Maureen Shetty Email and Phone Number
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I'm an Associate Director, Global Clinical Trials, with expertise in innovating strategies to optimize patient enrollment and engagement in pharmaceutical development studies.What I do is lead clinical trial phases from operational planning and study initiation to completion of study enrollment, with an emphasis on oncology studies.The added value I bring to the table is that I am an expert in leveraging data-driven approaches to drive operational feasibility, recruitment, and retention strategies. Additionally, I support study teams, offering training and best practices with a deep understanding of regulatory requirements and industry standards.»»» EXPERTISE »»»☑ Clinical Trial Project Management☑ SOP Development☑ Study Initiation & Enrollment☑ Scenario Development☑ Site Selection☑ Diversity, Equity, & Inclusion☑ Global Strategic Feasibility☑ Patient Recruitment & Engagement☑ CRO/Vendor Management☑ Inspection Readiness☑ Risk Management☑ Clinical Trial Optimization☑ Continuous Improvement☑ Regulatory Requirements☑ R&D | ICH Guidance Documents☑ Clinical Study Operational Planning☑ Good Clinical Practice (GCP)☑ Training & Development
Genmab
View- Website:
- genmab.com
- Employees:
- 799
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Senior Manager, Clinical Trial PlanningGenmab Feb 2024 - PresentPlainsboro, Nj
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Associate Director, Trial Optimization LeadPfizer Jul 2021 - Jun 2023United StatesForecasted environmental projections for global studies in support of GSSO/CD&O clinical programs. Optimized enrollment scenarios for speed, country footprint, and center quantity to meet study objectives. Established systems and implemented processes to support early feasibility. Defined range of enrollment rates utilized in scenario development and benchmarking. Conferred with feasibility leads, clinical teams, and physicians in the evaluation of historical data to assess past performance. Mapped out best-case, worst-case, and mid-point implantation plans with dates and costs. Ensured consistent utilization of DVSO for enrollment planning and reporting using biostatistics for site selection. Evaluated and mitigated risks through data quality generation enrollment scenarios.► Earned performance award for mapping 30 scenarios in 72 hours; led user acceptance testing and recommended new processes to facilitate and accelerate clinical trials.► Leveraged DVSO operational expertise to coach and mentor cross-functional study management teams, SMT (feasibility leads, global teams, GSSO, CD&O, and CRO stakeholders).► Instituted new hire training program in 90 days; devised training on analytics projection algorithms and database structures. -
Senior Manager/Associate Director Clinical Project ManagementGsk Nov 2019 - Jul 2021Collegeville, PaSupported global clinical trial teams in developing study activity plans delineating site feasibility and patient recruitment initiatives while providing competitive analytics for proposed studies. Analyzed clinical trial enrollment data to ensure effective patient recruitment and feasibility team planning. Facilitated risk management discussions for all clinical research studies as subject matter expert on clinical trial drivers, project management, and Study Optimizer. Trained and mentored new team members. Acquired series of performance awards.► Raised team capacity, leading to numerous awards for handling substantial boost in workload under short time constraints. Initially faced with influx of 25 new projects, on top of existing 10-15; devised individualized project plans and seamlessly embrace additional workload.► Directed initial transition of projects from GSK to Tata Consulting in India and led remote training on processes, procedures, and risk management. -
Senior Manager Training And DevelopmentIcon Plc 2018 - 2019Blue Bell, PennsylvaniaConceived and executed MS Project training program and resources designed to benefit PRA and Bayer data management teams. -
Global Trial Optimization Manager, Oncology Women’S HealthIcon Plc 2017 - 2018Blue Bell, Pennsylvania, United StatesOffered recommendations and devised patient engagement, recruitment, and retention strategies to facilitate timely execution of clinical studies for oncology trial teams.
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Operations Recruitment ManagerIcon Plc 2012 - 2017Blue Bell, Pennsylvania, United StatesDeveloped study materials, collaborated with vendors, and handled clinical trial projects for all therapeutic areas and phases, ensuring compliance with local and global regulations. Worked alongside IT vendor to produce digital content.► Cut patient recruitment website costs in half, negotiating master service agreements with top 3 vendors providing mobile apps for clinical trials; consolidated from 10 vendors to 3.► Lowered time to write ICFs 50% after designing templates; authored informed consent forms (ICFs), standard operating procedures (SOPs), and patient recruitment and retention materials to enroll patients in clinical trials.m Innovated creative marketing and recruiting strategies for pediatric study on IBS; collaborated with vendor to developengaging superhero-themed comic books for children to easily understand.
