Clinical Document Management Specialist I

POSITION TITLE:Clinical Document Management Specialist I

DEPARTMENT: Operations

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 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: Ora's Clinical Documentation Management Specialists I (CDMS I) is responsible for the management, quality and oversight of the electronic Trial Master File (eTMF) associated with all phases of assigned clinical trials (i.e., set-up through final transfer / archival). CDMS I's are crucial for ensuring, with oversight, Ora's clinical teams operate in compliance with SOPs and processes, study sponsor expectations and all applicable regulations. This role will focus on the quality of documents being uploaded to the eTMF and monitoring compliance to the TMF relative to inspection readiness and handle such issues independently and with oversight for escalations as needed. This role reports directly to the Manager, Clinical Operations Staff while working in collaboration with carious clinical study teams such as Quality Assurance, Chemical Manufacturing Control, and Medical Devices.

What You'll Do:

• Implement and administer Ora Document Management systems (Veeva Vault) and related procedures that allow Ora staff to capture, store, retrieve, share, and destroy electronic records and documents in a manner consistent and in accordance with SOPs, ICH GCP guidelines, FDA, and EU Directive (and other global regulatory agencies as needed).
• Manage documentation to ensure organization and accuracy.
• Ensures clinical records are filed in a timely manner.
• Perform quality-control (QC) review of clinical and regulatory documents submitted for entry into the eTMF and liaise with project teams towards documentation issue resolution.
• Assist the clinical team in the close-out and archiving of Clinical Documentation and reports according to the scope of work and standard operating procedures.
• Generate/review metrics reports intended as periodic review of study files for completeness.
• With oversight, identify and classify documents or other electronic content according to characteristics such as security level, function, and metadata.
• Supports assigned TMF corrective action plans.
• Responsibilities may differ slightly from the above based on specific needs of the business.
• Clear and sustained demonstration of the Ora Clinical's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
• Travel Requirements less than 10%

What We Look For:

• Experience Needed for the Role:
  • Bachelor'sDegree with a minimum of 1-year equivalent training and/or work experience in a medical or research field, including course work. Years of experience may be considered in lieu of education.
• Preferred Qualifications:
  • Prior experience as a Study Coordinator, Clinical Trial Associate, or Clinical Documentation Management is strongly preferred
  • Previous exposure to ICH GCP, DIA TMF Reference Model and regulatory guidelines/directives.
  • Background conducive with readily becoming familiar with eTMF and CTMS software for Document Management activities.
  • Ability to learn and apply SOPs and process governance regulations pertaining to clinical study documentation.
  • Requires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines in order to meet business demands.
  • Exceptional verbal and written communication skills with demonstrated ability to be flexible and adapt quickly.
• 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 to learn 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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