Clinical Data Manager

POSITION TITLE: Clinical Data Manager

DEPARTMENT: Data Management

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

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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:

Participates in all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout either as a study lead or backup data manager.  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 Analysts.

What You’ll Do:

• Act as Lead Data Manager for one or more projects
• Perform study setup activities including eCRF design, database structure design, document creation and/or approval, eCRF user acceptance testing, validation check user acceptance testing and approval, data transfer agreements, etc. 
• Allocate and prioritize workloads for projects (listing reviews, third party vendor imports, vendor and SAE reconciliations, query management tasks, and data deliverables, etc.)  
• Serve as a primary resource for issues pertaining to data management within assigned projects 
• Serve as an interim resource for issues pertaining to the study in the absence of a Clinical Data Manager  
• Oversee execution of timelines and ensure adherence to budgets as they pertain to data management activities 
• Generate, send and track receipt of Training Forms for new database users, complete User Access Request Forms
• Mentor all levels of Clinical Data Associates in their job responsibilities 
• Maintain quality control of the data, project deliverables and closeouts 
• Perform other duties as assigned
• Support the review of medical coding for validity and completeness 
• Adhere to all aspects of the Ora’s quality management system 
• Comply with Ora’s data integrity & business ethics requirements 
• Perform other related duties incidental to the work described herein 
• 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 three (3) year of experience in clinical data management or  Bachelor’s degree and at least four (4) years of experience in clinical trials, or Current Certified Clinical Data Manager (CCDM) status and at least four (4) years in clinical trials

Additional Skills and Attributes:

• Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process 
• Excellent organizational and project management skills 
• Able to lead teams to complete projects 
• Highly effective communication skills, both written and verbal 
• Technical skills including EDC systems, clinical data management systems, Microsoft Office 
• Additional required skills include the following:  CRF design, MS Project, and analytical capabilities. 
• Familiarity with clinical trial design and basic knowledge 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 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.

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