About Us
At LMK, we believe in ensuring our clients become the first-to-market through speed and readiness of the Trial Master File (TMF).
Years of experience and knowledge of regulations empowers us to remove the burden of the TMF with calm, empathetic confidence and a positive mindset. Our team of TMF Professionals is composed of highly skilled and experienced individuals who are committed to elevating the role of the TMF in the clinical trial space and working collaboratively with our clients to ensure their TMF is working as a tool for success.
All LMK TMF Professionals are graduates of LMK's original TMF University and are Barnett GCP Certified TMF Auditors.
Leadership Team
DIRECTOR, CLINICAL OPERATIONS
Janice has over 15 years of experience in clinical research (pharmaceutical, biotech and CRO), providing direction and leadership in the clinical operations and document management areas. Her experience includes strategic planning and oversight of TMF services such as eTMF implementation, process development, business/technology alignment, TMF management, content migration, audit and regulatory inspection readiness, risk management, CAPA implementation, KPI/metrics development, line management, resource and budget planning, and cross-functional team leadership. Her results driven approach and continuous improvement mindset are proven for clients success.
ASSOCIATE DIRECTOR, CLINICAL OPERATIONS
Ruby began her career in TMF management in 2005 at a large CRO amidst their global records management centralization project. She has worn many hats during her 15+ year tenure within this specialized field, including (but not limited to): Subject Matter Expert, Steering Committee Member, Help Desk, Process Developer, Systems Tester, and Trainer.
She has been a pilot participant/contributor for three major eTMF upgrades/implementations and has provided TMF process training on three continents. Her current certifications include: GCP, Project Management Lean Process, Clinical Research Auditing, and Qualified TMF Manager. Ruby is also a Six Sigma White Belt.
BUSINESS OPERATIONS MANAGER
Jessica Luhrsen is currently a business operations manager at LMK, with eight years of experience working alongside the executive team. Jessica has worn many hats during her tenure, from administration, recruitment, HR and now operations. Her experience includes overseeing operations and recruitment, aligning departments, and streamlining processes to drive improvement and overall performance of LMK.