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Clinical Trial Technology ManagerIcon Plc 2011 - 2012Blue Bell, Pennsylvania, United StatesFacilitated clinical trial pilot programs and special projects within innovation team with focus on enhancing clinical trial processes. Composed technical user requirements for clinical trial tools consistent with client specifications. Established quality standards for digital technologies for clinical trials in collaboration with study team, IT, and vendors. Oversaw translation of Investigator Databank site brochure into 18 languages each with 2 versions.
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Senior Project ManagerIcon Plc 2010 - 2011Blue Bell, Pennsylvania, United StatesDesigned clinical trial websites tailored to healthcare professionals and managed approval process for patient recruitment websites. Created and updated user manuals and SOPs. Oversaw vendor management for website and mobile application designs. Performed monthly audits, collected site metrics reports for GTMs, and led annual corporate compliance audits.
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Senior Project Manager, Training & Patient RecruitmentEpharmasolutions Aug 2007 - Apr 2010Handled budget management, supervised client and site management, and ensured alignment with client expectations. Delivered presentations during investigator meetings, outlining training requirements for clinical trials and guiding attendees on accessing study website. Obtained PMI Certification, completing 40 hours of online training and testing. -
Associate Content SpecialistMerck Feb 2007 - Jul 2007► Responsible for editing and refining clinical trial scientific data and content to deliver clear, concise and professional quality e-learning modules, slide sets, posters and other meeting materials for clinical trials.► Created clear, concise, accurate and professional quality e-learning modules for Merck Research Lab (MRL) from scientific content and clinical trial study results. -
Training CoordinatorWyeth Jun 2001 - Dec 2006Collegeville, PaWon highest award in group for conceptualizing industry innovation (digital wallet card). Developed and delivered comprehensive training and communication materials to facilitate the seamless integration of proprietary learning management system (LMS). Enabled maintenance of employee training records and streamlined report generation for EMEA, FDA, and internal audits and inspections. Slashed training costs after implementing e-learning module globally to 5,000 employees. Ensured continuous accessibility of training resources and provided real-time tracking of crucial training records.
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Training SpecialistWyeth Pharmaceuticals Apr 2001 - Jun 2003Radnor, PaResponsible for entire safety department's training documentation and tracking.Took an entire safety department over 300 employees from a paper based training and compliance system to a paperless system allowing easy compliance review of training, SOP and resume completion for audits and inspections. Learning management system manager, reviewed, QA tested and trained department on new system and implemmented changes to the system as necessary.Prepared documentation for internal and external audits and inspections.Expect in Microsoft Office Suite.
Maureen Shetty Skills
Maureen Shetty Education Details
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3.6 Cum Laude
Frequently Asked Questions about Maureen Shetty
What company does Maureen Shetty work for?
Maureen Shetty works for Genmab
What is Maureen Shetty's role at the current company?
Maureen Shetty's current role is Associate Director, Global Clinical Trials Specializing In ► Clinical Trial Project Management | SOP Development | Study Initiation & Enrollment | Scenario Development.
What is Maureen Shetty's email address?
Maureen Shetty's email address is ma****@****zer.com
What is Maureen Shetty's direct phone number?
Maureen Shetty's direct phone number is 148494*****
What schools did Maureen Shetty attend?
Maureen Shetty attended Fox School Of Business At Temple University, University Of Phoenix, Cabrini University.
What skills is Maureen Shetty known for?
Maureen Shetty has skills like Pharmaceutical Industry, Clinical Trials, Ctms, Gcp, Clinical Development, Sop, Fda, Cro, Clinical Research, Quality Assurance, Clinical Data Management, 21 Cfr Part 11.
Who are Maureen Shetty's colleagues?
Maureen Shetty's colleagues are Ryan Behrend, Athanasios Blanas, Phd, César Oliveira Costa, Frank Oriold, Siri Eranki-Aditha, Brooke Digiuseppe, Cmp, Patrick Franken.
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