Summary
Overview
Work History
Education
Skills
Affiliations
Publications
Timeline
Generic

Yvette Monroe-Hinds

Burlington,USA

Summary

Senior management professional, bringing strategic leadership and operational excellence to drive organizational success. Skilled in project management, team collaboration, and process optimization with keen focus on achieving results. Adept at navigating complex challenges, fostering culture of accountability, and adapting to evolving business needs. Known for strong decision-making, effective collaboration, and building high-performing teams.

Overview

24
24
years of professional experience

Work History

Senior Manager, Clinical Trial Associate Team - Global Clinical Operations

Takeda Pharmaceutical Company Limited
05.2022 - Current
  • Manage a team of Clinical Trial Associates (CTAs) at various levels of experience to deliver effective clinical trial support across a large portfolio of critical trials in the Rare Disease & Gastrointestinal Therapeutic Areas
  • Vital member & contributor in the GI² TAU ensuring successful pipeline delivery & appropriate resource allocation, with a primary focus on R&D KPIs
  • Collaborate with GP Clinical Operations Managers regularly to align on COM & CTA resources, receive insights on upcoming studies, discuss training and overall study support needs, mitigate issues, and align on growth & development opportunities (e.g. LCTA to COM pathway continuous implementation)
  • Leads and/or serves as subject matter expert in complex activities such as trial process development, complex therapeutic area and/or program support or department or business critical initiatives and deliverables (e.g. Future Fit Veeva Vault Clinical Inception Sprints & Change Champion, CDMS External User Request Workstream, Senpai Program & Lead CTA to COM Framework continuous implementation, CTA Performance Development Framework, and CTA Manager Ways of Working)
  • Participated in Takeda's ACHIEVE Cohort 6, 7-month Leadership Program exploring emerging technologies, initiatives, and best practices in sustainability outside organization to ensure Takeda's commitment to the planet
  • Support the R&D strategy to promote a positive, results-driven environment to foster internal growth, advancement, and movement within the Takeda organization
  • Promote a consistent and efficient approach to optimize successful cross-functional trial execution through familiarity with various systems (e.g. ELEVATE & COMPASS)
  • Provide oversight of the day-to-day activities of direct reports by providing training, guidance, and coaching, to achieve organizational goals and ensure timely management and resolution of identified issues
  • Motivates the CTA team to achieve organizational goals, delegating tasks and implementing timelines to achieve targets to ensure high quality service and outstanding stakeholder support
  • Provide ongoing feedback & recommendations during Quality Conversations and End-of-Year Feedback, leveraging the Lead CTA to COM Pathway to foster promotion of several Lead CTAs to COM roles
  • Provides feedback on an ongoing basis and formally during the annual performance evaluation process to support continued development & growth
  • Contribute to resource needs through appropriate hiring, performance management and succession planning
  • Contributes to the development of and leads assigned departmental objectives and business goals, representing CTA Management and Global Development Operations (GCO Playbook)

Diversity, Equity, Inclusion Clinical Trial Operations Lead

Janssen Pharmaceuticals
08.2021 - 05.2022
  • Developed and presented strategic DE&I recommendations for clinical trials in Cardiovascular, Metabolism, Renal, and Pulmonary Arterial therapeutic areas based on FDA guidance
  • Participate in study-related meetings including Kick-off Meetings, Study Management Team Meetings, Clinical Program and Clinical Functional Trial Team Meetings, and Investigator Meetings
  • Responsible for all aspects of recruitment/retention project management specifically related to diversity, equity, and inclusion including integration/coordination of vendor services
  • Develop, present and facilitate recruitment/retention training sessions, specifically related to diversity, equity and inclusion, including internal trainings, study team trainings and investigator meeting presentations/workshops
  • Create a diversity strategy for study team and study sites
  • Conduct ongoing assessment of the recruitment/retention strategy, specifically related to diversity, equity and inclusion to determine if scope of services is achieving study enrollment goals

