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Experienced Director Data Management with a demonstrated history of working in the pharmaceuticals industry. Skilled in Medical Devices, Medidata, Clinical Data Management, Biotechnology, and Management. Strong research professional with a Juris Doctorate
Monte Rosa Therapeutics
View- Website:
- monterosatx.com
- Employees:
- 194
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Senior Director, Data ManagementMonte Rosa TherapeuticsCambridge, Ma, Us
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Senior Director Data ManagementModerna Jun 2023 - PresentCambridge, Massachusetts, Us -
Director Data ManagementModerna Nov 2018 - Aug 2023Cambridge, Massachusetts, Us
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Associate Director, Clinical Data ManagementTesaro, Inc. Jun 2013 - Nov 2018Waltham, Massachusetts, Us -
Contract Senior Clinical Data ManagerEdwards Lifesciences May 2012 - Jun 2013Irvine, Ca, Us• Lead database development activities of studies in Transcatheter Heart Valve (THV) program• Participates in new site initiation visits to train investigators and research coordinators • Develop Team Project Plans in Microsoft Project• Provide Case report form (eCRF) requirements including triggers and edit checks• Interfacing with the clinical project team as needed to refine clinical requirements• Review and clean data according to study documentation, clinical data management system, listings and reports• Track data flow, review status and provide updates to team• Perform site/user administration of EDC studies• Perform User Acceptance Testing of forms, requirements and edit checks• Participate in development and review of policies, SOPs, work instructions and associated documents for Clinical Data Management -
Senior Clinical Data ManagerAptiv Solutions Apr 2009 - Apr 2012Marlborough, Massachusetts, Us• Responsible for vendor management of multiple parties to ensure high quality data integrity• Managed, built, and validated clinical databases in an Oracle Clinical environment• Identified, developed and implemented project processes to improve/enhance time and cost efficiencies• Manually reviewed data to ensure integrity and conformance to standard operating procedures -
Contract Senior Data ManagerSunovion Pharmaceuticals Inc. 2006 - Feb 2009Marlborough, Ma, Us• Provided quality management and leadership of clinical trials, ensuring data integrity• Generated clinical trial data utilizing Electronic Data Capturing systems • Oversaw and delegated work to 4 clinical data analysts for study activities• Led three clinical research trials; collected data, reviewed for accuracy and provided clean data to statisticians• Performed thorough query review to eliminate errors/omissions• Tested and validated database designs• Defined the processes and created internal work instructions• Interacted with multiple clients in the field, including statisticians, clinical staff and Primary Investigators to ensure successful completion of clinical trials • Ensured study deliverables and timelines were met in collaboration with the sponsor’s budget and hourly requirements• Managed customer satisfaction by participating in conference calls and providing timely and accurate updates• Participated and presented data management responsibilities at Investigator Meetings• Trained study sites and Clinical Research Associates on study processes and data activities• Reviewed and participated in development on Project Management Plan -
Clinical Data ManagerPremier Research 2003 - 2004Morrisville, Nc, Us• Established first in-house data management department at leading pharmaceutical client • Provided on-site support to sponsor by developing internal guidelines for study, department SOPs and work guidelines• Set-up studies and identified responsibilities and assigned tasks to other data managers• Managed data validation, overseeing Oracle Clinical data management system -
Project CoordinatorEastern Cooperative Oncology Group 2000 - 2003• Supervised up to 10 employees delegating assignments, conducting progress and performance reviews, interviewing and recommending hires• Led a pivotal study on Breast Cancer Research • Registered over 5000 patients and managed quality control of data• Developed standards for clinical practice, storage, data integrity and how to handle samples• Presented to doctors, surgeons and sites on data management integrity and collection at nationwide group meetings
Michael Petrone Skills
Michael Petrone Education Details
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Massachusetts School Of LawLaw -
Stonehill CollegePsychology
Frequently Asked Questions about Michael Petrone
What company does Michael Petrone work for?
Michael Petrone works for Monte Rosa Therapeutics
What is Michael Petrone's role at the current company?
Michael Petrone's current role is Senior Director, Data Management.
What is Michael Petrone's email address?
Michael Petrone's email address is mi****@****rds.com
What is Michael Petrone's direct phone number?
Michael Petrone's direct phone number is +133997*****
What schools did Michael Petrone attend?
Michael Petrone attended Massachusetts School Of Law, Stonehill College.
What skills is Michael Petrone known for?
Michael Petrone has skills like Clinical Data Management, Edc, Clinical Trials, Data Management, Cro, Pharmaceutical Industry, Gcp, Sop, Ich Gcp, Biotechnology, Oracle Clinical, Software Documentation.
Who are Michael Petrone's colleagues?
Michael Petrone's colleagues are Michelle Matysik, Anthony Noyes, Beatrice Ranieri, David Lyon, Rémi Fertin, Gian Marco De Donatis, Rory Coffey, Phd.
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