perform other duties as assigned Adherence to all essential systems and processes that are required at Ora to maintain compliance to business and regulatory requirements. What We Look For: Master’s degree (preferably in engineering, applied or life science) and at least four (4) years of experience in clinical data management including leading several clinical studies, or Bachelor’s degree (preferably in engineering, applied or life science) or equivalent education and work experience with a minimum of five (5) years of experience in clinical trials, or Current Certified Clinical Data Manager (CCDM) status and five (5) years of experience in clinical trials. Additional Skills and Attributes: Exceptional working knowledge of clinical trials and the data management role in the clinical trials process Excellent organizational and project management skills Good knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations A minimum of 3 years staff mentoring and leadership experience Outstanding leadership capabilities Strong delegation abilities Highly effective written and verbal communication skills in English Technical skills with EDC systems, CDMS and other relational databases, and Microsoft Office products Desirable skills include: CRF design, MS Project, involvement with a federal submission (either NDA or PMA), programming skills (SAS, PL/SQL), analytical capabilities, medical coding (adverse events and medical therapies) Experience in therapeutic areas (TAs) of ophthalmology in clinical trials is preferred 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 tolearn 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. 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. Our Privacy Policy | Ora (oraclinical.com)