Senior Manager, Clinical Operations Program Lead – Global Clinical Operations

Takeda Pharmaceutical Company Limited
09.2020 - 08.2021
  • Senior Manager, Clinical Operations Program Lead for VPRIV and Replagal Programs, Acting Senior Manager, COPL since May 2020
  • Develop and lead the operational strategy based on the Clinical Development Plan and planning for three rare diseases programs VPRIV for the treatment of Gaucher Disease, Replagal for the treatment of Fabry Disease, and Elaprase for the treatment of Hunter Syndrome (MPSIII) in close collaboration with internal and external partners
  • Provide program-level sponsor operational oversight of strategic partners for new and ongoing Gaucher Disease and Fabry Disease studies to ensure the effective execution of the clinical studies with the highest quality, execution per timeline and agreed budget.
  • Provide program-level operational oversight and work closely with Takeda Clinical Quality Assurance and functional leads to address ongoing CAPA activities with Home Health Care and Imaging Vendors
  • Represent Clinical Operations at the Global Program Team (GPT) by presenting achievements and escalate challenges for clinical studies and the programs
  • Lead the Clinical Sub-team (CST) through a strong partnership with the Global Functional Area Leads to ensure the development and execution of the Clinical Development Plan
  • Serve as the Primary Point of Contact with Takeda Development Center (TDC) Asia (China Team) to ensure on time regulatory submission, study team engagement, and study execution of VPRIV and Replagal Post Approval Commitment (PAC) studies
  • Serve as the primary lead and contact overseeing Senior COMs contractors who manage Gaucher Disease and Fabry Disease studies
  • Manage the financial aspects during the on-hold period of an Open-label Phase III Safety and Efficacy study and the extension Long-term Safety and Efficacy study in Japanese subjects with Chronic Hypoparathyroidism
  • Serve as primary point of contact with Takeda Development Center (TDC) Japan Director for Marketed Products studies operationalized in Japan
  • Contribute to functional initiatives and process improvement within GCO
  • Participate in the interview, hiring, and onboarding process for new hires and mentoring of new hires and Clinical Operations Managers

Senior Clinical Operations Manager – Global Clinical Operations

Takeda Pharmaceutical Company Limited
11.2019 - 09.2020
  • Acting Senior Manager, Clinical Operations Program Lead for the VPRIV (Gaucher Disease) and Replagal (Fabry Disease) Programs (May 2020)
  • Develop and lead the operational strategy and planning on the VPRIV and Replagal programs in close collaboration with internal and external partners
  • Provide program-level sponsor operational oversight of strategic partners for new and ongoing VPRIV and Replagal studies to ensure the effective execution of the clinical studies with the highest quality, execution per timeline and agreed budget.
  • Represent Clinical Operations at the Global Program Team (GPT) and develop a strong partnership with the Global Clinical Leads to lead the Clinical Sub Team (CST) to ensure the development and execution of the Clinical Development Plan
  • Serve as the primary contact overseeing Senior COM contractors who manage Gaucher Disease and Fabry Disease studies
  • NATPARA Phase 4 trial closeout for rhPTH (1-84) in Hypoparathyroidism after FDA recall over rubber particulates potential to contaminate the medication
  • Collaborated with Patient Post-Trial Access Team to ensure availability of NATPARA to patients upon completion of the clinical trial
  • Manage the planning, implementation, and execution of an Open-label Phase III Safety and Efficacy study and the extension Long-term Safety and Efficacy study in Japanese subjects with Chronic Hypoparathyroidism
  • Serve as Primary Point of Contact with Takeda Development Center (TDC) Japan Director for Marketed Products studies managed from Japan
  • Contribute to functional initiatives and process improvement within GCO
  • Participate in the interview and onboarding process for new hires and mentoring of new hirers and Clinical Operations Managers

