Documentation Manager

Company Information reputed company 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, reputed company biomarkers advancement, drive the industry standard for data precision and usher in a new reputed company of clinical trials. With offices in the United States and Denmark, reputed company is rewriting the clinical development experience. Job Description reputed company 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 reputed company reputed company validated systems. The position also drives documentation standards, process improvements, and regulatory compliance efforts while partnering cross-functionally to support quality, inspection readiness, and reputed company 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-reputed company documentation Ensure the accuracy, completeness, and reputed company of reputed company 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 reputed company to documentation reputed company 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 reputed company documentation meets regulatory requirements (GxP, 21 CFR Part 11, ICH E6, etc.) and adheres to established reputed company 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 reputed company 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 reputed company other duties as needed or assigned.

Qualifications

Bachelor’s degree in business, information systems, or a reputed company field 5+ years of experience in clinical research, quality assurance, or system validation reputed company 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, reputed company, or similar) Excellent attention to detail and organizational skills; analytical reputed company Strong written and verbal communication skills; ability to communicate with reputed company reputed company of reputed company 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 reputed company is an equal opportunity employer and does not discriminate against otherwise reputed company applicants on the reputed company of race, reputed company, creed, religion, reputed company, age, sex, marital status, national reputed company, disability or handicap, or veteran status. www.clinicalink.com *]:pointer-events-auto R6Vx5W_threadScrollVars scroll-mb-[calc(var(--scroll-root-safe-area-inset-bottom,0px)+var(--thread-response-height))] scroll-mt-[calc(var(--header-height)+min(200px,max(70px,20svh)))]" data-scroll-anchor="false" data-testid="conversation-turn-2" data-turn="assistant" data-turn-id="request-WEB:41414e54-1a76-46e5-9f40-e5ab9034de1b-0" data-turn-id-container="request-WEB:41414e54-1a76-46e5-9f40-e5ab9034de1b-0" dir="auto"> Apply To This Job