Michelle Malanga
New York
Summary
Directed clinical research management initiatives with certifications in clinical research (CCRP) and healthcare compliance (CHRC). Oversaw site management and development of research contracts and budgets within healthcare environments. Navigated CMS and FDA regulations to ensure compliance. Led in-house monitoring of clinical research studies, including U.S. and international consortium projects. Managed staff training, protocol preparation, grant writing, and compliance oversight for programs in diverse communities. Cultivated excellent communication and critical thinking skills. Adapted strategies to meet evolving challenges. Specialized in clinical research budgeting and contracts, with a strong understanding of FDA regulations and good clinical practices across multiple specialties.
Overview
31
31
years of professional experience
Work History
Clinical Research Manager - Department of Clinical Research and Education
Physicians Regional Medical Center
02.2005
- Develop protocols, monitor coordinators CRF completion and clinical trial oversight.
- Negotiates contract and sets budget.
- Work with physicians directly on development of study protocols.
- Regulatory management of protocols including IRB submissions.
- (Medical Surgical Specialists formerly Cleveland Clinic Florida)
Local Trial Manager
ICON
05.2022 - Current
- Services rendered will adhere to applicable Johnson & Johnson SOPs, WI, policies, local regulatory requirements, etc.
- Complies with relevant training requirements.
- Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of pre-trial assessment visits and appropriate follow-up of pre-trial visit report and country feasibility report. Collaborates with central study team for final selection of sites to participate in trial.
- Ensures local/country team is meeting requirement targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Act as a primary company contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed.
- May schedule and conduct a local/county investigator meeting.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. When necessary initiates corrective and preventative actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
- Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study supply.
Project Management
Coalition of Cancer Cooperative Groups
01.2022 - 05.2022
- Responsible for managing research activities for federally funded protocols and member sites
- Protocol training and database build outs for clinical trials.
- Responsible for monitoring of and reporting of data and safety reporting.
- Interaction with Physicians and Director for coalition and sponsor directed studies
Contracted Director of Research
Sadick Research Group
06.2021 - 11.2021
- Responsible for successfully managing research activities
- Manages research protocols in coordination with faculty and staff.
- Protocol development to ensure compliance and adherence to GCP regulations.
- Facilitates interactions and collaborations with faculty and pharmaceutical and device companies.
- Budget analysis and research billing.
- Manages invoicing and reconciliation of billing across multiple vendors.
Clinical Ops Project Manager
Multiple Myeloma Research Consortium
08.2019 - 05.2021
- Responsible for managing research activities for member sites in the Multiple Myeloma Research Consortium.
- Create budgets in alignment with the Centers for Medicare & Medicaid (CMS)
- Manages Central IRB submissions for research protocols in oncology.
- Contractual oversight for over 10 medical institutions for Consortium.
- Manages invoicing and reconciliation of billing across multiple vendors.
- Protocol training and database build outs for clinical trials.
- Responsible for FDA IND and IDE submissions and annual reporting of high-level data and safety reporting.
Global T-cell Lymphoma Consortium Administrator Compliance & Regulatory Management
Columbia University Medical Center
09.2017 - 08.2019
- Start-up National & International consortium sites
- Manage budgets & contracts with consortium partners
Centers for Lymphoid Malignancies Compliance & Regulatory Management
09.2014 - 09.2017
- Responsible for clinical research protocols oversight and submissions to Institutional review Board (IRB), Data Safety Board (DSMB) and Food and Drug Administration (FDA).
- Oversees and manages budgets for clinical trials.
- Management of research protocols in coordination with faculty and staff.
- Facilitates the department’s interactions and collaborations with other departments, outside institutions, and government agencies.
- Responsible for research compliance and monitoring for institutional and site agencies.
- Compliance monitors across institutional departments to ensure adherence to federal and institutional guidelines.
Director, Clinical Research Administration
NYU Cancer Institute Division Radiation Oncology
06.2011 - 10.2013
- Responsible for successfully managing research activities in the Department of Radiation Oncology including budgets and regulatory oversight.
- Manages research protocols in coordination with faculty and staff.
- Protocol development to ensure compliance and adherence to NCI regulations.
- Facilitates the department’s interactions and collaborations with other departments and programs at NYU, government agencies, the private sector, and industry and serves as an experienced expert for faculty regarding the research process.
Protocol Review and Monitoring Committee Administrator Mount Sinai School of Medicine Tisch Cancer Institute
Cancer Institute Clinical Administrative Manager
08.2010 - 06.2011
- Administrator for scientific review and oversight of all cancer related protocols.
- Functions as liaison between cancer institute and Mount Sinai School of Medicine faculty in protocol develop and submissions to PRMC review.
- Functions in developing CCSG grant and organizing protocol-monitoring system for National Cancer Institute (NCI) - designation.
- Oversight of compliance in cancer research protocols.
- In-depth knowledge of oncology regulations and science including RECIST criteria, and Cooperative Groups including RTOG.
Clinical Research Manager
02.2009 - 07.2010
- 2009 Recipient of Team Achievement Award.
- Management of budgets and contracts for industry oncology trials.
- Oversight of billing compliance in clinical trials.
- Medicare Coverage Analysis for both Industry and NIH- NCI clinical trial budgets.
- Creation of billing plans and oversight and negotiation of clinical trial budgets requiring in-depth knowledge of billing practices in both clinic and hospital setting CTMS and hospital billing services.
- New York University Langone Medical Center
Corporate Clinical Research Manager
Health Management Associates (HMA)
03.2007 - 02.2009
- 2008 Corporate Recognition of Achievement for Letter of Recognition and Corporate Stock Award
- Development of Clinical Research programs within hospital and clinics across national hospital system.
