Control Supervisor Supervisor

Elizabeth Filgueiras

Project Manager

Profile

Detail oriented individual with 12 years of experience as a Project Manager with outstanding communication, leadership, and organizational skills that enhance quality and efficiency in overall company performance.

Details

Miami, 33165, 786-***-****

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Skills

Agile Project Management

Interpersonal Communication

Skills

Leadership and Management

Content Research &

Development

Budget Management

Product Development

Conflict Management

SOP Creation

Source and Protocol Review

Data Management

CRM Knowledge

Languages

English

Spanish

Employment History

PMP Consultant at Special Projects Solutions, Miami February 2017 — Present

• Defining project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility.

• Assessing project risk and proactively resolving issues.

• Lead meetings and set expectations for the project team.

• Estimating project budget and overseeing the budget throughout the project life cycle.

• Ensuring compliance with industry and government regulations.

• Tracking project timeline and budget management.

• Facilitating team meetings and following up on action items.

• Ensure resource availability and allocation.

• Perform risk management to minimize project risks.

• Create and maintain comprehensive project documentation.

• Conduct project evaluation reviews to assess how well the projects are managed.

• Delegate project tasks based on junior staff members’ strengths, skill sets, and experience.

Operations Director at Science Food Supplements and Nutrition, Miami

September 2015 — January 2017

• Working directly with shareholders (10 MD's) and reporting daily activities to Medical Director.

• Identifying and meeting with vendors and manufacturers to develop VIDA MD's products.

• Defining, implementing and revising operational policies and guidelines for the organization.

• Working with the human resources department to create job descriptions, hire competent personnel and oversee employee training programs.

• Overseeing team of content developers and nutritionists.

• Providing tasks and timelines to each department weekly.

• Liaising with departmental heads to develop financial plans and ensure company-wide compliance.

• Working closely with the marketing department and legal team to develop brand identity and ensure FDA guidelines are being followed.

• Developing the script and coordinating photo shoots, video interviews, and blog content with each MD on staff.

• Keeping track of the company's revenue margins and conducting budget reviews to minimize costs.

• Overseeing client support services.

Quality Control Supervisor at QPS MRA, Miami

October 2013 — September 2015

• Responsible for overseeing the conduct of clinical research studies.

• Overseeing quality control and data entry team at 3 different locations.

• Creating accurate and user-friendly study documentation from knowledge and understanding of the protocol, standardized formats, software applications and SOPs.

• Prepared reports on individual patients or a study population in response to investigator requests and assisted with the preparation of adverse event reports.

• Participated in protocol development with a focus on data collection.

• Analyze and evaluate clinical data including Case Report Forms

(CRF) and source documents, to ensure subject safety, investigator compliance, and site adherence with the study drug protocol, overall clinical objectives, and FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA.

• Develop clarification logs to research coordinators so they can correct the errors found.

• Prepare for Sponsor and FDA Audits.

• Review Regulatory documents and ensure they are completed.

• QC delegation logs and training sheets.

• Assist with data entry of subject files and query resolutions with the following EDC platforms: Medidata, OCRDC, Datalabs, and Openclinica.

• Provide support and timely follow-up for the implementation of clinical protocols, data collection systems, pre-post audits, quality assurance activities, and final reports.

• Quality Control Experience in the following special populations, Phases 1-4: Vaccine Trials, Oncology, Arthritis, Depression, Elderly, Healthy, Hepatic, Hypertension, Lupus, Obesity, Osteoarthritis, Parkinson’s, Pediatric ADHD, Post- Menopausal, Psoriasis, Renal, Rheumatoid, and Diabetes.

Senior Executive Assistant to Medical Director at Miami Research Associates, Miami

December 2011 — October 2013

• Responsible for developing, planning, organizing, implementing, and coordinating a variety of activities relating to health outreach and special events.

• Implementing assigned projects; coordinate project activities with appropriate staff and project partners.

• Ensure compliance and attainment of project goals and objectives in a timely manner, developing and implementing detailed work plans.

• Collect, analyze, and report data to monitor project outcomes; generate and present reports using standard formats and graphical summaries.

• Maintaining the doctor’s schedule, coordinating appointments, conferences, and business trips.

• Assuring his medical licenses are up to date and renewed.

• Performing “walk through” with medical director to assure the research facility is running smoothly.

• Managing the company/doctor’s social Medias such as Linked In, Face book, Sales Force etc.

Education

PMP

2011

Project Management Professional

Bachelor of Science Degree

2013

General Psychology

Masters Degree

March 2021 — March 2022

Currently enrolled in 2021 Fall Semester for Industrial & organizational psychology

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