Senior Clinical Project Manager – Global Clinical Development Operations

Shire, a Wholly Owned Subsidiary of Takeda Pharmaceutical Company Limited
04.2018 - 11.2019
  • Manage the planning, implementation, and execution of a rare disease Open-label Phase III Safety and Efficacy study and the extension Long-term Safety and Efficacy study in Japanese subjects with Chronic Hypoparathyroidism
  • Manage clinical outsourcing and budget planning of full service CRO (IQVIA, Japan K.K. and PPD), central laboratory (Q² Solutions & PPD central laboratory), IRT vendor (EndPoint Clinical), Antibodies testing (Covance); Subject travel arrangements (Colpitts World Travel), Payment to sites for subject visits (DrugDev) and Drug courier service (Marken)
  • Conducted sponsor oversight by utilizing and periodically updating the Oversight Needs Assessment and Compliance Risk Assessment tools to provide support and guidance to strategic partners/CRO to ensure study issues are addressed and timely resolved
  • Lead and collaborate with the Regional Area Director in Japan in the oversight of site feasibility, identification, and selection
  • Collaborate with the Medical, Device, and Patient Recruitment and Engagement team members and selected vendors to develop robust IP Instructions for Use and training materials for the Investigation Sites and patient/caregivers to foster IP assembly, preparation, and administration adherence. Training materials including Site and Patient Training Guides, practice kits for hands-on practice, IP instruction video were utilized and well received at the Investigator's Meeting.
  • Author study related documents including but not limited to the Informed Consent, Subject Investigational Product and Supplement Diaries, Pharmacy Manual, Study Management Plan, IP preparation and administration compliance checklist, and Investigator Meeting presentations
  • Review and approve various study related documents and plans, including but not limited to vendor proposals, budgets and invoices, Communication Plan, Project Management Plan, Data Review Plan, and Statistical Analysis Plan
  • Develop and update study timelines and collaborate with functional area leads to achieve study deliverables by the agreed upon timelines
  • Develop, deliver, and when requested present monthly slides related to study status, timelines, and current and projected enrollment
  • Serve as Primary Point of Contact with Takeda Development Center (TDC) Japan Director for Marketed Products studies managed from Japan
  • Participate in the interview, mentoring, and onboarding process for new hires and junior Clinical Operations Managers

Clinical Project Manager – Global Clinical Development Operations

Shire, a Wholly Owned Subsidiary of Takeda Pharmaceutical Company Limited
09.2016 - 04.2018
  • Manage the planning, implementation, and execution of a rare disease, Phase III Safety, Efficacy, Pharmacodynamic, and Pharmacokinetic Study in Japanese Pediatric Subjects with Short Bowel Syndrome Dependent on Parenteral Support
  • Manage the planning, implementation, and execution of the Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Japanese Pediatric Subjects with Short Bowel Syndrome Who Completed SHP633-302
  • Manage clinical outsourcing of full service CRO (Quintiles Transnational Japan K.K.), central laboratory (Q² Solutions), Data Safety Monitoring Committee (DSMC) (Watermark Research Partners, Inc.)
  • Author study related documents including but not limited to the Parent/Guardian and Assent Forms, DMC Charter, Study Management Plan, Patient Diaries, Pharmacy Manual
  • Review and approve various study related documents and plans, including vendor proposals and budgets, Communication Plan, and Project Management Plan
  • Develop the study timelines and lead the study team to deliver the clinical study by the agreed upon timelines
  • Successful collaboration with Medical Monitor, Patient Recruitment and Engagement Lead, and vendor to develop Site and Patient Training Materials to enhance understanding and usage of device assembly, administration, and storage. Training materials were presented at the Investigator Meeting through video in Japanese and an interactive hands-on session allowed Principal Investigators and CRO personnel the opportunity to practice assembling the device, practice mock administration and ask questions.
  • Lead and collaborate with the RADs in Japan in the oversight of site feasibility, identification, and selection
  • Review site feasibility contract reports generated by the RADs and clinical supply lead
  • Collaborates with clinical supply lead to ensure on-time delivery of clinical trial supplies
  • Provide periodic status reports regarding study timelines, site feasibility, enrollment, budget, etc
  • Develop and monitor the clinical study budget and review and approve vendor invoices

Senior Clinical Trial Associate – Clinical Development Operations

Shire, a Wholly Owned Subsidiary of Takeda Pharmaceutical Company Limited
09.2014 - 09.2016
  • Review and provide feedback on study related documents including but not limited to ICF, CRF specifications, TMF Roadmap, Communication Plan, Data Review Plan, Project Management Plan, Vendor Oversight Plan
  • Review site monitoring reports, document findings in monitoring visit tracker, and discuss all findings with Senior Clinical Program Scientist (SCPS)
  • Perform TMF QC of site documentation upon enrollment completion at CRO (Quintiles)
  • Manage study related activities in SCPS absence including but not limited to ensuring functional area representatives adhere to End of Study (EOS) timelines, provide program director with weekly and monthly study updates, lead CTT and vendor meetings, update MS Project study timelines in EPM and synchronize in CTMS, review EOS Site Completion Reports
  • Author master consent using Shire templates and collaborated with Clinical Program Scientist (CPS) and additional functional area representatives on review and approval
  • Perform vendor selection, review Request for Proposals (RFPs) and draft and final budgets, participate in vendor bid defense meetings, collaborate with procurement and legal for SOW execution
  • Interview and approve potential CRAs
  • Support three SCPS on study related activities and deliverables
  • Mentor CTAs and summer interns

