Experienced Clinical Operations & TMF Expert | Regulatory Compliance | Study Start-Up | Process Optimization
With over a decade of experience in clinical operations, TMF management, and regulatory compliance, I help biotech and pharmaceutical companies streamline clinical trial processes, ensure audit readiness, and drive operational excellence.
As the Founder & Principal Consultant of LJW Clinical Solutions, LLC, I provide expert guidance in:
✔ TMF Management – Ensuring compliance, completeness, and inspection readiness
✔ Regulatory Compliance – Adhering to ICH/GCP, FDA, and global regulatory standards
✔ Study Start-Up – Site activation, regulatory submissions, and stakeholder coordination
✔ Contracts & Budgets – Negotiation, oversight, and financial compliance
✔ Process Optimization – Developing SOPs, workflows, and efficiency strategies
✔ Clinical Operations Support – CRA management, quality assurance, and risk mitigation
I have successfully led cross-functional teams, improved trial efficiency, and implemented best practices in study management. My background includes leadership roles in CROs, biotech, and pharma, where I specialized in TMF oversight, study start-up, and regulatory documentation.
Passionate about delivering high-quality clinical research solutions, I work with organizations to enhance compliance, reduce risk, and optimize trial performance.
💡 Let’s connect! I’m open to consulting opportunities, collaborations, and discussions on clinical research advancements.
Company Details
- Founded
- -
- Address
- Raleigh, Nc 27601, Us
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Keywords
- TMF Management, Regulatory Compliance, Process Optimization, Clinical Operations Support, Study & Site Contracting, Study Start Up & Site Activation.
- HQ
- Raleigh, NC
Ljw Clinical Solutions, Llc Questions
Ljw Clinical Solutions, Llc's LinkedIn profile is https://www.linkedin.com/company/ljwcsolutions
Ljw Clinical Solutions, Llc's industry is
Biotechnology Research
Ljw Clinical Solutions, Llc's top competitors are
Precision For Medicine,
Ice Consulting, Llc,
Montrium,
Clinical Resource Network (Crn),
Neovation Consultancy Services,
Fhi 360,
Just In Time Gcp.
Ljw Clinical Solutions, Llc's categories are Biotechnology Research
Ljw Clinical Solutions, Llc's founding year is 2025
