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AI Summary
Manage the full lifecycle of study operations documentation, ensuring all testing and validation records are accurate, compliant, and audit-ready. Drive documentation standards, process improvements, and regulatory compliance while partnering cross-functionally to support inspection readiness.
Company Information
Clinical Ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in the United States and Denmark, Clinical Ink is rewriting the clinical development experience.
Job Description
Clinical Ink is seeking a Documentation Manager to join our Study Operations team based in the United States. In this role, you will be responsible for managing the full lifecycle of study operations documentation, ensuring testing and validation records are accurate, compliant, version controlled, and audit ready within validated systems. The position also drives documentation standards, process improvements, and regulatory compliance efforts while partnering cross-functionally to support quality, inspection readiness, and continuous improvement across the Study Operations organization. The Documentation Manager's responsibilities include:
Clinical Ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in the United States and Denmark, Clinical Ink is rewriting the clinical development experience.
Job Description
Clinical Ink is seeking a Documentation Manager to join our Study Operations team based in the United States. In this role, you will be responsible for managing the full lifecycle of study operations documentation, ensuring testing and validation records are accurate, compliant, version controlled, and audit ready within validated systems. The position also drives documentation standards, process improvements, and regulatory compliance efforts while partnering cross-functionally to support quality, inspection readiness, and continuous improvement across the Study Operations organization. The Documentation Manager's responsibilities include:
- Document Lifecycle Management
- Collaborate with Study Quality, Project Design, and other Study Operations teams to draft, format, and finalize study build-related documentation
- Ensure the accuracy, completeness, and integrity of all testing and validation documentation including but not limited to test plans, test cases, scripts, traceability matrices, and summary reports
- Track and monitor document status (i.e., draft, review, fully executed) to ensure timelines and expectations are met; report metrics related to documentation
- Oversee version control and store documents systematically in validated document management systems; ensure readiness for future retrieval
- Review, address, and repair historical study build documentation
- Compliance and Quality Assurance
- Ensure all documentation meets regulatory requirements (GxP, 21 CFR Part 11, ICH E6, etc.) and adheres to established Clinical Ink standard operating procedures
- Prepare documentation for audits and inspections, maintaining version control and accessibility
- Identify deficiencies and inconsistencies in documentation; work with Compliance to implement corrective and preventative actions (CAPAs) to address issues
- Documentation Standards and Procedures
- Review, implement, and manage processes around documentation to ensure timely completion and accuracy
- Establish standard document templates, forms, etc. and enforce best practices across the Study Build team
- Train new and existing team members on documentation standards, best practices, tools, and regulatory expectations
- Ensure all team members under documentation processes and their roles and responsibilities in managing documents
- Drive documentation process improvement by identifying, implementing, and managing changes that meet compliance standards and regulatory requirements
- Perform other duties as needed or assigned.
Qualifications
- Bachelor’s degree in business, information systems, or a related field
- 5+ years of experience in clinical research, quality assurance, or system validation within a CRO, pharmaceutical, or biotech environment
- Minimum of 2 years in a documentation management role
- Strong working knowledge of GxP, FDA regulations, and ICH guidelines
- Experience with computerized system validation (CSV) and software testing documentation
- Proficiency with document management systems (e.g., VeevaVault, MasterControl, or similar)
- Excellent attention to detail and organizational skills; analytical mindset
- Strong written and verbal communication skills; ability to communicate with all levels of internal and external personnel
- Ability to manage multiple projects and deadlines in a fast-paced environment
- Certification in Quality (e.g., ASQ CQA) or Clinical Research (e.g., ACRP, SOCRA) preferred
- Experience supporting regulatory inspections (FDA, EMA, etc.) and client audits preferred
- Familiarity with risk-based validation approaches (i.e., CSA) preferred
Additional Information
Clinical Ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.
www.clinicalink.com
Clinical Ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.
www.clinicalink.com
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