Clinical Trial Associate – Clinical Development Operations (Kelly Services Contractor)

Shire, a Wholly Owned Subsidiary of Takeda Pharmaceutical Company Limited
08.2013 - 09.2014
  • Perform thorough and comprehensive QC of TMF as well as collaborated with functional area representatives to ensure completeness and accuracy of study documents in preparation for Shire's first PMDA Inspection in Japan of the rare Gaucher Disease
  • Perform periodic TMF QC of central and site documentation for several trials to satisfy internal audit and SOP requirements as well as ensure compliance with GCP regulatory requirements
  • Collaborate with functional area representatives to populate document inventories for interim and final CSR
  • Major contributor to process improvement policies including Compensation for Study Related Expenses as well as Inspection Preparation activities
  • Initiate, request and process vendor purchase order numbers for all studies
  • Primary reviewer of site monitoring reports and issue escalation identification
  • Assist SCPS in study management activities including but not limited to scheduling meetings, creating and distributing agendas, taking accurate meeting minutes and ensuring finalization within the expected timelines
  • Provide feedback on study timelines as well as other critical documents
  • Assist with preparation and review of documents for Shire's first Drug Use Results Survey (Phase IV Post Marketing Surveillance Study)
  • Coordination of sample management and facilitate communication between sponsor, CRO, and vendor
  • Provides SCPS support for Rare Disease studies conducted in India, Japan, Egypt, and Tunisia

Scientific Editor II – NCDS Management, Strategy & Operations

Millennium Pharmaceuticals, Inc. – The Takeda Oncology Company
10.2008 - 08.2013
  • Author the nonclinical (Modules 2 and 4) CTD components of an IND and lead the nonclinical functional area reviews
  • Edit nonclinical protocols, reports, and summary documents sections for INDs, IMPDs, and briefing documents
  • Populate annual updates for regulatory agencies from final reports and protocols
  • Represent the nonclinical function at cross-functional project team meetings
  • Develop, communicate, and ensure adherence to project timelines for nonclinical submissions
  • Advise documentation staff with copyediting responsibilities
  • Review work of junior editors as required

Manager – Dossier Management Group in Regulatory Operations

Millennium Pharmaceuticals, Inc. – The Takeda Oncology Company
10.2008 - 08.2013
  • Manage the successful submission of a cross-functional Supplemental New Drug Application (sNDA), including labeling changes for Millennium's marketed product, VELCADE
  • Manage four briefing book submissions to support planned sNDAs
  • Attend regular joint (Millennium & Alliance Partner) SWG meetings and significantly contributed by providing updates for briefing books and sNDA submissions
  • Lead internal (Millennium colleagues) cross-functional Submission Working Group (SWG) meetings for Millennium's marketed product VELCADE, to introduce and gain team agreement on submission timelines, content plans and to discuss and resolve outstanding issues
  • Lead internal (Millennium colleagues) cross-functional roundtables and capture resolutions for all briefing books and CTD sections of sNDA
  • Manage several annual report submissions to ensure changes were incorporated from previous drafts and major comments addressed
  • Review and revise business practices and SOPs to reflect current regulatory operation processes
  • Train new Submission Managers on responsibilities and processes related to Regulatory Operations
  • Author business practice for “Obtaining References for Regulatory Submissions” and revise documents based on submission managers' feedback

Sr. Regulatory Affairs Associate – Dossier Management Group in Regulatory Operations

Millennium Pharmaceuticals, Inc. – The Takeda Oncology Company
10.2008 - 08.2013
  • Manage the successful submission of 3 Clinical Trial Applications (CTAs) for Phase II trials for an Oral Aurora A Kinase Inhibitor to the U.S., France, Canada and Poland
  • Manage the successful submission of a Investigational New Drug (IND) Application for a Phase I/II trial for a Second-Generation Proteasome Inhibitor in the U.S. and Health Canada
  • Manage the successful submission of two Supplemental New Drug Applications (sNDA), including labeling changes for Millennium's marketed product, VELCADE
  • Manage numerous annual reports and protocol amendment submissions
  • Train new Submission Managers on responsibilities and processes
  • Develop and maintain MS Project submission timelines for cross-functional submissions
  • Coordinate, review and organize approval of submission timelines at kick-off meetings
  • Collaborate with authors to ensure submission ready documents are delivered to NexDoc, Millennium's documentum system, based on the agreed upon timeline and in preparation for publishing
  • Deliver document inventory with locators for regulatory documents residing in NexDoc to the publishing group
  • Distribute published drafts for review to reviewers through NexDoc workflows
  • Lead roundtables for all cross-functional submissions to capture resolutions on debatable topics
  • Review published output both prior to cross-functional review and submission to Health Authorities
  • Obtain sign-off from designated signatories prior to submission to Health Authorities
  • Lead cross-functional lessons learned after major cross-functional submissions

