Clinical Document Management Specialist I

POSITION TITLE: Clinical Document Management Specialist I

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 600 employees across North America, Europe, Asia, and Latin America.

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 handling such issues independently and with oversight for escalations as needed. This role reports directly to the Senior Director, Clinical Document Management while working in collaboration with various clinical study teams such as Quality Assurance, Operations, Clinical Monitoring, and Biometrics.

What You’ll Do:

• Work within 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 through the document approval process.
• Liaise with project teams who ensures clinical records are filed in a timely manner.
• Perform quality-control (QC) review 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.
• Work within the CDM department and with other teams to promote continual improvement within process and deliverables.
• Adhere to all aspects of Ora’s quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.

  What We Look For:

• Experience Needed for the Role:
  • Bachelor’s Degree 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.

• Additional Skills and Attributes:
  • Prior experience as a Study Coordinator, Clinical Trial Associate, or Clinical Documentation Management is strongly preferred
  • Experience within Veeva Vault is preferred
  • Experience reviewing records for ALCOA+ is strongly preferred
  • Previous exposure to ICH GCP, 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
  • Collaboration skills with teams to achieve project team deliverables.
  • Multi-lingual communication is a plus

• 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.

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.