Note: The job is a remote job and is open to candidates in USA. Ora is a global ophthalmic drug and device development firm that supports clients across all phases of clinical research. The Manager/Senior Manager of Clinical Documentation will lead and oversee electronic Trial Master File processes, ensuring compliant, accurate, and timely documentation across clinical studies. The role also supports team management, audits, training, quality oversight, process improvement, and document management systems.
Responsibilities
- 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 preparation of documentation and responses to findings
- Contribute to the refinement and implementation of eTMF processes, SOPs, work practices, and templates
- Participate in identifying process gaps, proposing enhancements, and supporting continuous improvement initiatives
- Review eTMF quality metrics for assigned studies, identifying trends and opportunities for corrective action
- Deliver eTMF‑related training to internal teams; support updates to training content as processes evolve
- Assist in communicating procedural updates and best practices across clinical study teams
- Serve as a resource for Good Documentation Practices, TMF Reference Model alignment, and general eTMF guidance
- Monitor eTMF completeness, accuracy, and risk indicators for assigned studies, escalating issues to the Senior Director as needed
- Conduct periodic eTMF quality checks and support documentation reconciliation and close‑out activities
- Support the implementation, maintenance, and user adoption of document management systems (e.g., Veeva Vault, SharePoint)
- Act as an eTMF system super‑user for assigned teams, providing guidance and troubleshooting support
- Ensure compliance with document archiving procedures per SOPs and study scope
- Assist with client qualification or project‑specific audits by preparing required documentation and supporting follow‑up actions
- Ensure team 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
- Demonstrate Ora’s values—kindness, operational excellence, cultivating joy, and scientific rigor
- Responsibilities may shift based on business needs
Skills
- 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/record management systems
- For Sr Manager level : 3 + years of people management experience
- For Manager level : minimum of 1 year people management, team lead or supervisory experience
- Strong understanding of ICH‑GCP, TMF Reference Model, and documentation best practices
- Ability to manage workloads, meet timelines, and operate effectively under time constraints
- Strong analytical and problem‑solving skills with ability to interpret quality trends
- Clear and consistent writing skills; experience contributing to SOPs or process documents
- Demonstrated ability to support organizational change and work effectively in a matrix environment
- Excellent verbal and written communication skills, including presenting to cross‑functional teams
- Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work
- Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy
- Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again
- Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth
- Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world
- Experience with Veeva Vault eTMF (preferred) or other document management systems
Benefits
- Comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
- Flexible PTO & Unlimited Sick Time, in addition to 14 company paid holidays.
- A 401K plan through Fidelity with company match.
- Adoption and fertility assistance.
- 16 weeks paid Parental Leave.
- Company Paid Life & Disability Insurance.
- Remote workspace and wellness purchase reimbursement.
- Employee Assistance Program for you and your family.
- Continued opportunities to grow and develop your career journey.
- Opportunities to work with colleagues across the globe.
- A chance to research new ophthalmic therapies that will impact patients across the globe.
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