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Documentation Manager

Clinical Ink -
Remote

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Job Details

Qualifications

Document control experience within pharmaceutical industry
FDA 21 CFR Part 11
ICH guidelines
Bachelor's degree

Full Job Description

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:

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

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