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.
founder, president & ceo
Sholeh is widely recognized as an innovative professional with over 20 years of experience in the Clinical Research Industry. Her expertise and knowledge in all areas of study management and the operational aspects of clinical trial and document management processes has made her a leader and trusted expert in this field.
Her experience includes: eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations/CRO management, electronic document management, regulatory submissions, quality control processes and implementation, IRB communications, and regulatory inspection participation and preparation.
Sholeh is the Facilitator of the Metric Champion Consortium’s (MCC) TMF initiative, a cross-industry working group defining standard metrics and key risk indicators that support the TMF.
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.
EXECUTIVE DIRECTOR, TMF EDUCATION
Jackie is a Lean Six Sigma Green Belt certified clinical research professional with over 15 years of experience in clinical trial coordination and process improvement within the healthcare, biotech, and pharmaceutical industries. For the past nine years, her dedicated focus has been on all things Trial Master File (TMF).
Her experience includes oversight of eTMF implementations, coordination of large migration and integration projects, development of robust metrics and training programs, enhancement and development of TMF processes, and extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections. Jackie is also the creator and director of the company's TMF University, a comprehensive education and training program specifically designed to enhance the knowledge and elevate the competencies of those who work in the TMF environment.
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.