Sr. Regulatory Affairs Associate - Dossier Management Group in Regulatory Operations (Randstad Contractor)

Millennium Pharmaceuticals, Inc. – The Takeda Oncology Company
10.2008 - 08.2013
  • Plan and manage compliance-related Regulatory submissions and activities
  • Work with Regulatory leads to develop and submit filings according to agreed upon processes and timelines
  • Manage existing submission processes on multidisciplinary submission teams
  • Develop and implement process change under the direction of Regulatory Management
  • Identify issues that may delay submissions and recommend appropriate action plan
  • Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology
  • Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity
  • Prepare and maintain templates that meet Regulatory electronic submission standards
  • Assist in establishing electronic submission capability at Millennium by focusing on implementing the eCTD and representing Regulatory business function on technology teams

Regional Study Manager/CTM – Research and Development

Wyeth Research (inVentiv Clinical Solutions Contractor)
11.2006 - 08.2008
  • Manage all regional aspects for a Phase III Hematology Trial
  • Conduct site feasibility
  • Accountable for site identification, qualification, and input on site selection
  • Drive site-level timelines across the region
  • Accountable for tracking and reporting site status and enrollment across the region
  • Ensure regulatory compliance and GCP adherence across the region
  • Assist Global Trial Leader (GTL) in creating operational training materials specific to the region
  • Provide input and approve region specific portions of the monitoring plan as written by the GTL
  • Assist GTL with Investigator Meeting preparation relative to regional considerations
  • Act as secondary point of contact and point of escalation for site when Site Manager (site monitor) is unavailable
  • Ensure protocol training of Site Managers
  • Collaborate with Site Managers to complete Site Qualification Visits (SQV) and Site Initiation Visits (SIV)
  • Primary reviewer of SQV, SIV and interim monitoring visit reports (Trip Reports) to ensure completeness
  • Address all operational issues that the Site Managers are unable to resolve
  • Assist Site Managers with issue escalation and resolution of open issues
  • Support Site Managers conduct of SIV and verify sites have received all study materials and are prepared for SIV
  • Lead vendor and network meeting
  • Assist GTL with vendor setup for region by identifying vendors and ensuring contracts executed
  • Coordinate with drug supply to manage and track regional site supplies
  • Submit protocol, Informed Consent Form (ICF), Investigational Brochure (IB) and other relevant documents to Western Institutional Review Board (WIRB) for review and approval
  • Review site specific ICF prior to IRB submission to ensure all additions and deletions are captured
  • Accountable for ensuring high-quality and timely data entry into Remote Data Capture (RDC) database
  • Supervise and mentor Clinical Trial Assistants on study related responsibilities
  • Provide additional support to GTL as needed

