Manager/Senior Manager, Clinical Documentation Management

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🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

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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

• Manage and develop a portion of the Clinical Documentation (eTMF) team, supporting performance, workload prioritization, and professional growth • Reinforce operational excellence and consistency in eTMF execution across assigned studies • Provide day-to-day guidance and mentorship on documentation processes and quality expectations • Ensure eTMF activities align with ICH-GCP, GxP, and applicable local regulatory requirements • Partner with Quality Assurance and study teams to maintain compliance across assigned projects • Support internal and external audits, including documentation preparation and responses to findings • Refine and implement eTMF processes, SOPs, work practices, and templates • Identify process gaps, propose enhancements, and support continuous improvement initiatives • Review eTMF quality metrics, identify trends, and support corrective actions • Deliver eTMF training and communicate procedural updates and best practices • Serve as a resource for Good Documentation Practices, TMF Reference Model alignment, and eTMF guidance • Monitor eTMF completeness, accuracy, and risk indicators; escalate issues to the Senior Director as needed • Conduct periodic eTMF quality checks and support reconciliation and close-out activities • Support implementation, maintenance, and user adoption of document management systems such as Veeva Vault and SharePoint • Act as an eTMF system super-user, providing guidance and troubleshooting support • Ensure compliant document archiving according to SOPs and study scope • Assist with client qualification or project-specific audits and follow-up actions • Ensure adherence to client SOPs and regulatory requirements • Travel up to 10% • Adhere to and reinforce Ora’s quality system, data integrity standards, and business ethics

🎯 Requirements

• Bachelor’s degree in Life Sciences or related field, or equivalent work experience • 5+ years of experience in clinical operations, clinical documentation, quality, or a related function within pharmaceutical or CRO environments • Minimum 2 years of experience with eTMF or record management systems • Senior Manager level: 3+ years of people management experience • Manager level: minimum 1 year of people management, team lead, or supervisory experience • Experience with Veeva Vault eTMF or other document management systems (Veeva Vault preferred) • Strong understanding of ICH-GCP, TMF Reference Model, and documentation best practices • Ability to manage workloads, meet timelines, and operate under time constraints • Strong analytical and problem-solving skills, including interpreting quality trends • Clear and consistent writing skills; experience contributing to SOPs or process documents • Ability to support organizational change and work effectively in a matrix environment • Excellent verbal and written communication skills, including presenting to cross-functional teams • Up to 10% travel • Full-time employees must work a minimum of 30 hours per week for benefit eligibility

🏖️ Benefits

• Comprehensive Medical, Dental and Vision healthcare options beginning day 1 • Flexible PTO • Unlimited sick time • 14 company-paid holidays • 401K 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 with global patient impact