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Associate Director, Trial Master File Operations
Madrigal Pharmaceuticals. Lead day-to-day TMF operational strategy, oversight, inspection readiness, sponsor QC oversight, metrics management, issue escalation, and governance .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in TMF operations, ensuring compliance with regulatory expectations and maintaining inspection readiness. Proficient in managing TMF resources, metrics, and quality oversight while driving continuous improvement in TMF processes.
Highest-signal resume keywords
TMF Operations ManagementETMF OversightGCP KnowledgeVeeva Vault eTMF ExperienceInspection Readiness
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
TMF StrategyClinical DocumentationMetrics ManagementQuality ReviewIssue ResolutionGovernanceTMF Process AlignmentRisk-Based QC ActivitiesContinuous ImprovementTMF Health Monitoring
Soft Skills
Organizational SkillsCommunication SkillsStakeholder ManagementEscalation SkillsCompeting Priorities Management
Tools & Technologies
ETMF SystemsVeeva VaultCDISC TMF Reference Model
Industry Keywords
Clinical ResearchFSPCROInspection ReadinessSponsor Oversight
Tech Stack
Tools & technologiesGoogle Cloud PlatformVault
About the role
Key responsibilities & impact- Lead day-to-day TMF operational strategy, oversight, inspection readiness, sponsor QC oversight, metrics management, issue escalation, and governance
- Lead TMF operations across assigned studies, programs, or the enterprise TMF model
- Ensure documentation is complete, accurate, timely, and inspection-ready
- Manage and oversee FSP TMF resources, including workload management, performance expectations, issue resolution, quality review, and operational risk escalation
- Lead or support periodic TMF reviews, risk-based QC activities, completeness assessments, and inspection-readiness reviews
- Ensure TMF processes align with the TMF Plan, study milestones, the CDISC TMF Reference Model, internal procedures, and applicable regulatory expectations
- Support inspection and audit preparation, including TMF storyboarding, document retrieval readiness, issue remediation, and response support
- Establish and maintain TMF QC oversight processes, including sponsor QC review, sampling strategy, quality issue tracking, and remediation follow-up
- Partner with Clinical Operations, Study Teams, Quality, Regulatory, Clinical Systems, and vendors
- Monitor TMF health, completeness, timeliness, quality, and inspection-readiness metrics
- Lead TMF issue management and escalation, ensuring gaps, overdue records, quality findings, and systemic risks are documented, assigned, tracked, and resolved
- Drive adoption of TMF processes, tools, templates, naming conventions, metadata expectations, and quality standards
- Partner with the Clinical Capabilities Innovation Lead on compliant, human-overseen AI-enabled TMF workflows
- Identify continuous improvement opportunities across TMF operations, QC, metrics, governance, vendor oversight, and inspection readiness
Requirements
What you’ll need- Bachelor’s degree required; degree in life sciences, health sciences, clinical research, or related field preferred
- Strong experience in TMF operations, eTMF oversight, clinical documentation, clinical operations, or inspection readiness
- Experience managing or overseeing FSP, CRO, or vendor-supported TMF activities
- Strong knowledge of GCP, essential records, inspection readiness, sponsor oversight, and TMF health expectations
- Experience with eTMF systems required; Veeva Vault eTMF experience strongly preferred
- Familiarity with the CDISC TMF Reference Model preferred
- Experience developing or managing TMF metrics, QC processes, issue logs, remediation plans, and governance materials
- Strong organizational, communication, escalation, and stakeholder management skills
- Ability to manage competing priorities across studies, vendors, and internal stakeholders
- Inspection, audit, or health authority readiness experience strongly preferred
Benefits
Comp & perks- Base salary
- Bonus
- Equity
- Flexible paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- Life/disability insurance
- 401(k) traditional, Roth, and employer match
- Supplemental life insurance
- Legal services
- Mental health benefits through the Employee Assistance Program for employees and their family
- Reasonable accommodations throughout the hiring process