Sheryl L. Berkowitz
New York
Summary
Dynamic leader in Clinical Operations with over 12 years of experience in managing clinical trials for Medical Devices, Pharmaceuticals, and Dietary Supplements, driving accelerated time-to-market for sponsors. Established track record in securing more than five FDA approvals/clearances within the Ophthalmology sector by leveraging expertise in clinical project management principles. Skilled in leading high-performing teams of Project Managers with an emphasis on KPI-driven performance, mentorship, and fostering a culture of operational excellence. Strong analytical and troubleshooting skills enhance a solid background in financial oversight, resource forecasting, and profitability management for multi-million dollar projects, while consistently focusing on process improvement.
Qualified Director, Clinical Operations with proven background in strategic planning and project management. Successfully led cross-functional teams to deliver high-impact initiatives. Demonstrated excellence in stakeholder communication and operational efficiency.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Associate Director, Clinical Operations
Ora Inc.
01.2024 - Current
- Responsible for the oversight and growth of the entire clinical trial portfolio for the medical device department
- Support with all medical device client presentations development, proposal development, and serve as primary subject matter expert for project management on client bid-defense meetings
- Manage and lead a team of five (5) Project Managers providing supervision, mentoring and career development and KPI monitoring
- Provide project oversight ensuring adherence to deliverables, scope of work, and timeline management for medical device trials that has resulted in five FDA clearances (2 in 2024; 3 in 2025)
- Serve as the point of escalation for clients and cross-functional teams (Biostatistics, Data Management, Regulatory Affairs, etc.) and help to develop strategic contingency plans to mitigate clinical and operational risks
- Accountable for departmental financial health, oversight and goals that support with the company years success
- Spearhead several companywide initiative to standardization process, enhance client trust and ensure adherence to ICH-GCP E6 (R3) guideline changes
- Collaborate with cross-functional departments to provide executive level management with portfolio update, resource forecasting, and ......
- Supported with the deployment of the Veeva Risk-Based Study Management (RBSM) system, enhancing sponsor oversight capabilities and data-driven risk mitigation.
- Ensure compliance with regulatory, ICH-GCP and SOP guidelines
Senior Clinical Project Manager
Ora Inc.
08.2023 - 01.2024
- Responsible for line management to department Assistant Project Managers, Clinical Project Managers, and other supporting staff.
- Provides oversight to clinical trials for Assistant Project Managers and Clinical Project Managers.
- Manages cross functional project teams to deliver a high-quality clinical trial(s) in compliance with all regulations and SOPs.
- Collaborates with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects.
- Reviews protocol, source documents and CRFs and tracks them to completion.
- Responsible for creating and maintaining project timelines.
- Responsible for creating Project Plans (Roles and Responsibility Tables and Communication Plans) and weekly project budget and progress reviews for each study.
- Reviews study metrics for performance and quality with the team and management.
- Responsible for preparing high-quality reports (financial, project, etc.) for management on program status and issues.
- Ensures review of clinical electronic Trial Master File (eTMF) for completeness.
- Manages and coordinates all vendors involved in the clinical trials.
- Assists with department process improvement initiatives.
Clinical Project Manager
Ora Inc.
07.2021 - 08.2023
- Successfully ran and oversaw a phase three Ophthalmology Program with a combined budget of 50+ million consisting of two efficacy studies (25 sites each) plus long-term staff study (10 sites) lead to FDA approval in 2025.
- Responsible for operational and financial clinical study strategy development and execution from start-up to close-out.
- Manages cross functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s) in compliance with all regulations and SOPs.
- Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects.
- Collaborates cross-functionally with different groups to drive and complete clinical programs.
- Responsible for reviewing protocol, source documents and CRFs and tracks them to completion.
- Accountable for creating and maintaining project timelines for each project and uses these timelines to track and manage a project's progress.
- Responsible for creating Project Plans (Roles and Responsibility Tables and Communication Plans) and weekly project budget and progress reviews for each study.
- Reviews study metrics for performance and quality with the team and management.
- Prepares high-quality reports (financial, project, etc.) for management on program status and issues.
- Ensures review of clinical electronic Trial Master File (eTMF) for completeness.
- Manages and coordinates all vendors involved in the clinical trials (e.g. central labs, IVRS, reading centers).
Clinical Research Manager
Nutrafol
01.2020 - 07.2021
- Lead the conduct of clinical trials from start-up to close out; currently have successfully completed two clinical studies and two post-market clinical studies in the United States.
- Coordinate with Head of Clinical affairs on manuscript development; completed three publication submissions.
Clinical Project Manager/National Training Manager
RegenLab USA LLC
09.2018 - 12.2019
- Successfully managed the implementation of three clinical trials in North America: including a pivotal PMA study.
- Accountable for oversight management of approximately 20 sites.
