Clinical research
10 clinical trial consultants
These ten clinical trial consultants advise on clinical operations, clinical development and trial management as independent consultants or through their own consulting firms. A reader can learn how to plan a study, choose and oversee a CRO, and keep sites, vendors and timelines on track.
Professionals to explore
01—10Andrew McGinn
LinkedInExperience: Consultant Associate Director Senior Global Clinical Trial Manager · McGinn Clinical Consultants, LLC
Consultant Associate Director Senior Global Clinical Trial Manager at McGinn Clinical Consultants, LLC since 2002, and former Associate Director, Project Management at Parexel International (2002). His profile says he helps biotech and pharmaceutical organizations move oncology, rare disease and specialty programs from protocol concept to NDA, and lists CRO and vendor oversight among his areas.
Jane Knudson
LinkedInExperience: Clinical Development and Operations Consultant · Knudson Associates, LLC
Clinical Development and Operations Consultant at Knudson Associates, LLC since 2003, with Clinical Consultant engagements listed at KaloBios (2010–2011), InterMune (2009–2010), FibroGen, Inc. (2009) and Talima Therapeutics (2008–2009). Her profile describes directing research from protocol development through final report on large projects using CROs.
Jennifer Stillman
LinkedInExperience: Clinical Trial Consultant · Stillman Clinical Solutions
Clinical Trial Consultant at Stillman Clinical Solutions since 2026; her profile says she founded the firm to help sponsors and biotech companies build, launch and scale clinical programs. Former Strategic Delivery Director at Flourish Research (2025–2026), Sr. Director, Strategic Feasibility at Caidya (2022–2025) and Director, Project Delivery, Hematology Oncology Therapeutic Unit at PPD (2021–2022).
Lisa Gott
LinkedInExperience: Independent Clinical Operations Consultant · Gott Clinical Trial Consultants, LLC
Independent Clinical Operations Consultant at Gott Clinical Trial Consultants, LLC since 2016, and former Clinical Operations Lead (Independent Consultant) at Lyric Pharmaceuticals, Inc. (2017–2018). Her profile says she provides clinical operations and medical-clinical affairs consulting to pharmaceutical, biotechnology and medical device clients, including clinical-stage companies with limited personnel.
Meredith Schiller
LinkedInExperience: Independent Clinical Development Consultant · Meredith Schiller Consulting
Independent Clinical Development Consultant at Meredith Schiller Consulting since 2020, and former Clinical Operations Consultant at BioBridges (2015–2020) and Director Clinical Operations at Acceleron Pharma (2014–2015). Her profile lists expertise in clinical program management, study design, SOP writing, vendor oversight, GCP auditing, US and EU regulatory submissions and BIMO inspections.
Mikhail Chkolnik, MD
LinkedInExperience: Principal Consultant, Clinical Research & Trial Execution · Self-employed / Chkolnik Consulting LLC
Principal Consultant, Clinical Research & Trial Execution at Chkolnik Consulting LLC since 2026, and former Associate Director, Clinical Operations at Vericel Corporation (2021–2026). His profile says he works with life science organizations on clinical trial strategy and execution, focusing on early-stage programs where design choices and operational execution determine data quality.
Sara Weiss
LinkedInExperience: Senior Clinical Operations Consultant · SWW Clinical Consulting
Senior Clinical Operations Consultant at SWW Clinical Consulting, a role listed since 2002. Former Senior Vice President Clinical Operations at Verismo Therapeutics (2021–2024), SVP Clinical Operations at Syntimmune (2015–2017) and Senior Vice President Clinical Operations at Kadmon, a Sanofi Company (2011–2015). Her profile describes designing, setting up and executing large and small trials at domestic and international sites.
Shelly Bustion-Diab
LinkedInExperience: Self-employed, freelance clinical operations expert · Bliss Consulting Sàrl
Self-employed, freelance clinical operations expert at Bliss Consulting Sàrl since 2013; her profile describes hands-on consulting for pharma, academia and CROs, with expertise in clinical trial and program management. Former Director, Site Head Geneva, Clinical Trial Management Early Development (2011–2012) and Associate Director, Clinical Trial Management Early Development (Ph I to POC) (2009–2011) at Merck Healthcare.
Simon Roitt
LinkedInExperience: Consultant Clinical Development and Clinical Operations · Freelance
Freelance Consultant Clinical Development and Clinical Operations since 2024. Former VP Head of Clinical Operations (2021–2024) and Program Development Leader (2022–2024) at Noema Pharma, and Director Clinical Program Operations at Eli Lilly and Company (2019–2021). His profile describes expertise in clinical program and study management and vendor oversight, helping biotech and pharma deliver results.
Tania Johnstone Issa
LinkedInExperience: Independent Consultant in Clinical Trials Operations, Technologies, & Compliance · Seattle WA, Self Employed
Independent Consultant in Clinical Trials Operations, Technologies, & Compliance (self-employed) since 2008, and Consultant at Insite QA (formerly cGXP Consultants) since 2008. Former Clinical Research Consultant at Clinimetrics (1994–1999). Her profile describes consulting across global clinical research operations and GCP compliance, from Phase I–IV single-center to multi-national trials involving medical devices, biologics and pharmaceuticals.
Choose the right perspective
Match the consultant's background to your stage and need: someone with sponsor-side clinical operations leadership suits building a trial team, while a consultant focused on compliance or trial management suits inspection readiness or rescuing a delayed study. Ask which trial phases and therapeutic areas they have worked in before engaging them.
Questions to take into the conversation
- 01How do you select a CRO and set up oversight so that problems surface early?
- 02What do you check in a protocol to make sure it is operationally feasible at sites?
- 03How do you prepare a sponsor for a regulatory inspection of a clinical trial?
About this directory
This is a professional research starting point based on business profile data retrieved on . Titles and companies reflect that source snapshot and may describe past or present roles. Check the linked profiles for current details. Inclusion does not imply Instant Expert membership or availability.
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