I’m seeking a management-level role in Clinical Research or Clinical Operations, leading clinical studies, teams, and processes while partnering with clients and cross-functional stakeholders. Open to pharma, biotech, medical devices, aesthetics, and other life sciences fields, with leadership, responsibility, and strategic involvement.
Open to opportunities
Michal Shenhaut
@michalshenhaut
I build compliant clinical trial databases and lead clinical data review, coding, and quality activities.
IsraelWhat I'm looking for
At Bioforum the Data Masters, I manage clinical trial database development and amendments while ensuring alignment with Quality by Design principles, client guidelines, SOPs, and regulatory requirements.
I translate protocol requirements into eCRFs, data validation checks, and clinical quality checks. I lead clinical data review and serve as the focal point for clinical questions across Data Management teams.
I also lead MedDRA and WHODrug coding activities, from coding conventions and dictionary updates through quality control, status reporting, sponsor discussions, and database-lock readiness. I mentor configuration specialists and perform gap analyses for external and rescue studies.
Earlier, I worked as a Medical Coder, Validator, Project Manager, and Study Coordinator in neurology and neuroimmunology settings. I bring a Doctor of Veterinary Medicine degree, GCP training, and experience across Phase I–IV trials.
Experience
Work history, roles, and key accomplishments
BM
Current
Senior Configuration Specialist & Clinical Medical Advisor
Bioforum the Data Masters
Sep 2023 - Present (3 years)
Manages clinical trials database development and amendments in compliance with Quality by Design principles and regulatory guidelines. Leads clinical aspects of data management, including coding activities for MedDRA and WHODrug.
BM
Clinical Medical Advisor and Clinical Data Configuration Specialist
Bioforum the Data Masters
Apr 2022 - Aug 2023 (1 year 4 months)
Led clinical aspects of data management and configuration of clinical trial databases. Provided clinical input for eCRF design and quality checks, and managed coding activities for MedDRA and WHODrug.
BM
Clinical Medical Advisor
Bioforum the Data Masters
Apr 2019 - Mar 2022 (2 years 11 months)
Led clinical aspects of data management, including protocol review, eCRF design, and clinical quality checks. Managed coding activities for MedDRA and WHODrug, ensuring accuracy and consistency.
BM
Medical Coder
Bioforum the Data Masters
Dec 2018 - Mar 2019 (3 months)
Performed medical coding of clinical data using MedDRA and WHODrug, ensuring accuracy and consistency. Implemented coding conventions and managed dictionary updates.
BM
Validator
Bioforum the Data Masters
Dec 2018 - Mar 2019 (3 months)
Executed EDC validation testing activities to ensure database accuracy and compliance with study protocols. Created and executed manual test scripts and served as validation expert.
NC
Project Manager
Neurology Institute, Sourasky Medical Center
May 2018 - Nov 2018 (6 months)
Coordinated academic activities and liaised between developers and the Neurology Institute on feature requests. Monitored project resource needs and ensured continuity.
NM
Study Coordinator
Neuroimmunology Clinic, Neurology Institute, Sourasky Medica
Jan 2016 - Dec 2016 (11 months)
Ensured compliance with protocol and GCP guidelines, organized patient visits, and submitted SAEs and protocol deviations. Managed budget and contracts.
Education
Degrees, certifications, and relevant coursework
NN
NIDA Clinical Trials Network
Good Clinical Practice (GCP), Good Clinical Practice
Completed Good Clinical Practice (GCP) training from NIDA Clinical Trials Network in 2022 and 2025.
BC
Bio Medical College
CRA, Clinical Research
Completed the CRA certification from Bio Medical College in 2016.
SB
School of Agriculture and Veterinary Medicine, Bologna
Doctor of Veterinarian Medicine, Veterinary Medicine
Earned a Doctor of Veterinarian Medicine degree from the School of Agriculture and Veterinary Medicine, Bologna in 2015.
Tech stack
Software and tools used professionally
Availability
Open to opportunities
Location
IsraelAuthorized to work in
Salary expectations
106k-126k USD
Social media
Job categories
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