Melissa Goodwin, MPAP
Global Project Manager, Respiratory Clinical Trials at ERT- Claim this Profile
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American Sign Language -
Topline Score
Bio
Credentials
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Communication Foundations
LinkedInMay, 2020- Nov, 2024 -
Social & Behavioral Research
CITI Program, A Division of BRANYSep, 2017- Nov, 2024
Experience
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ERT
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Global Project Manager, Respiratory Clinical Trials
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Jun 2021 - Present
Independently lead the Planning and Setup, Monitoring, and Closeout phases of 9+ respiratory clinical trials aligned with 2019 ATS/ERS spirometry guidelines ensures that all respiratory diagnostics carried out are in line with international standards for accuracy and reporting- specifically:Developing study documentation.Distributing/tracking equipment.Creating/distributing reports.Archiving study data and documentation.Appropriate setting and fulfilling of customer expectations.Leading internal and external stakeholders Perform quantitative and qualitative risk management and mitigation for assigned studies.Develop and execute User Acceptance testing scriptAccountable for trial study timelines, finances & budgets (overseeing budgets ranging from 100,000.00 - 2,500,000.00) , change order scoping, and service delivery quality of each program/study.Client facing role - Develop and apply problem-solving strategies to address customer questions/issues and identify potential study risks and mitigations and escalate while monitoring clinical trial progress and ensure timely resolution to customer escalations.Regulatory experience - maintain compliance with HIPAA, European General Data Protection Regulation (GDPR), and Good Clinical Practice (GCP) standards through internal and external trainings Manage internal/external negotiations and promote collaboration to foster a positiveteam environment, effective communications, and efficient use of resources to meetstudy timelines and contractual obligations.Therapeutic Clinical Trial Specialties- focus on long term and safety efficacy of various compounds- Idiopathic Pulmonary Fibrosis (Phase 2), Chronic Obstructive Pulmonary Disease (COPD)/( Phase 2), Cystic Fibrosis (Phase 3), Chronic Kidney Disease with Associated Severe Pruritus (Phase 2), Pulmonary Emphysema (Phase 3)
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Penn Medicine, University of Pennsylvania Health System
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United States
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Hospitals and Health Care
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700 & Above Employee
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Project Manager (Lead), Radiation Oncology, Proton Therapy, Operations
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May 2019 - Jun 2021
*Leverages knowledge for competitive advantage through application of UPHS clinical research, continuous improvement, performance management, and competency development. • Ensures all project deadlines are met. • Works collaboratively with administration, clinical staff, & vendors to ensure the project team is functioning properly and communications are open. • Communicates and ensures compliance with organizational competencies and service standards among faculty, staff, and suppliers. • Proactively enlists the support of other departments in maintaining the performance of existing systems and resources which enable the delivery of quality care. • Sets departmental project focused performance expectations by creating performance plans with clearly articulated goals and measures. •OPERATIONS- Project Risk Assessment, manage project performance, manage proton team meetings, minimize project risk, endures quality assurance and accrediting and regulatory standards are met, develops project processes in alignment with UPHS changes, new regulatory & accrediting guidelines, evidence-based practice, and personal constructs*Accountable for all data reporting on projects, specifically projects relating to proton activities and QA.
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Research Assistant
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Jul 2018 - Jun 2019
Coding and transcribing audio data for the Consortium for Policy Research in Education (CPRE); remote position Coding and transcribing audio data for the Consortium for Policy Research in Education (CPRE); remote position
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The Pennsylvania School for the Deaf
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United States
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Education Administration Programs
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100 - 200 Employee
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Project Manager, Data and Compliance
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Jun 2015 - May 2019
● Coordinates Director of Academic Affairs and Elementary, Middle, High School Principals through interdepartmental collaboration in the day to day management ● Provide administrative support by coordinating schedules, programs, alumni meetings, maintaining and organizing office files and e-files on Google Drive● Facilitate communication between internal teams and administrators across departments● Organize and monitor team schedules and see that deadlines are met● Coordinates absence management system for over 300 staff● Monitored and Assisted with the implementation of a new absence management system and professional development system ● Prepares and analyses staff and/or student data for final reports● Monitors ongoing State and Local student Assessment projects ● Assisted with recruitment, scheduling, and running reference checks for the HR Department ● Book and organize travel arrangements for Administrators ● Resolve Administrative problems ● Provides technology training for current and newly hired Staff ● Report updates verbally and in written form to management through analytical reports and memos ● Maintain database of employee feedback related to subs and sub system – eSchool solutions● Complete desk research for special projects to inform management● Purchasing, budget, and expense management of K-12 materials● Maintains records in PowerSchool, including - inputting student data
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Paraeducator (Elementary, Middle, High School)
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Aug 2014 - Jun 2015
Assisted students in achieving academic, social, and behavioral successConsulted and collaborated with Support Staff and Teachers to meet milestones within the Student’s Individualized Education Plan (IEP)Attended weekly seminars focused on early detection of Autism, Responsive Classroom tactics and behavior tactics
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Research Assistant II
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Jan 2013 - May 2013
• Coded Behavioral data of parent-child dyads• Data entry in PASW Statistics 18.0 (SPSS)• Recruited families to participate in lab studies• Literature discussions exploring the role of gesture in language development • Coded Behavioral data of parent-child dyads• Data entry in PASW Statistics 18.0 (SPSS)• Recruited families to participate in lab studies• Literature discussions exploring the role of gesture in language development
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Research Assistant I
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Aug 2012 - May 2013
• Conducted EEG studies with undergraduates to investigate brain activity during action processing• Conducted EEG studies with infants to investigate development of social cognition• Used Video Coding System to identify infant movement patterns for further analysis • Conducted EEG studies with undergraduates to investigate brain activity during action processing• Conducted EEG studies with infants to investigate development of social cognition• Used Video Coding System to identify infant movement patterns for further analysis
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Philadelphia University
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United States
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Higher Education
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400 - 500 Employee
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Resident Assistant, Main Staff, Philadelphia University
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Aug 2010 - May 2011
Supported thirty-seven residents in a Sophomore and Upper Class residence hall, promoting a sense of community on the floor.Collaborated with other staff members to organize building events every semester to promote healthy living and interaction between the floors. Recruited residents in the building to volunteer at the ING Rock & Roll ½ marathon event, which resulted in a twenty-person turn out at 5 a.m. Facilitated monthly hall meetings to help residents interact with one another through the planned group activities. Recommended to become a CHOICES peer facilitator, an in-house education program for first-time violators of campus alcohol policy as a result of communication skills developed through the Resident Assistant position.
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Education
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2016 - 2018
American University
Master’s Degree, Public Administration and Policy -
2011 - 2013
Temple University
Bachelor of Arts (B.A.), Psychology -
2009 - 2011
Philadelphia University
Bachelor of Arts (B.A.), Psychology
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