Clinical Documentation Manager

POSITION TITLE: Manager/Senior Manager, Clinical Documentation Management

DEPARTMENT: Clinical Document 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 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 400 employees across North America, Europe, Asia, and Latin America.

The Role:

The Manager/Senior Manager of Clinical Documentation (eTMF) will support the operational management, quality oversight, and continuous improvement of Ora’s electronic Trial Master File (eTMF) processes. Reporting to the Senior Director of Clinical Documentation, this role contributes to the day‑to‑day leadership of the Clinical Documentation team and ensures eTMF activities are executed in alignment with regulatory requirements, internal standards, and study timelines.

The Manager/Senior Manager partners closely with cross‑functional study teams—including Clinical Monitoring, Project Delivery, Biometrics, and Quality Assurance—to ensure accurate, timely, and compliant documentation throughout the lifecycle of Ora’s clinical studies.

What You’ll Do:

Team Leadership & Operational Management

• 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.

Compliance:

• 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.

Process Improvement & Quality Oversight:

• 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.

Training & Cross‑Functional Support:

• 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.

Clinical Documentation Oversight:

• 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.

System & Records Management:

• 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.

Audit & Client Support:

• 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.

Additional Responsibilities:

• 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.

What We Look For:

• Experience needed for the Role:
  • 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
• Additional Skills & Attributes:
  • Experience with Veeva Vault eTMF (preferred) or other document management systems.
  • 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.

Competencies and Personal Traits:

• What We Do:
  • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
• How We Do It:
  • IQ, EQ and SQ: 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.
  • Clear and Direct Communication, Feedback and Conflict Resolution: 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.
• Why We Do It:
  • 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. At Ora, we are creating vision beyond what we see.

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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