- Maintains corporate contracts and budgets for research divisions.
- Start-up and training of clinical research staff in clinical and hospitals.
- In-house Clinical Research associate to monitor study compliance across hospital system
- Function as compliance auditor for clinical research programs.
- Working knowledge of CMS rules and regulations.
- Establish educational meetings and seminars on corporate compliance, FDA regulations, and Good Clinical Practice (GCP) for clinical research.
- Work directly with HMA legal division and Compliance Officer on corporate compliance in hospital billing for clinical research trials.
Research Study Consultant - Pediatric GI & Nutrition
Baylor College of Medicine
09.2004 - 02.2005
- Recruit of patients on research protocols and study management.
- Analysis of intestinal functioning and interpretation.
- Manometric Techniques and Analysis.
- Knowledge of feeding strategies in the Newborn including breast-feeding protocol requiring in-depth knowledge of WIC programs.
- Utilizing phlebotomy and lab skills for ongoing study.
Clinical Research Study Coordinator/Manager
Baylor College of Medicine
01.1997 - 01.2004
- Children’s Nutrition Research Center.
University of Texas Medical Branch at Galveston
01.1995 - 01.1997
- Department of Pediatric Infectious Disease
Education
Master of Science - Bioethics
Columbia University School of Professional Studies
01.2020
Master of Public Administration - undefined
Baruch College School of Public Affairs
01.2013
Master’s Study - undefined
University of Texas School of Public Health
01.2009
Bachelor of Science - Biology, English
The City College of New York
01.1994
Police Officer
New York City Police Academy
01.1978
Skills
- Certified Clinical Research Professional-CCRP
- Certified in Healthcare Compliance- CHRC
- Trained in coordinating and designing clinical protocols
- In-depth knowledge of FDA regulations
- CRA protocol monitoring
- Excellent firsthand clinical ability and knowledge of disease processes
- Expertise in Oncology, RECIST, Data Safety & Monitoring; Pediatric Oncology; Neonatal; Phase I-IV Drug/Device Studies
- Database skills in CTMS-InfoEd, Study Manager, Google Docs, SharePoint, Velos and EPIC
- Strong Science background, skills, and knowledge for utilization in science and grant writing
Accomplishments
- Police Officer - retired N.Y.P.D. Honorable Discharge – Awarded Officer of the Month 7- time.
- Bronze Medal Recipient Police Olympics
Affiliations
- Police Benevolent Association present
- American Association for the Advancement of Science present
- SoCRA Society of Clinical Research Associates present
- Health Care Compliance Association (HCCA) present
Publications
- Oral 5-azacytidine and romidepsin exhibit marked activity in patients with PTCL: a multicenter phase 1 study. O'Connor, Owen A; Falchi, Lorenzo; Lue, Jennifer K; Marchi, Enrica; Kinahan, Cristina; Sawas, Ahmed; Deng, Changchun; Montanari, Francesca; Amengual, Jennifer E; Kim, Hye A; Rada, Aishling M; Khan, Karen; Jacob, Alice T; Malanga, Michelle; Francescone, Mark M; Nandakumar, Renu; Soderquist, Craig R; Park, David C; Bhagat, Govind; Cheng, Bin; Risueño, Alberto; Menezes, Daniel; Shustov, Andrei R; Sokol, Lubomir; Scotto, Luigi. Blood ; 134(17): 1395-1405, 2019 Oct 24.
- Henning, S., and Malanga Michelle. "La digestión y absorción directa de la lactosa en cuanto a absorción neta de agua, actividad lactasa-específica, y unidireccional flujo de agua-lumen a mucosa en lactantes prematuros, mediante el uso de la técnica de catéter de perfusión de triple Lumen." Texas, Houston 15.
Timeline
Local Trial Manager
ICON
05.2022 - Current
Project Management
Coalition of Cancer Cooperative Groups
01.2022 - 05.2022
Contracted Director of Research
Sadick Research Group
06.2021 - 11.2021
Clinical Ops Project Manager
Multiple Myeloma Research Consortium
08.2019 - 05.2021
Global T-cell Lymphoma Consortium Administrator Compliance & Regulatory Management
Columbia University Medical Center
09.2017 - 08.2019
Centers for Lymphoid Malignancies Compliance & Regulatory Management
09.2014 - 09.2017
Director, Clinical Research Administration
NYU Cancer Institute Division Radiation Oncology
06.2011 - 10.2013
Protocol Review and Monitoring Committee Administrator Mount Sinai School of Medicine Tisch Cancer Institute
Cancer Institute Clinical Administrative Manager
08.2010 - 06.2011
Clinical Research Manager
02.2009 - 07.2010
Corporate Clinical Research Manager
Health Management Associates (HMA)
03.2007 - 02.2009
Clinical Research Manager - Department of Clinical Research and Education
Physicians Regional Medical Center
02.2005
Research Study Consultant - Pediatric GI & Nutrition
Baylor College of Medicine
09.2004 - 02.2005
Clinical Research Study Coordinator/Manager
Baylor College of Medicine
01.1997 - 01.2004
University of Texas Medical Branch at Galveston
01.1995 - 01.1997
Master of Science - Bioethics
Columbia University School of Professional Studies
Master of Public Administration - undefined
Baruch College School of Public Affairs
Master’s Study - undefined
University of Texas School of Public Health
Bachelor of Science - Biology, English
The City College of New York
Police Officer
New York City Police Academy