Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliations
Certification
References
Timeline
Generic

Catherine Robertson

St. Paul,MN

Summary

Results-driven Senior Clinical Project Manager known for ability to complete tasks with high productivity and efficiency. Possess specialized skills in clinical trial management, regulatory compliance, and patient recruitment stratetiges. Excel in communication, leadership, and problem-solving to deliver projects on time and within budget while maintaining high standards of quality and safety.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Senior Clinical Project Manager

NAMSA
St. Louis Park, MN
09.2020 - 02.2025
  • Managed $58 million in managing all aspects of study startup and execution of large- and small-scale, multicenter device trials.
  • Leads multiple different, multidisciplinary, cross-functional project teams, including biostatisticians, data managers, and clinical research associates.
  • Interacted with external vendors such as central laboratories, contract research organizations, imaging centers to coordinate services related to a given trial.
  • Identified opportunities for process improvement through analysis of operational processes associated with clinical trials conducted at global sites.
  • Managed resources efficiently across multiple project teams ensuring delivery according to quality standards set forth by clients.
  • Conducted periodic meetings with stakeholders to review project status and address any issues that may arise.
  • Developed and implemented project plans to ensure timely completion of clinical trials.
  • Generated timelines for protocol development, database lock, submission filing activities, and other milestones.
  • Assessed study progress and identified potential risks or delays in order to develop strategies for mitigation.
  • Organized and led cross-functional teams to manage the development, execution, and reporting of clinical studies.
  • Created onboarding program for new staff members, training in customer service and billing procedures.
  • Ensured compliance with SOPs while managing multiple projects simultaneously within budget constraints.
  • Reviewed study documents prior to submission to regulatory bodies for approval purposes.
  • Provided support and guidance to colleagues to maintain a collaborative work environment.
  • Modified project plans when needed to better align with organizational objectives.
  • Submitted budget estimates, progress reports and cost tracking reports.
  • Managed multiple projects with competing deadlines simultaneously.
  • Conducted regular status meetings with internal teams and external partners to track progress against established milestones.
  • Generated and tracked change orders and other contractual modifications affecting budget and schedule.
  • Focused on project monitoring and management by developing forecasts and tracking expenses.
  • Drafted reports summarizing progress made on projects for review by executive leadership team.
  • Reviewed budget and subcontractor estimates in detail and analyzed for accuracy with scope of work relevancy in mind.
  • Coordinated resources across multiple departments and teams as needed for successful completion of projects.
  • Developed and maintained project plans, timelines, and budgets.
  • Provided guidance to team members regarding tasks assigned to them.

Project Manager

ThreeWire
St. Louis Park, MN
07.2018 - 09.2020
  • Communicated effectively with stakeholders to ensure project goals are met on time and within budget.
  • Drove continuous improvement of project delivery process by providing strong leadership.
  • Manage over 5 million in project budgets across multiple projects, invoicing and monthly forecasting to ensure projects are on track and within budget
  • Manage multiple clinical trial projects to support patient recruitment and manage cross-functional teams to drive project results, support client needs and oversee expectations to ensure timelines are met within scope and budget
  • Main client facing point of contact to support client and clinical trials through regular project meetings, providing updates and project status, answering questions and addressing changes in scope
  • Function as a team member of Subject Matter Experts and train new staff following company training guidelines, updating materials reaching out to new staff
  • Serve as lead for internal LEAN process improvement team
  • Generate client metrics and reports through data analysis for internal and external stakeholders.

Global Product Manager

Bio-Techne
Minneapolis, MN
03.2017 - 07.2018
  • Managed over 8MM in product revenue contributing to 35% growth worldwide
  • Effectively manage three product categories and provide direction to product extension opportunities leading to 10 successful commercial products
  • Executed the largest global product launch to date in collaboration with marketing and sales to achieve over $6M in revenue in under one year through successful execution of product roadmap and go-to-market strategy
  • Develop, excecute and update internal and external communication and collateral
  • Provide collaborative leadership of Development, Operations, Commercial and Marketing teams interacting with all levels of management
  • Initiate and drive business strategies supported by ongoing internal/external analysis and industry knowledge
  • Liaison between the organization and the customer; driving voice of customer into business and product strategies
  • Develop commercial pricing strategies and recommendations

Research Associate/Supervisor

Bio-Techne
Minne, MN
09.2010 - 03.2017
  • Collaborated with sales and customer care to create product development timelines, budgets, and manufacturing capabilities.
  • Provided oversight on projects to manage expectations, timelines, and mitigate project creep.
  • Planned, coordinated, and directed the workflow and resources for GMP production labs.
  • Executed large-scale manufacturing of proteins and antibodies.
  • Implemented and drove GMP processes for an ISO 9000 organization.
  • Recognized for top performance through fast-tracked promotions, and selection for increasingly responsible positions.

Education

Master of Science - Management of Technology

University of Minnesota
Minneapolis, MN
05-2010

Bachelor of Science - Genetics, Cell Biology And Development

University of Minnesota
Minneapolis, MN
06-2003

Skills

  • Training and mentoring
  • Clinical operations
  • Patient recruitment
  • Clinical trial management
  • GCP trained
  • Project planning
  • Study payment distribution
  • Budget control
  • Audit preparation
  • Stakeholder communication
  • Master file management
  • Budget forecasting
  • Maintain budgets
  • Budget tracking
  • Standard operating procedures
  • Bid defense

Accomplishments

  • Collaborator of the Year Award at Bio-Techne - 2016.
  • In 2017, I was selected as the figurehead of Bio-Techne’s EPIC (Empowerment, Passion, Innovation, Collaboration) values, leading a team of more than 30 EPIC ambassadors globally.

Affiliations

  • Volunteer Ultimate Hiker Alumni with CureSearch - I have hiked four ultimate hikes of 25+ miles in one day and helped raise over $100,000 for children's cancer research.

Certification

  • Project Management Professional Certified

References

References available upon request.

Timeline

Senior Clinical Project Manager

NAMSA
09.2020 - 02.2025

Project Manager

ThreeWire
07.2018 - 09.2020

Global Product Manager

Bio-Techne
03.2017 - 07.2018

Research Associate/Supervisor

Bio-Techne
09.2010 - 03.2017

Master of Science - Management of Technology

University of Minnesota

Bachelor of Science - Genetics, Cell Biology And Development

University of Minnesota

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