Associate Director, Document Management, Inspection Readiness

Corbus Pharmaceuticals

Associate Director leading document management and inspection readiness at Corbus Pharmaceuticals. Driving compliance and operational excellence through strategic document management initiatives.

Posted 6/9/2026full-timeNorwood • Massachusetts • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud PlatformVault

About the role

Key responsibilities & impact

Serve as the business owner and subject matter expert (SME) for document management
Lead document management strategy and continuous improvement initiatives
Act as the primary point of escalation and strategic advisor for document management
Provide leadership and oversight for TMF/eTMF health, compliance metrics, risk identification, issue remediation, and inspection preparedness
Support audits, regulatory inspections, sponsor oversight activities, and vendor qualification efforts
Partner with Quality Assurance to develop, maintain, and improve SOPs, work instructions, guidance documents, and training materials
Oversee document management activities performed by external partners
Lead the administration and optimization of Veeva Vault and other EDMS platforms
Develop and deliver training on EDMS platforms and document management processes

Requirements

What you’ll need

Bachelor's degree in Life Sciences, a scientific discipline, or a related field
Minimum of 10 years’ experience in Clinical Document Management, TMF/eTMF management, Records Management, Clinical Quality, or related GxP-regulated functions with increasing levels of responsibility
Strong working knowledge of Veeva Vault applications, including eTMF; experience with system administration, governance, implementation, and/or migration activities is required
Thorough understanding of global regulatory requirements and industry guidance, including ICH-GCP, FDA, EMA, MHRA, and ALCOA+ principles for data integrity
Strong knowledge of clinical trial documentation and regulatory and manufacturing documentation
Excellent organizational, communication, and stakeholder management skills
Advanced proficiency with Microsoft Office applications

Benefits

Comp & perks

Health insurance
Paid time off
Flexible work arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical Document ManagementTMF managementRecords ManagementClinical QualityVeeva VaulteTMFsystem administrationgovernanceimplementationmigration activities

Soft Skills

leadershiporganizational skillscommunication skillsstakeholder management