Senior Manager, TMF Operations & Process Excellence – 12 Month Contract, 1.0 FTE

The Senior Manager, TMF Operations & Process Excellence serves as a key operational and process leader for the organization’s Trial Master File (TMF) and electronic Trial Master File (eTMF) ecosystem.As stated in the document, the role “acts as a strategic business partner across Clinical Operations, Clinical Development, Regulatory Affairs, Clinical Supply, Safety, Legal, Quality Assurance, Information Technology, and external partners”.

This position is responsible for ensuring TMF processes, systems, and governance activities remain compliant, inspection?ready, efficient, and aligned with evolving business needs. It combines TMF expertise, eTMF system lifecycle management, process excellence, stakeholder engagement, training, inspection readiness, and continuous improvement.

Key Responsibilities

TMF Governance & Inspection Readiness

• Provide TMF governance support across clinical studies through training, consultation, TMF health monitoring, issue identification, and collaboration with study teams and CROs.The document notes responsibilities such as “maintaining clear accountability for TMF content, quality, and periodic review execution”.
• Monitor TMF quality, completeness, timeliness, and inspection readiness.
• Use outputs from TMF reviews, audits, inspections, and metrics to identify risks, training needs, process gaps, and system enhancement opportunities.
• Partner with study teams and Quality Assurance to recommend risk mitigation strategies and support remediation.
• Support audit and inspection preparation and participate in inspections as needed.
• Promote TMF best practices and a culture of inspection readiness.
• Support development and maintenance of TMF plans, guidance documents, templates, and governance tools.

eTMF System Lifecycle Management

• Support business ownership of the eTMF platform throughout its lifecycle.
• Coordinate change controls, enhancement requests, configuration updates, system releases, and business-driven improvements.
• Translate business requirements into effective technical solutions.
• Support impact assessments, UAT, implementation planning, deployment, and post?release monitoring.
• Participate in system governance and roadmap planning.
• Monitor system performance and user feedback.
• Manage issue resolution with internal and external stakeholders.
• Oversee configuration change management and user access governance, ensuring compliance with procedures and security principles.

Process Excellence & Continuous Improvement

• Identify opportunities to improve TMF processes, workflows, controls, and user experience.
• Lead or support process improvement initiatives across development functions.
• Analyze operational trends, recurring issues, inspection observations, and stakeholder feedback to drive sustainable improvements.
• Develop practical solutions balancing compliance and operational efficiency.
• Support evolution of TMF governance frameworks and operating models.

Documentation & Procedural Governance

• Author, review, and maintain SOPs, work instructions, guidance documents, templates, and training materials.
• Support implementation of procedural changes across functions.
• Ensure TMF and eTMF documentation remains current and aligned with regulatory expectations.
• Collaborate to simplify, harmonize, and standardize procedures.

Stakeholder Management

• Serve as the primary TMF and eTMF subject matter expert.
• Partner with Clinical Operations, Clinical Development, Regulatory Affairs, Clinical Supply, Safety, Legal, Quality Assurance, IT, and external partners.
• Build strong relationships with study teams, functional leaders, CROs, and system vendors.
• Facilitate alignment across stakeholders with differing priorities.
• Gather feedback, identify root causes, and translate findings into actionable improvements.
• Represent business needs in system enhancement and governance discussions.

Cross?Functional Leadership

• Lead discussions on TMF processes, eTMF capabilities, inspection readiness, and operational challenges.
• Facilitate decision?making while balancing compliance, business needs, user experience, and efficiency.
• Build consensus across internal and external stakeholders.
• Escalate significant risks and strategic considerations when appropriate.
• Act as a trusted advisor to study teams and functional stakeholders.

Training & User Support

• Deliver training sessions for new and existing users.
• Develop role?based training materials and guidance documents.
• Provide coaching and support to study teams and business stakeholders.
• Promote adoption of TMF best practices.
• Support onboarding related to TMF processes and systems.
• Maintain a library of role?based training content and ensure updates following system or process changes.
• Plan and execute training rollouts for system enhancements and new features.
• Serve as the first point of escalation for eTMF technical issues, coordinating resolution with IT or vendors.

Reporting & Metrics

• Define, build, and maintain a TMF metrics framework within the eTMF system.The document describes this as “identifying the right reports and dashboards to meaningfully track completeness, timeliness, filing accuracy, and inspection readiness”.
• Produce and distribute regular TMF status reports.
• Use reporting outputs to identify patterns, escalate risks, and inform continuous improvement initiatives.

Vendor & Partner Oversight

• Collaborate with external partners supporting the TMF ecosystem.
• Support governance meetings, operational reviews, and improvement initiatives.
• Track action items and ensure timely execution.
• Contribute to vendor performance monitoring and oversight.

Required Qualifications

• Bachelor’s degree in Life Sciences, Clinical Research, Quality, Information Systems, or related field.
• Significant experience in TMF management, eTMF operations, clinical operations, clinical development, quality assurance, or clinical systems.
• Experience with Veeva Vault eTMF or comparable platforms.
• Strong understanding of TMF requirements, inspection readiness, and TMF governance.
• Experience with system enhancements, releases, testing, and change management.
• Knowledge of GCP, ICH guidelines, TMF Reference Model, and regulatory requirements.
• Experience collaborating with CROs and cross?functional stakeholders.
• Ability to manage multiple priorities in a dynamic environment.
• Experience managing user access in validated GxP systems.
• Experience building system?generated reports and dashboards.