Clinical Trial Specialist II – Research and Development

Wyeth Research (inVentiv Clinical Solutions Contractor)
11.2006 - 08.2008
  • Assist Clinical Trial Manager (CTM) with site start-up, maintenance, and close-out activities for three oncology trials (Two Phase I/II trials and one Phase III trial)
  • Obtain Confidentiality Disclosure Agreement or confirm site is on Master Service Agreement List prior to disclosure of any study related materials
  • Update study tracker regularly with all pertinent site information and correspondence
  • Send prequalification and study start-up documentation to sites (e.g. Principal Investigator Information Sheet, Electronic Preliminary Contact Form (ePCF), Investigator Brochure and supporting documents, Protocol, Financial Disclosure, etc.)
  • Correspond regularly with study file management to ensure all regulatory documents (1572, IRB approvals of the protocol and informed consent form, principal and sub-investigator curriculum vitae, financial disclosure, laboratory ranges and certification, signed protocol signature page) are received prior to site initiation visit
  • Assist with the development, revision, and ordering of the Study Reference Manual and Regulatory Binder
  • Plan Investigator's Meeting activities and assist with operations during the meeting to promote adequate flow and success
  • Complete Initial Test Article Release forms, obtain medical monitor's signature and submit to Wyeth Pharmacy to initiate test article shipment to site(s)
  • Assist site personnel with re-ordering and confirming receipt of test article
  • Arrange regular meetings with study vendors (e.g. Perceptive Informatics, Genzyme)
  • Attend weekly dose escalation/safety evaluation meetings and inquire if principal investigators have potential patients
  • Notify study team and participating sites when cohorts are open and closed to enrollment
  • Ensure all study related documentation is submitted and correctly filed in the electronic repository (EDMS) in a timely manner
  • Maintain study team roster and distribution lists
  • Take minutes at study team, vendor, and clinical research associate (CRA) meetings and submit finalized version to the electronic repository
  • Submit participate roster and all training documentation into EDMS and to prospective parties to record training (e.g. submit participate roster and training material for an amendment)
  • Submit Contract Service Agreement (CSA) to the budget department to initiate site payments
  • Maintain and distribute participant enrollment tracker to the study team
  • Assist CTM in managing vendors and/or clinical research organizations

Human Research Coordinator – Office for the Protection of Research Subjects

Dana-Farber Cancer Institute
12.2004 - 11.2006
  • Ensure potential and consenting participants achieve maximum benefits and minimal risk on Institutional Review Board (IRB) approved protocols
  • Pre-review new protocol applications submitted to the Office for the Protection of Research Subjects for Scientific Review Committee (SRC) and IRB approval
  • Pre-review and confirm consistency among protocol application, protocol document, consent form(s) and front sheet
  • Review consent form for exculpatory language and consistency with model consent
  • Prepare new protocol application packet for SRC and IRB review
  • Confirm that consenting professionals adhere to IRB approved protocol and consent form(s)
  • Ensure all additions and deletions to the protocol, consent form(s), alert page and front sheet carry over to subsequent revisions
  • Prepare amendment packets for SRC and IRB meetings and pharmacy, nursing, and radiation safety review
  • Attend SRC and IRB meetings, take minutes, and provide relevant input
  • Enter review decision in Rex Database
  • Process post-activation amendments and continuing reviews for greater than minimal risk trials
  • Train new employees on processing amendments, continuing reviews and research staff updates, and confirming CITI training for study staff

Clinical Research Coordinator II – Population Sciences

Dana-Farber Cancer Institute
12.2004 - 11.2006
  • Determine eligibility for four early detections Gastrointestinal (GI) cancer studies
  • Register consenting subjects to Quality Assurance for Clinical Trials (QACT)
  • Enter data in the Early Detection Research Network (EDRN) and Access Databases
  • Prepare and ship frozen biological and tissue aliquots to the University of Michigan for analysis
  • Compile and submit documents to implement a new protocol
  • Prepare and submit amendments, continuing reviews, study staff updates, and closure to accrual documentation to the IRB
  • Present journal article reviews on current gastrointestinal literature during staff meetings
  • Attend an EDRN conference where data on existing studies was reviewed and ideas about new protocols or expansion of existing ones was discussed

Research Study Assistant II – Epidemiology and Biostatistics

Memorial Sloan-Kettering Cancer Center
05.2001 - 08.2004
  • Determine eligibility of and recruit subjects for the “Model for Genetic Susceptibility: Melanoma” Study
  • Register consenting subjects with the Patient Protocol Accrual (PPA)
  • Conduct telephone interviews to collect data related to sun exposure, family history of melanoma and other cancers
  • Perform data management, cleaning, and analysis of subject data
  • Assist with DNA extractions
  • Present study progress at departmental meetings
  • Request diagnostic pathology slides and blocks for each pathologically confirmed diagnosis
  • Attend cancer prevention and awareness forums and co-authored a behavioral manuscript on behavior and sun exposure

Physician Office Assistant – Radiation Oncology

Memorial Sloan-Kettering Cancer Center
05.2001 - 08.2004
  • Maintain successful medical practice for two Radiation Oncologists
  • Maintain continuous communication between physicians and their patients regarding any concerns and questions pertinent to therapy
  • Schedule new visit consultations, diagnostic radiology tests, and follow-up appointments
  • Update patient charts with appropriate physician notes and test results during and upon completion of therapy
  • Utilize the following hospital software & scheduling tools: (CASPER) and DMS Patient Management System
  • Edit manuscripts and assisted in data collection for journal article submissions

