Documentation Manager

Responsibilities

• 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, FDA regulations, ICH guidelines)
• 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 understand their roles and responsibilities in managing documents
• Drive documentation process improvement by identifying, implementing, and managing changes that meet compliance standards and regulatory requirements

Requirements

• 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