Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Beth Rhew

Summary

Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Overview

26
26
years of professional experience
1
1
Certification

Work History

Self Employed CEO/Manager

The Creative Goat
02.2016 - Current


  • Managed partnerships and strategic business relationships by negotiating contract terms and handling conflicts.
  • Built productive relationships with industry partners and competitors to support strategic business objectives.
  • Cultivated forward-thinking, inclusive, and performance-oriented business culture to lead industry in innovation and push progress.
  • Analyzed and tracked business metrics and made appropriate adjustments to meet supply and demand needs.
  • Negotiated with suppliers and delivery workers and ordered materials according to forecasted customer demand.
  • Identified new revenue generation opportunities to maximize bottom-line profitability.
  • Maintained professional, organized, and safe environment for employees and patrons.
  • Planned and budgeted accurately to provide business with resources needed to operate smoothly.
  • Managed and motivated employees to be productive and engaged in work.
  • Communicated clearly with employees, suppliers and stakeholders to keep everyone on same page and working toward established business goals.

Clinical Data Manager

Lykos Therapeutics
12.2021 - 09.2023
  • Successfully managed and supported data management work for various projects, ensuring compliance with SOPs, Good Clinical Practice, ICH Guidelines, and sponsor requirements
  • Played a key role in developing data management guidelines and study documentation, including DMP, DVP, CRF completion guidelines, and other essential study documents
  • Enhanced clinical trial database efficiency by spearheading formulation of eCRF design, query logic, edit checks, and data transfer specifications
  • User Acceptance Testing (UAT) of Medio EDC system by creating role-based test scripts and execution logs as well as supporting UAT for other projects, ensuring data quality and accuracy
  • Proactively managed data reconciliation activities documented in DVP, DMP, etc
  • Conducted review and reconciliation of data listings and generated queries to address data issues
  • Grant and remove access to study database
  • Contributed to therapist excellence by devising and executing training program for exceptional clinical outcome measurement, fostering superior patient care
  • Assisted in development, maintenance, and communication of department systems and SOPs
  • Maintained awareness of the CAPA process and provided input for audit responses related to assigned tasks.
  • Proven ability to learn quickly and adapt to new situations.
  • Applied effective time management techniques to meet tight deadlines.
  • Participated in team projects, demonstrating an ability to work collaboratively and effectively.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Built complex data analysis reports and provided timely feedback to stakeholders.

Real Estate Broker

Self Employed
04.2015 - 09.2019
  • Provided Strategic Financial Guidance, Conducted Comprehensive Market Analysis, Implemented Dynamic Property Marketing: Ensured Contract Compliance and Satisfaction.
  • Negotiated real estate contracts to navigate transactions between buyers and sellers.
  • Arranged for inspections and surveys of sold properties.

Family Caregiver

N/A
03.2013 - 10.2015

Training Lead/Instructional Designer

Farragut Systems
10.2012 - 03.2013
  • Collaborated closely with subject matter experts from the software development team and liaised with representatives from the North Carolina Departments of Revenue and Transportation to create and deliver extensive training materials and establish best practices for North Carolina's Tag & Tax Together program.
  • Analyzed training, student outcomes and course delivery metrics to produce reports for senior management.
  • Built and maintained professional relationships with vendors and suppliers.
  • Facilitated in-person learning sessions.

Clinical Data Management & EDC Curriculum Training Manager

IQVIA
02.2011 - 07.2012
  • Spearheaded the creation of data management-compliant curricula, training materials, standards, and workflow charts, seamlessly integrated into our Learning Management System (LMS)
  • Pioneered a content optimization initiative resulting in a remarkable 50% reduction in training content, significantly boosting learning efficiency and effectiveness
  • This achievement was accomplished through the strategic enhancement of training curricula and program delivery, aligning with focused content management principles.
  • Communicated all learning and performance objectives, schedules, and training assessments to upper management.
  • Managed development of e-learning training materials and activities to enhance learning experiences.
  • Conducted research and analysis of learning needs of employees to develop targeted training programs.

Senior Trainer, Associate Training Manager, Senior Education Specialist

IQVIA
02.2000 - 06.2011
  • Led the development and implementation of process, compliance, and system/software training programs within a dynamic clinical trial environment, resulting in highly effective data management practices
  • Successfully trained over 1,000 individuals in the proficient use of EDC systems and study-specific eCRF completion guidelines, ensuring widespread competence across diverse teams
  • Spearheaded training initiatives covering data processing, skill validation, and personal development for both new hires and existing Clinical Data Management (CDM) staff, resulting in a highly skilled and motivated team
  • Conducted training sessions on Clinical Data Management Systems, Standard Operating Procedures (SOPs), and Work Instructions, ensuring team members were well-versed in essential processes and protocols
  • Managed and meticulously maintained training records for over 200 employees, ensuring compliance and readiness for both internal and external audits
  • Actively engaged in project work as needed, effectively mitigating project overload and contributing to the successful completion of critical tasks and milestones.
  • Recruited, trained and mentored new instructors.
  • Evaluated training needs to improve training quality.
  • Reviewed and edited all training materials for accuracy and company policy compliance.
  • Developed departmental systems and procedures to better align workflow processes.
  • Built relationships with external stakeholders, community organizations and donors to increase program scope.

Clinical Data Coordinator

IQVIA
09.1997 - 02.1999
  • Proficiently managed a high-volume of data tasks, including data entry, verification, computerized consistency checks, creation and updating of Data Clarification Forms (DCFs), Quality Control, Serious Adverse Event (SAE) reconciliation, and audit-related responsibilities
  • Co-led a 20-person team, serving as a mentor to junior team members and acting as the primary point of contact for questions, task assignments with strict deadlines and reviewed work.

Education

Bachelor of Social Work -

North Carolina State University
Raleigh, NC

Skills

  • 15 years in Clinical Research
  • Regulatory Compliance
  • EDC Systems (Medrio, Medidata Rave, Oracle, InForm)
  • Effective Problem Solving and Decision-Making
  • Cross-functional Collaboration
  • Exceptional multitasking abilities with a track record of meeting deadlines
  • EPRO
  • Project Management
  • Risk Management
  • Database Design
  • Clinical Documentation
  • Interpersonal and Written Communication
  • Training and Mentoring
  • HIPAA Knowledge
  • Proficient in Microsoft Office
  • Effective Communication
  • Data Interpretation

Certification

  • Medrio 41.3
  • NC Broker License

Timeline

Clinical Data Manager

Lykos Therapeutics
12.2021 - 09.2023

Self Employed CEO/Manager

The Creative Goat
02.2016 - Current

Real Estate Broker

Self Employed
04.2015 - 09.2019

Family Caregiver

N/A
03.2013 - 10.2015

Training Lead/Instructional Designer

Farragut Systems
10.2012 - 03.2013

Clinical Data Management & EDC Curriculum Training Manager

IQVIA
02.2011 - 07.2012

Senior Trainer, Associate Training Manager, Senior Education Specialist

IQVIA
02.2000 - 06.2011

Clinical Data Coordinator

IQVIA
09.1997 - 02.1999

Bachelor of Social Work -

North Carolina State University
Beth Rhew