Jodi Mullin has worked in the medical device industry for over 13 years, with experience spanning a diverse array of therapeutic areas including cardiology, oncology and urology.  She has worked with startups to Fortune 500 companies, partnered with clinical technology providers and spearheaded cross-functional process improvement initiatives.

Jodi has extensive experience with Site management from selection to close-out, including onsite, remote and risk-based monitoring. She is a Certified Clinical Research Associate and member of the Association of Clinical Research Professionals.

In addition to managing NAMSA’s U.S. based Clinical Trial Administrators, Jodi is part of NAMSA’s electronic Trial Master File (eTMF) technical team and recently led the reimplementation of eTMF technology.

Jodi’s early experiences in social work clinical practice, program evaluation and public affairs, laid the groundwork that helps her navigate challenges and coordinate complex systems.

CORE COMPETENCIES

• Recruitment, onboarding and training of clinical research personnel
• Development of Clinical Operations processes
• Leadership of electronic Trial Master File (eTMF) technical team
• Site management from selection to closure including contract and budget negotiation
• Protocol, case report form and regulatory document development
• Data management for Electronic Data Capture (EDC) and paper-based studies, data entry, review and query resolution
• Management of Trial Master Files and Sites Files including report development and presentation of TMF health metrics
• Performance of internal Trial Master File audits and support of Bioresearch Monitoring (BIMO) inspections
• Coordination of Clinical Events Committee, including development of CEC manuals, Adverse Event Review meeting materials and Adverse Event Summaries
• Departmental initiatives including Clinical Technology Roadmap, Diversity and Inclusion in Clinical Trials, Risk Based Monitoring working group and Associate onboarding

RECENT PROJECTS

• Managed the second generation implementation of Veeva Vault eTMF with advanced functionality and operational process improvements
• Managed the transfer of a 2000+ document TMF between systems for a global 15+ site study