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ROCHELLE Greenbaum

@rochellegreenbaum

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Experienced clinical operations director with a focus on strategic management.

United States

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What I'm looking for

I am seeking a role that offers leadership opportunities and the chance to drive impactful clinical research initiatives.

I am a seasoned professional with over 25 years of experience in Clinical Research, specializing in Clinical Operations. My career has been marked by my ability to develop and manage comprehensive clinical programs, overseeing multiple studies from initiation to closeout. I have a proven track record of leading cross-functional teams and ensuring inspection readiness, serving as a Subject Matter Expert during FDA and EMA inspections.

Throughout my tenure at PTC Therapeutics, I have successfully managed Phase I, II, and III studies in various therapeutic areas, including Phenylketonuria and ALS. My leadership has driven strategic goals, improved processes, and ensured compliance with Good Clinical Practices. I am passionate about mentoring my team and fostering an environment of growth and excellence in clinical operations.

Experience

Work history, roles, and key accomplishments

Current

Director, Clinical Operations

Current

PTC Therapeutics, Inc.

Jul 2018 - Present (7 years)

Oversaw Phase I, Phase II, and Phase III studies in various therapeutic areas, ensuring alignment with strategic goals. Served as a Subject Matter Expert for FDA and EMA inspections, managing clinical program budgets and identifying process improvements.

Clinical Operations Program Management FDA Inspections EMA Inspections Budget Management Process Improvement Risk Management

Senior Manager, Clinical Operations

Eisai Inc.

Jul 2007 - Jul 2018 (11 years)

Led global Phase I, Phase II, and Phase III CNS studies, overseeing CROs and managing study budgets. Directed site startups, ensuring timely regulatory submissions and efficient supply chain management.

Clinical Operations CRO Budget Management Regulatory Submissions Patient Recruitment Monitoring Report Review Training Mentoring

Clinical Scientist II

Forest Laboratories, Inc.

Jul 2005 - Jul 2007 (2 years)

Served as Lead Clinical Scientist for a Phase III fibromyalgia study, ensuring compliance with FDA regulations and ICH guidelines. Managed a Clinical Trial Assistant and coordinated the review and approval of study documents.

FDA Regulation ICH Guidelines SOPs Document Management Training

Clinical Research Associate II

Berlex Laboratories, Inc.

Sep 2003 - Jul 2005 (1 year 10 months)

Responsible for the selection, initiation, monitoring, and close-out of clinical sites for Phase I-III trials in cardiovascular and pediatric gastroenterology. Participated in protocol review and CRF development, and mentored junior CRAs.

Clinical Research Site management Clinical Trial Protocol Review CRF Development Training Mentoring Clinical Trials

Clinical Research Associate/Medical Writer

Synergy Research, Inc.

Apr 2000 - Sep 2003 (3 years 5 months)

Managed clinical trials for a CRO in therapeutic areas including diabetic neuropathy and infectious disease. Performed initiation, interim monitoring, and close-out visits, and authored various study-related documents.

Clinical Trial Management CRO Monitoring Visits Medical Writing SOPs

Education

Degrees, certifications, and relevant coursework

Hunter College

Master of Science, Environmental and Occupational Health Sciences

Completed a Master of Science degree focusing on Environmental and Occupational Health Sciences. Gained in-depth knowledge of health and safety principles relevant to various work environments.