TMF/eTMF Lead — Clinical Records Management

Clinical Dynamix, Inc.; Waltham (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Clinical Dynamix, Inc. is seeking a Senior Manager/Associate Director, Records Management to lead TMF/eTMF operations across therapeutic areas. You will implement systems, drive process improvements, and train staff to ensure GCP compliance and inspection readiness within Clinical Operations.

The role includes overseeing vendor relationships, conducting sponsor oversight reviews, and guiding the records management team to meet timelines while maintaining quality and regulatory adherence.

Qualifications

• Minimum 5–6+ years in Clinical Operations within pharma or medical devices.
• 5+ years’ TMF/records management experience.
• At least 2 years of people management experience.
• Experience with health authority inspections preferred.
• Strong collaboration and communication skills.
• Ability to manage multiple priorities.
• Proficiency in MS Office and MS Project.

Responsibilities

• Lead the records management team to meet goals and timelines in compliance with SOPs.
• Serve as TMF/eTMF SME; provide best practices and training development.
• Oversee TMF/eTMF systems, oversight plans, and templates.
• Perform sponsor oversight reviews of TMF/eTMF for quality deliverables.
• Manage CROs/Vendors and mitigate risk per ICH/GCP guidelines.
• Contribute to cross-functional study teams ensuring GCP compliance.
• Assist with site/sponsor audits and inspection readiness planning.
• Support clinical operations projects and maintenance of clinical systems.
• Manage eTMF migration when TMF is with external vendor.
• Travel up to 10% for meetings, audits, conferences.

Skills

Team leadership

Regulatory compliance

GCP & TMF knowledge

Vendor management

Training development

Project management

Communication

Organizational skills

Cross-functional collaboration

Education

Bachelor's degree in Health or Life Sciences

Advanced degree preferred (MS/PhD)

Tools

Microsoft Office

Microsoft Project

Job description

Clinical Dynamix, Inc. is seeking a Senior Manager/Associate Director, Records Management to lead TMF/eTMF operations across therapeutic areas. You will implement systems, drive process improvements, and train staff to ensure GCP compliance and inspection readiness within Clinical Operations.

The role includes overseeing vendor relationships, conducting sponsor oversight reviews, and guiding the records management team to meet timelines while maintaining quality and regulatory adherence.