At LMK, we understand how important the TMF is to a clinical operation as well as providing step-by-step documentation of the clinical trial process as well as facilitating, and not hindering, the audit process during inspections. Clinical research professionals who are responsible for creating TMF’s should be mindful of this always and our leaders at LMK help us accomplish this goal everyday. Our TMF Professionals are lead by a team with over 40 years of clinical trial experience and know-how. Get to know our leaders today and allow us to make your next clinical trial easier. 

Our Leadership Team

Sholeh Ehdaivand

President & CEO

Sholeh Ehdaivand is President and CEO of LMK Clinical Research Consulting, a certified women-owned TMF consulting and services company. She is also 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. She is recognized as an innovative professional with over 15 successful years of experience in the Clinical Research Industry. Her expertise and knowledge in all areas of study management and operational aspects of the clinical trial and document management processes has made her a leader and trusted expert. Her experience includes the TMF reference model member, 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

Shahrzad Slater

Senior Vice President of Clinical Operations​

Shahrzad Slater is the Senior Vice President of Clinical Operations at LMK Clinical Research Consulting, a certified women-owned TMF consulting and services company. An Innovative and energetic professional with over 13 years of clinical and management experience. Recognized as a motivated, flexible, and team-oriented leader, Dr. Slater oversees all clinical operations in process at LMK.  A conscientious manager who can effectively collaborate with, manage and motivate teams. A proactive leader & results driven with a proven record of successfully seeing projects through to completion.

 

Jackie Morrill

Executive Director of Clinical Operations

Jackie Morrill is the Executive Director of Clinical Operations at LMK Clinical Research Consulting, a certified women-owned TMF consulting and services company. She is a Lean Six Sigma Green Belt certified clinical research professional with over a decade 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 electronic TMF (eTMF) implementation, coordination of a 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.

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