Summary
Overview
Work History
Education
Skills
Vendor Experience
Publications
Timeline
Generic

Stacie Zwiesler

Wilmington,UNITED STATES

Summary

Well-qualified Clinical Data Scientist successful at cleaning and maintaining secure, accurate and efficient data. Hardworking and pragmatic with strong attention to detail and methodical approach. Prepared to offer 6 years of experience to a senior position with room for advancement. Dedicated to using excellent research, investigation and project management abilities to optimize management, organization and reporting of clinical data. Results-driven, precise and systematic with quick learning and collaborative nature. Strong history with CRO and Sponsor companies. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Overview

7
7
years of professional experience

Work History

Senior Clinical Data Coordinator

ICON
06.2022 - Current
  • Served as an external representative of the company for client and industry meetings
  • Prepared to participate in sponsor and/or third party audits
  • Responsible for local lab normal range data entry activities and identification and documentation of data problems during lab normal range tracking
  • Addresses complex data related questions and recommends potential solutions; escalates issues which potentially impact study analysis
  • Promote a positive and professional work environment and serve a temporary backup for the functional manager position
  • Supports company clinical data management initiatives to develop training for data management processes and systems
  • Manages third party data reconciliation and data review process
  • Maintains clinical data management related study documentation as appropriate
  • Reviews clinical and third party data for subjects enrolled in clinical research protocols based on edit specifications/ Integrated data review plan to facilitate data review
  • Performs duties at a high standard of quality under minimal supervision
  • Supports and executes the data review activities, including data validation and analytics, associated with a clinical trial to ensure the end product of clinical data meets agreed upon data integrity standards.
  • Resolved complex data discrepancies through detailed investigation and communication with various stakeholders.
  • Assisted biostatisticians in generating informative interim reports by providing clean and accurate data sets for analysis.
  • Served as a subject matter expert on electronic data capture systems, assisting team members in troubleshooting technical issues when needed.
  • Collaborated with cross-functional teams to develop and implement standardized data capture methods for clinical trials.
  • Upheld critical security standards when managing user access actions such as setting up and removing accounts.
  • Assisted with database upgrades and migrations by performing user acceptance testing.
  • Conducted thorough quality control checks on all collected data, resulting in improved overall data reliability.
  • Proactively identified opportunities for process improvement and efficiency gains within the clinical data management department, leading to increased overall productivity.
  • Ensured timely delivery of accurate clinical trial data by closely monitoring study progress and maintaining up-to-date documentation.
  • Demonstrates strong organizational and time management skills while managing multiple projects.
  • Apply effective time management techniques to meet tight deadlines.

Project Data Manager

SYNEOS HEALTH
02.2022 - 06.2022
  • Trains and mentors data management staff
  • Participates in, and presents at internal, Sponsor, and third-party meetings
  • Develop and maintain project plans, specifications, and documentation in line with SOP requirements
  • Plans, manages, and requests resources for assigned projects
  • Monitors and communicates project progress to the Sponsor/Client and project team including use of project reports and tracking tools/metrics to enable in-stream data collection
  • Provides project specific training to internal and external audiences as required
  • Ensures launch, delivery, and completion of all data management activities according to contractual agreements and relevant Standard Operation Procedures, guidelines, and regulations
  • Coordinate the work of the assigned data management/data operations team
  • Act as Functional Lead for Data Management including primary contact for internal liaison between data management/operations and project management, clinical monitoring and other functional groups.
  • Managed vendor relationships by establishing clear expectations, monitoring performance, and ensuring adherence to contractual obligations, resulting in strong partnerships and high-quality deliverables.
  • Reduced errors in data collection through meticulous quality control measures and regular system audits.

Principal Clinical Data Analyst

SARAH CANNON RESEARCH INNOVATIONS
05.2021 - 02.2022
  • Provide training, mentoring, guidance and oversight to junior staff to ensure accuracy, quality, and timeliness of work assigned
  • Contribute to internal process development and/or improvement
  • Communicate effectively within a multi-disciplinary project team and external resources to complete assigned tasks on time and within budget
  • Train site staff and study team members on the CRF completion guidelines
  • Develop and maintain CRF Completion guidelines
  • Work with clinical programming to develop reconciliation reports and perform data reconciliation as defined in the scope of work and/or data management plan
  • Collaborate with study team members to provide data status updates and resolve data issues
  • Produce study specific status reports as required
  • Review and query data to ensure accuracy, quality, and integrity of the study data
  • Review study specific documentation to obtain understanding of study specific data processing requirements
  • Execute data management activities in accordance with Good Clinical Practice and SOPs.