- Collaborated with R & D, Regulatory Affairs, Legal and Quality Assurance regulatory on the development of clinical trial documentation to ensure the executions of timelines were met to launch investigational sites and patient enrollment deadlines.
- Developed and maintained the company training material and provided all new employees and customers with in-depth product training, including all applicable FDA guidelines.
- Responsible for supervision of all vendor management relationships involved in the clinical trial.
- Performed root cause analysis to identify and prevent repetitive clinical study deviations and site non-compliance.
- Evaluated site feasibility and strategically planned additional sites to meet enrollment subject criteria.
- Supported Director, Clinical Programs with contract and budget management.
- Contributed to overall effectiveness and development of the companies training and clinical study expansion.
Clinical Trial Coordinator/Clinical Science Liaison
RegenLab USA LLC
07.2014 - 09.2018
- Provided cross-functional oversight in all aspects of clinical trial management and execution, including protocol and case report form review, Institutional Review Board submission and documentation management.
- Assisted with the development of clinical study documentation creation and implementation.
- Responsible for study-start-up activities including evaluating site feasibility, site selection and negotiation of budget.
- Supported the North America quality assurance and quality control divisions, processing and recording product incidences.
- Facilitated all education to new regional sales managers, third-party independent sales representatives, legal counsel and customers on the various product line and FDA guidelines.
- Provided expert scientific and clinical knowledge in regenerative medicine products, current and past clinical developments, and innovate new applications.
- Presented and demonstrated the scientific and clinical product portfolio at clinics, investigator sites and conferences (American Academy of Dermatology & American Academy of Orthopedic Surgeons).
Business Development Executive
GBI Research
06.2013 - 07.2014
- Successfully on-boarded medical devices and pharmaceutical companies as new clients.
- Established and maintained excellent customer service by ensuring continuous follow-up and support.
- Provided companies with market research on a range of topics such as competitors and market data, valuations, clinical and market trends, product pipelines and forecast, which resulted in the companies unparalleled advantage over its competitors.
- Collaborated with executive team to implement business intelligence strategies required to solve critical time sensitive matters.
Patient Care Technician
Albany Medical Center
01.2013 - 06.2013
- Provided high-quality nursing assistance and patient care in a Cardiology unit serving twenty-seven patients.
- Responsible for coordination of patient care and phlebotomy.
- Facilitated patient care services between physicians, nurses, technicians, and other healthcare professionals in a fast paced and demanding environment, ensuring all parties were well informed of patient status and other vital information.
Education
Masters in Clinical Research Management and Organization -
Drexel University
12.2019
Bachelor of Science - Biology
University at Albany
05.2013
Skills
- Project management
- Strategic leadership
- Analytical thinking
- Coaching and mentoring
- Operations management
- Budget management
- MS office
- Product management
- Hiring and training
- Contract management
- Staff development
- Risk analysis
Affiliations
- Professional Associations
- Association of Clinical Research Professionals (ACRP) – 2016 to Present
- Society of Clinical Research Associates (SOCRA) – 2016 to Present
Certification
- Clinical Project Management Certificate
- Certified Clinical Research Associate (CCRA)
- Knowledgeable of ICH-GCP and FDA regulations
- Proficient in Microsoft Office Suite; Data Management System; and social media platforms
OTHER RELEVANT EXPERIENCE AND QUALIFICATIONS
- Abstract and Oral Presentations
- Berkowitz S., Marshall T., Raymond I., Kogan S., Evaluating the Efficacy of a Standardized Nutraceutical to Improve Hair Growth and Quality in Menopause Women: A Nine Month Subjective Single-Blinded Prospective Study. American Society for Dermatologic Surgery (ASDS) Annual Meeting, 2020.
- Marshall T., Berkowitz S., Raymond I., Kogan S., Evaluation of standardized nutraceuticals to improve hair growth in men and women of various ethnicities: A six month subjective single blinded prospective study. American Society for Dermatologic Surgery (ASDS) Annual Meeting, 2020.
Timeline
Associate Director, Clinical Operations
Ora Inc.
01.2024 - Current
Senior Clinical Project Manager
Ora Inc.
08.2023 - 01.2024
Clinical Project Manager
Ora Inc.
07.2021 - 08.2023
Clinical Research Manager
Nutrafol
01.2020 - 07.2021
Clinical Project Manager/National Training Manager
RegenLab USA LLC
09.2018 - 12.2019
Clinical Trial Coordinator/Clinical Science Liaison
RegenLab USA LLC
07.2014 - 09.2018
Business Development Executive
GBI Research
06.2013 - 07.2014
Patient Care Technician
Albany Medical Center
01.2013 - 06.2013
Bachelor of Science - Biology
University at Albany
Masters in Clinical Research Management and Organization -
Drexel University