10 clinical research consultants
Oncology, rare disease, pulmonary, hematology and medical device programs all show up in the work of these clinical research consultants, the longest-serving of whom has consulted for sponsors since 1993. Eight are based in the U.S. and two in Europe, in the Netherlands and the Stockholm area. They suit a sponsor planning a first trial, choosing and overseeing a CRO, or getting trial records ready for a regulatory inspection.
Professionals to explore
Andrew McGinn
LinkedInExperience: Consultant Associate Director Senior Global Clinical Trial Manager · McGinn Clinical Consultants, LLC
Andrew McGinn has consulted through McGinn Clinical Consultants, LLC since 2002, helping biotech and pharmaceutical companies move oncology, rare disease and specialty programs from protocol concept to NDA, and has directed Phase I-IV global trials across more than 14 oncology programs. Andrew was Associate Director, Project Management at Parexel International (2002) and Clinical Research Manager at DuPont Pharmaceuticals (1995-2001).
Is this you? Claim your profile and get paid for calls.
Annemarie Kleefstra
LinkedInExperience: Freelance Clinical Research and Development Consultant · ClinRes Expertise
Annemarie Kleefstra founded ClinRes Expertise in January 2023 and works there as a Freelance Clinical Research and Development Consultant, with 18 years of international clinical project management at sponsors and CROs plus SOP creation and process improvement. Annemarie also holds Senior Clinical Development Strategist roles at Seuss+ and AnRes Clinical (both since 2023) and was Director Clinical Operations at STipe Therapeutics (2023-2024).
Is this you? Claim your profile and get paid for calls.
Béatrice Selin
LinkedInExperience: Senior Clinical Research Consultant · Nordic Trials Consulting AB
Béatrice Selin, in the Stockholm area, has been Senior Clinical Research Consultant and Managing Director at Nordic Trials Consulting AB since 1999. Béatrice was also a Senior Clinical Research Consultant at Pfizer (1999-2004) and Founder of Biopharma Associates AB (2008-2012), which makes Béatrice a fit for questions on running trials in the Nordic countries.
Is this you? Claim your profile and get paid for calls.
Debra Lounsbury
LinkedInExperience: Founder & CEO · Synergy Clinical Research Consulting LLC
After more than a decade at BioMarin Pharmaceutical Inc., most recently as Senior Director Clinical Sciences Late Stage Clinical Development (2021-2024), Debra Lounsbury founded Synergy Clinical Research Consulting LLC in 2024 and serves as its Founder & CEO, focused on patient-centric trials for unmet medical needs. Debra's earlier BioMarin titles were Sr. Principal Scientist Clinical Medical Monitor (2020-2021) and Principal Scientist Clinical Medical Monitor (2009-2020).
Is this you? Claim your profile and get paid for calls.
Dr. Marianne Sierra, Ph.D., MBA, CCRP
LinkedInExperience: Founder & Principal Consultant - Global · Sierra Clinical Strategy & Consulting LLC (SC²)
Dr. Marianne Sierra, Ph.D., MBA, CCRP has been Founder & Principal Consultant - Global at Sierra Clinical Strategy & Consulting LLC (SC²) since 2010 and cites over 20 years advancing programs in neuroscience, cardiovascular, medical device, rare disease and oncology. Marianne is also Associate Medical Director at Summit Clinical Research (since 2024) and was Manager, Neuroscience Clinical Operations at Tenet Healthcare (2015-2024), a fit for sponsor and site alignment questions.
Is this you? Claim your profile and get paid for calls.
Jennifer Cockerham
LinkedInExperience: Owner Clinical Research Consultant · SoCal Clinical Consulting Services, LLC
Jennifer Cockerham has been Owner Clinical Research Consultant at SoCal Clinical Consulting Services, LLC since 2014 and cites over 20 years on pharmaceutical and medical device trials, from pre-IND to post-marketing. Consulting engagements include La Jolla Pharmaceutical Company (2015-2021), The Prostate Cancer Clinical Trials Consortium (PCCTC) (2017-2020), Conatus Pharmaceuticals (2008-2016) and ONCOtherapeutics (2006-2008).
Is this you? Claim your profile and get paid for calls.
Katherine Bell
LinkedInExperience: Principal Consultant, Clinical Development and Operations · Lior Clinical Consulting, LLC
Katherine Bell is Principal Consultant, Clinical Development and Operations at Lior Clinical Consulting, LLC (since 2025) and describes working in both sponsor and CRO environments across pharmaceutical, medical device and biologic products. Engagements include Consultant, Lead Study Manager at Ultragenyx (2025-2026) and Consultant, Clinical Business Operations at Immunovant (2024), after Sr. Manager Clinical Program Manager, Clinical Trials at Emergent BioSolutions (2021-2023).
Is this you? Claim your profile and get paid for calls.
Kevin Corkery
LinkedInExperience: Former Principal · Clinical Research Consultant
Kevin Corkery describes managing three pulmonary development programs through clinical development to FDA approvals and has held roles including Principal Fellow Global Program Lead at Novartis (2009-2019) and Program Head Senior Director at Nektar Therapeutics (2004-2008). Kevin has worked as a Principal clinical research consultant since 2022, and also from 2018 to 2021, with a stint as Vice President Clinical Operations at Respira Therapeutics, Inc. (2021-2022).
Is this you? Claim your profile and get paid for calls.
Richard Schwartz
LinkedInExperience: Clinical Research Consultant Biotechnology and Pharmaceutical Development · Richard Schwartz, M.D.
Richard Schwartz began consulting in clinical research for the pharmaceutical and biotechnology industry in 1993 and works as a Clinical Research Consultant in biotechnology and pharmaceutical development, with a hematology and oncology focus. Richard was Vice President, Clinical Research at Axion Pharmaceuticals, Inc. (1993) and Director of Clinical Research - Biologicals at Bayer AG, Miles Inc., Cutter Biological Group (1981-1992).
Is this you? Claim your profile and get paid for calls.
Tania Johnstone Issa
LinkedInExperience: Independent Consultant in Clinical Trials Operations, Technologies, & Compliance · Seattle WA, Self Employed
Tania Johnstone Issa, based in Issaquah, Washington, has been an Independent Consultant in Clinical Trials Operations, Technologies, & Compliance since 2008 and a Consultant at Insite QA (formerly cGXP Consultants) since 2008 as well. Tania describes work across global clinical research operations and GCP compliance on Phase I-IV trials involving medical devices, biologics and pharmaceuticals, and was Global Director of Operations at OSI Systems (2005-2008).
Is this you? Claim your profile and get paid for calls.
Choose the right perspective
For oncology and rare disease, Andrew McGinn, Richard Schwartz and Marianne Sierra name those areas, and Kevin Corkery describes managing three pulmonary programs to FDA approvals. CRO and sponsor-side project management fit Annemarie Kleefstra and Katherine Bell, GCP compliance and inspection readiness fit Tania Johnstone Issa, late-stage clinical development fits Debra Lounsbury, and Jennifer Cockerham and Béatrice Selin bring long consulting practices in the U.S. and the Nordics.
Questions to take into the conversation
- 01For a first clinical trial, which tasks should a small sponsor keep in-house and which should go to a CRO or an independent consultant?
- 02What should a sponsor check in a CRO's study start-up plan before signing, especially on site selection and enrollment targets?
- 03Which documents and trial master file gaps most often cause trouble in a GCP inspection, and how early should a sponsor fix them?
About this directory
This is a professional research starting point based on business profile data retrieved on . Titles and companies reflect that source snapshot; roles marked former had ended by then. Check the linked profiles for current details. Inclusion does not imply Instant Expert membership or availability.