Associate Clinical Data Team Lead

PHARMACEUTICAL PRODUCT DEVELOPMENT INC.
04.2020 - 05.2021
  • Work in various EDC systems cleaning data, closing/issuing queries, and performing quality assurance for sites and client
  • Assist the functional lead in all data management processes such as SAE reconciliation, vendor reconciliation, management of local labs, audit readiness, development of new technology or tools, and risk management
  • Help maintain study documentation such as training matrix, study metrics, study related trackers and other data management documents in preparation for audit
  • Help maintain strong relationships with clients and internal cross functional teams
  • Serves as point of contact for functional manager, client, and junior associate staff on data management deliverables and obligations
  • Reviews data management deliverables
  • Monitors study metrics and run project specific status reports for management and client
  • Participates in team and client management meetings and support clinical data team lead with risk management on allocated projects
  • Creates, maintains, and files data management project documentation according to SOPs and in accordance with ICH GCPs
  • Monitors for risks to deadlines and budgets and escalates appropriately
  • Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development
  • Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met
  • Delivers study specific training, mentors, and delegates to junior associates for assigned projects
  • Applies relevant components of the project protocol to daily tasks with little to no supervision
  • Act as the assistant to the clinical data team lead for multiple projects at a time by providing support by performing assigned tasks in study set up, data cleaning, database lock and other associated tasks.

Associate Clinical Data Manager

PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD), INC.
07.2019 - 04.2020
  • Provided input for project forecasting of hours and identification of resource requirements
  • Monitored study metrics and ran study specific reports for management and client
  • Participated in team and client meetings and supported the lead data manager with risk management
  • Performed specified activities that contributed to the creation of database specifications, database build, and user acceptance testing
  • Coordinated data cleaning tasks and delegated to appropriate data management staff to ensure quality standards were met
  • Delivered study specific training to clinical data associates
  • Applies relevant components of the project protocol to daily tasks with guidance from the lead data manager
  • Acts as the assistant to lead data manager for one or more projects supporting the lead data manager by performing tasks in study start up, data cleaning, database lock, or other associated tasks.

Remote Site Monitor

PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD), INC.
05.2017 - 07.2019
  • Escalate to management any observed deficiencies or issues in a timely manner and in accordance with study communication and monitoring plan guidelines
  • Play an active role within the clinical team to help reach project goals, achieve deliverables, and meet project timelines
  • Serve as the primary contact for study sites
  • Document and assist in resolution of issues noted during site management communication
  • Conduct regularly scheduled site management calls with study site to support sites' execution of study protocol requirements
  • Perform all aspects of in-house site management in accordance with ICH GCP.

Education

Undergraduate - Exercise Science

Adrian College
Adrian, Michigan

Graduate - Exercise Physiology

University of Dayton
Dayton, Ohio

Skills

  • Quality Control
  • Protocol maintenance
  • Database finalization
  • Data Cleaning
  • User Acceptance Testing
  • Data oversight
  • Clinical Data Management
  • Data Reconciliation
  • ICH GCP
  • External Vendor
  • Teamwork and Collaboration

Vendor Experience

  • Clinical Data Management, Merative
  • Clinical Data Management, Elluminate

Publications

Body Mass Index Associations Between Mother and Offspring From Birth to Age 18: The Fels Longitudinal Study, Stacie Swanton(Zwiesler), Choh, A. C., Lee, M., Laubach, L. L., Linderman, J.K., Czerwinski, S. A., and Peterson, M. J., Stacie Swanton (Zwiesler), Obesity Science and Practice, 2016

Timeline

Senior Clinical Data Coordinator

ICON
06.2022 - Current

Project Data Manager

SYNEOS HEALTH
02.2022 - 06.2022

Principal Clinical Data Analyst

SARAH CANNON RESEARCH INNOVATIONS
05.2021 - 02.2022

Associate Clinical Data Team Lead

PHARMACEUTICAL PRODUCT DEVELOPMENT INC.
04.2020 - 05.2021

Associate Clinical Data Manager

PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD), INC.
07.2019 - 04.2020

Remote Site Monitor

PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD), INC.
05.2017 - 07.2019

Undergraduate - Exercise Science

Adrian College

Graduate - Exercise Physiology

University of Dayton

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Stacie Zwiesler