Manager, Clinical Data Management

🕒 March 10

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 55%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Ora

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏭 Manufacturing

💼 Consulting

📦 Logistics

Manufacturing • Consulting • Logistics

Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 45 years, Ora has helped clients earn more than 85 product approvals, supporting a wide array of organizations from start-ups to global pharmaceutical and device companies. Their offerings include pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies, all refined through thousands of global projects. Ora boasts an extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.

📋 Description

• Oversee and manage clinical data management operations, including staffing, resourcing, project management, budgeting, operations management, and client management • Apply technical expertise to lead data management activities • Serve as study manager on assigned clinical studies, ensuring quality, timeliness, and budget compliance • Manage allocated personnel • Serve as subject matter expert in client and vendor meetings • Support business development capabilities presentations • Provide input for department and clinical study budgets • Liaise with internal and external cross-functional teams, sponsors, and vendors • Mentor data management staff and ensure project planning, resource allocation, and execution • Provide direction when staff cannot resolve issues independently • Ensure staff training and development, including creating or updating SOPs, work instructions, forms, and templates • Conduct regular meetings and complete year-end performance reviews with direct reports • Monitor team performance and initiate process and resource improvements with Data Management leadership • Participate in departmental initiatives • Adhere to Ora’s quality, data integrity, business ethics, and regulatory requirements • Demonstrate Ora’s values and perform other related duties as needed

🎯 Requirements

• Master’s degree, preferably in Engineering, Applied or Life Science, and at least five (5) years of experience in Clinical Data Management including leading several clinical studies, or a Bachelor’s degree, preferably in Engineering, Applied or Life Science, or equivalent education and work experience with a minimum of six (6) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status and six (6) years of experience in clinical trial • Two (2) years of experience direct management of personnel is required • Extensive experience in Clinical research • Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations • Strong project management abilities, including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills • Effective leadership, budget forecast and implementation skills • Articulate and professional • Clinical research in a CRO setting and CDISC SDTM training preferred • EDC experience in multiple EDC systems including Medidata Rave preferred • May require travel up to 10% • Ability to adhere to Ora’s quality system, data integrity, business ethics, regulatory requirements, and essential systems and processes

🏖️ Benefits

• Comprehensive medical, dental, and vision healthcare options beginning day 1 • Flexible PTO • Unlimited sick time • 14 company-paid holidays • 401(k) plan through Fidelity with company match • Adoption and fertility assistance • 16 weeks paid parental leave • Company-paid life and disability insurance • Remote workspace and wellness reimbursement • Employee Assistance Program • Career development opportunities • Opportunities to work with colleagues across the globe • Opportunity to research new ophthalmic therapies impacting patients globally