Education

Master of Science - Clinical Investigation

Massachusetts General Hospital (MGH) Institute of Health Professions
Boston, MA
05.2008

Bachelor of Science - Health Service Administration

University of Central Florida
Orlando, FL
04.2004

Bachelor of Arts - Biological Science

Binghamton University
Vestal, NY
12.1995

Skills

  • Windows 11; MS Office Project; MS Teams; ClinOps Resourcing Tracker & Dashboard; ELEVATE; myAibou (including Performance Pal); Veeva Vault Clinical Suite; COMPAAS; CTMS, InterAct, Ariba, Meridian; Please Review

Affiliations

  • Healthcare Businesswomen's Association
  • American Medical Writers Association; Regulatory Affairs Professional Society

Publications

Mujumdar U, Hay J, Monroe-Hinds Y, Hummer A, Begg C, Wilcox H, Berwick M. “Sun protection and skin self-examination in melanoma survivors.” Psycho-Oncology, Accepted: October 24, 2008.

Timeline

Senior Manager, Clinical Trial Associate Team - Global Clinical Operations

Takeda Pharmaceutical Company Limited
05.2022 - Current

Diversity, Equity, Inclusion Clinical Trial Operations Lead

Janssen Pharmaceuticals
08.2021 - 05.2022

Senior Manager, Clinical Operations Program Lead – Global Clinical Operations

Takeda Pharmaceutical Company Limited
09.2020 - 08.2021

Senior Clinical Operations Manager – Global Clinical Operations

Takeda Pharmaceutical Company Limited
11.2019 - 09.2020

Senior Clinical Project Manager – Global Clinical Development Operations

Shire, a Wholly Owned Subsidiary of Takeda Pharmaceutical Company Limited
04.2018 - 11.2019

Clinical Project Manager – Global Clinical Development Operations

Shire, a Wholly Owned Subsidiary of Takeda Pharmaceutical Company Limited
09.2016 - 04.2018

Senior Clinical Trial Associate – Clinical Development Operations

Shire, a Wholly Owned Subsidiary of Takeda Pharmaceutical Company Limited
09.2014 - 09.2016

Clinical Trial Associate – Clinical Development Operations (Kelly Services Contractor)

Shire, a Wholly Owned Subsidiary of Takeda Pharmaceutical Company Limited
08.2013 - 09.2014

Scientific Editor II – NCDS Management, Strategy & Operations

Millennium Pharmaceuticals, Inc. – The Takeda Oncology Company
10.2008 - 08.2013

Manager – Dossier Management Group in Regulatory Operations

Millennium Pharmaceuticals, Inc. – The Takeda Oncology Company
10.2008 - 08.2013

Sr. Regulatory Affairs Associate – Dossier Management Group in Regulatory Operations

Millennium Pharmaceuticals, Inc. – The Takeda Oncology Company
10.2008 - 08.2013

Sr. Regulatory Affairs Associate - Dossier Management Group in Regulatory Operations (Randstad Contractor)

Millennium Pharmaceuticals, Inc. – The Takeda Oncology Company
10.2008 - 08.2013

Regional Study Manager/CTM – Research and Development

Wyeth Research (inVentiv Clinical Solutions Contractor)
11.2006 - 08.2008

Clinical Trial Specialist II – Research and Development

Wyeth Research (inVentiv Clinical Solutions Contractor)
11.2006 - 08.2008

Human Research Coordinator – Office for the Protection of Research Subjects

Dana-Farber Cancer Institute
12.2004 - 11.2006

Clinical Research Coordinator II – Population Sciences

Dana-Farber Cancer Institute
12.2004 - 11.2006

Research Study Assistant II – Epidemiology and Biostatistics

Memorial Sloan-Kettering Cancer Center
05.2001 - 08.2004

Physician Office Assistant – Radiation Oncology

Memorial Sloan-Kettering Cancer Center
05.2001 - 08.2004

Bachelor of Science - Health Service Administration

University of Central Florida

Bachelor of Arts - Biological Science

Binghamton University

Master of Science - Clinical Investigation

Massachusetts General Hospital (MGH) Institute of Health Professions

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