Clinical Document Management Specialist II

This is a fully remote position, open to applicants in United States.

📋 Description

• Implement and manage the Ora document management systems (Veeva Vault) along with associated procedures that enable Ora staff to capture, store, retrieve, share, and dispose of electronic records and documents in alignment with SOPs, ICH GCP guidelines, FDA, and EU Directive (and other global regulatory agencies as necessary).

• Oversee documentation to guarantee organization and precision.

• Ensure that clinical records are filed promptly.

• Conduct quality-control (QC) reviews of clinical and regulatory documents submitted for entry into the eTMF and collaborate with project teams to resolve documentation issues.

• Assist in developing workflows and systems to enhance document management, including contributing to SOPs and internal departmental guidance. Support initiatives aimed at improving efficiencies in document management practices and propose enhancements for content management system capabilities.

• Train and actively serve as a Veeva Vault Super-user, providing support and training to team members on processes and eTMF/CTMS software. Aid staff in resolving ad hoc system issues and drive the resolution of identified documentation problems.

• Develop and present training materials to inform trial team staff and CDMS I’s on the usage of Veeva, Good Documentation Practices, Ora processes, and regulatory guidelines.

• Assist the clinical team in the closure and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

• Process and fulfill document requests from internal and external stakeholders for studies archived in the eTMF.

• Generate and review metrics reports intended for periodic review of study files to ensure completeness.

• Identify and classify documents or other electronic content based on characteristics such as security level, function, and metadata.

• Prepare and document changes to eTMF documents and confirm alterations with legal and compliance management staff.

• Assist in developing document or content classification taxonomies to facilitate information capture, search, and retrieval.

• Aid in preparing support documentation and training materials for end users of document management systems.

• Support assigned TMF corrective action plans.

• Responsibilities may vary slightly based on specific business needs.

• Exhibit a clear and sustained demonstration of Ora Clinical’s Values of Customer Service, Leadership, Accountability, Results Oriented, Innovation, and Teamwork.

• Travel requirements are less than 10%.

• Comply with all aspects of Ora’s quality system.

• Adhere to all essential systems and processes necessary at Ora to maintain compliance with Ora’s data integrity, business ethics, and regulatory requirements.

• Consistently demonstrate Ora’s values—prioritizing kindness, operational excellence, cultivating joy, and scientific rigor—as well as their associated behaviors.

⛳️ Requirements

• Bachelor’s degree with at least 3 years of experience in clinical documentation and 3 years of experience with record management systems (eTMF) in the clinical research field or an equivalent combination of work experience, education, and training. Years of experience may be considered in lieu of education.

• Prior experience with Veeva Vault, Montrium, Master Control, Documentum, or Box is highly preferred.

• Familiarity with ICH GCP, DIA TMF Reference Model, and regulatory guidelines/directives.

• Familiarity with eTMF and CTMS software for document management activities.

• Previous experience working in a CRO environment.

• Knowledge of various aspects of clinical trials and regulatory submissions, along with a strong understanding of document management best practices.

• In-depth knowledge of regulatory requirements and ICH/GCP guidelines to support clinical records management.

• Proven ability to work independently, take initiative, complete tasks by deadlines, and mentor other team members.

• Capacity to learn and apply SOPs and process governance regulations related to clinical study documentation.

• Strong attention to detail, document organization skills, ability to establish priorities, and proficiency in scheduling and meeting deadlines to fulfill business demands.

• Ability to communicate effectively at multiple levels both internally and externally and to clearly explain and rationalize responses to issues while guiding study teams, sponsors, and vendors toward the proper and most efficient methods of documentation and documentation maintenance.

• Multi-lingual communication skills are a plus.

🏝️ Benefits

• Well Being: Offering comprehensive healthcare options in Medical, Dental, and Vision starting from day one.

• Flexible PTO & Unlimited Sick Time: Providing you the flexibility to relax and recharge when needed, in addition to 14 company-paid holidays.

• Financial: Competitive salaries paired with a 401K plan through Fidelity with company match.

• Family Support Care: Adoption and fertility assistance is provided along with 16 weeks of paid Parental Leave.

• Company Paid Life & Disability Insurance: Offering peace of mind to ensure you and your family feel secure.

• Remote & Wellness Reimbursement: We’ll reimburse you for supporting your remote workspace and wellness purchases.

• Employee Assistance Program: Regardless of the challenges you're facing, New Directions is here to assist you and your family.

• Career Development Opportunities: Continuous opportunities to grow and advance your career journey.

• Global Team: Opportunities to collaborate with colleagues around the world.

• Impact: A chance to research new ophthalmic therapies that will benefit patients globally.