Summary
Overview
Work History
Education
Skills
Work Preference
Timeline
Hi, I’m

Penny Curtis

Atlanta,U.S.A.
Penny Curtis

Summary

Focused Project Manager adept at planning, directing and maintaining continuous operations in various departments. Experienced in directing manufacturing employees and keeping efficient production in accordance with quality standards. Applying creative and analytical approach to operations for continuous process improvement. Skilled at identifying or anticipating problems and providing solutions. Excels through mentoring, training and empowering team to excel in performance.

Overview

6
years of professional experience

Work History

ICON

Project Manager
04.2021 - Current

Job overview

  • Streamlined project processes by implementing Agile methodologies, resulting in increased efficiency and reduced costs.
  • Established effective communication among team members for enhanced collaboration and successful project completion.
  • Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
  • Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
  • Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle.
  • Mentored junior team members in project management best practices to enhance their skills and contribute to better overall performance.
  • Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
  • Prepared detailed reports on project status for stakeholders, ensuring transparency and alignment with objectives.
  • Negotiated contracts with vendors and suppliers, securing quality materials at competitive prices for efficient use of resources.

ICON

Senior Clinical Trial Operations Manager
07.2019 - 04.2021

Job overview

  • Responsibilities include: Meetings for assigned studies, assisting in Investigator recruitment, evaluating, initiating, monitoring, and closing out sites according to applicable Standard Operating Procedures (SOPs) and FDA Guidelines, reviewing case report forms for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirements, performing drug accountability, ensuring prompt reporting of adverse events, and verifying completeness of regulatory documents
  • Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP involvement, when required, in other areas of study management acting as the operational lead in the day-to-day management of full service studies
  • Collaborated with medical affairs teams to develop scientifically sound protocols that aligned with business objectives while meeting regulatory standards.
  • Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues.
  • Enhanced patient recruitment by streamlining the clinical trial process and improving communication with investigators.
  • Reduced study start-up timelines by effectively collaborating with cross-functional teams and implementing efficient processes.
  • Increased site compliance through regular monitoring visits, comprehensive training, and timely resolution of issues.

ICON

Clinical Trial Manager
09.2017 - 07.2019

Job overview

  • Responsibilities include: Evaluating and interpreting collected clinical data in conjunction with Principal Investigator as appropriate, prepared oral presentations or written reports and analyses setting forth progress, trends and appropriate recommendations and conclusions
  • Coordinating and implementing procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources
  • Ensuring compliance with protocol guidelines and requirements of regulatory agencies; identified problems and/or inconsistencies and Monitoring patients’ progress to include documentation and reporting of adverse events; recommended corrective action as appropriate
  • Maintaining contact with Sponsors to schedule and coordinate site visits or answer questions about issues such as incomplete data
  • Assessing eligibility of potential subjects through methods such as screening interviews, reviewed of medical records and discussed with physicians and nurses.
  • Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
  • Spearheaded the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
  • Implemented risk management strategies, effectively minimizing potential threats to the success of clinical trials.
  • Supported the preparation of clinical study reports by providing accurate data analysis and interpretation for inclusion in final documentation.

Education

University of Phoenix
Atlanta, GA

Masters of Business Administration Degree

Eckerd College
Saint Petersburg, FL

Bachelor of Science Degree from Human Resources Management

Skills

  • Extensive knowledge of ICH-GCPs, FDA regulations and the clinical trial process
  • Experience in Electronic Data Capture Trials: Inform, Medidata-Rave, Clininfo, TrialMaster
  • Experience in CTMS: Impact, eClinical, Siebel, IcoTrial
  • Document Management
  • Project Tracking
  • Work Flow Planning
  • Risk Management

Work Preference

Work Type

Contract WorkFull TimePart Time

Work Location

Remote

Important To Me

Work-life balanceCompany Culture4-day work weekFlexible work hoursWork from home option

Timeline

Project Manager

ICON
04.2021 - Current

Senior Clinical Trial Operations Manager

ICON
07.2019 - 04.2021

Clinical Trial Manager

ICON
09.2017 - 07.2019

University of Phoenix

Masters of Business Administration Degree

Eckerd College

Bachelor of Science Degree from Human Resources Management

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Penny Curtis