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.
SENIOR VICE PRESIDENT OF CLINICAL OPERATIONS
Dr. Slater is a motivated and results-driven professional with over 15 years of clinical operations and management experience. Dr. Slater oversees all clinical operations teams at LMK and also serves as general medical advisor for the Leadership Team.
She is a conscientious, outcome-oriented leader with a proven record of successfully guiding projects through to completion. Her driving passion is being able to contribute to the professional development of each of our associates, enabling them to go farther than they thought they could go, and do more than they ever imagined.
EXECUTIVE DIRECTOR OF CLINICAL OPERATIONS
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 five 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 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.