Summary
Overview
Work History
Education
Skills
Websites
Honors Awards
Timeline
Generic

Christa Guiney

Londonderry,NH

Summary

As a Global Operations Manager at Novocure, The responsibilities were to lead and oversee the Global Operations team for the New Indications DSS (Device Support Specialist) team supporting the companies global clinical trial program, which aims to expand the use of innovative tumor-treating technology to various rare cancer types. Responsible for driving consistency, operational efficiency, planning, and implementation of key processes and services across North America, APAC, LATAM, and EMEA regions, ensuring the desired outcomes align with the company's objectives and standards resulting in over five years of experience in the global oncology biotech industry. Strong proficiency in Microsoft Office, SAP products, Asana, Vizio and various clinical systems, as well as a deep knowledge of regulatory and compliance requirements. Passionate about improving the lives of cancer patients and advancing the field of biotechnology through innovation, collaboration, and excellence. Proficient in using independent decision-making skills and sound judgment to positively impact company success. Dedicated to applying training, monitoring and morale-building abilities to enhance employee engagement and boost performance. Proven to be a collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.

Overview

5
5
years of professional experience

Work History

Global Operations Manager, New Indications

Novocure
04.2023 - 12.2023
  • Lead and oversee Global Operations team with 2 direct reports for the New Indications DSS team supporting companies global clinical trial program, which aims to expand use of our innovative tumor-treating technology to various rare cancer types
  • Managed an international team of professionals, fostering a high-performance culture and promoting professional growth.
  • Responsible for driving consistency, operational efficiency, planning, and implementation of key processes and services across North America, APAC, LATAM, and EMEA regions, ensuring desired outcomes align with company's objectives and standards.
  • Coordinated the launch of clinical trials into new global markets, ensuring regulatory compliance and seamless integration into existing systems.
  • Responsible for management and oversight of Investigator Sponsored Trials in North America and EMEA for the New Indications Team
  • Leading and maintaining cross functional communication between internal and external stakeholders
  • Spearheaded operational procedures and processes to improve efficiency and optimize operations.
  • Led weekly meetings with global staff to review progress, address challenges and drive timely task completion.
  • Devised and executed training plans for new and existing staff to support competency and compliance.
  • Enforced compliance with local, state and federal regulations and company standards.
  • Developed, enforced, and optimized internal policies to maintain responsiveness to demands and best practices to provide global harmonization amongst internal SOPs
  • Implemented key process improvements to shape organizational culture, optimize procedures for higher efficiency and help company evolve and grow support for the Global Clinical Trial program, Investigator Sponsored Trial program, and Compassionate Use Program
  • Built out a clinical SAP platform and EDC Medidata global clinical platform to be used by the patient experience team
  • Implemented clinical array waste revamp implementation to reduce waste by 35% with 12 months
  • Streamlined global operations by implementing cost-effective strategies and efficient processes.
  • Developed comprehensive risk management strategies, mitigating potential threats to company operations and assets.
  • Leveraged data analytics fro the global clinical trial pipeline and global IST program to identify trends, inform decision-making, and drive operational improvements.
  • Collaborated with cross-functional teams to align operations with corporate objectives.

Senior Operations Specialist

Novocure
04.2022 - 04.2023
  • Responsible for driving consistency, operational efficiency, developing, and implementing key processes and services to support the clinical trial program for the Global DSS, New Indications team
  • Also serves as test lead for NI DSS technologies and subject matter expert on all operational processes
  • Monitors and revises key department workflows to ensure that New Indication DSS processes are as efficient as possible, including system-based workflows, cross-functional workflows, and documentation
  • Serves as New Indications representative and subject matter expert on projects and initiatives to provide insight and suggestions to help with efficiency, success measurements/KPIs, materials creation, as needed.
  • Analyzed department metrics and performance and reported suggested and implemented process improvements based on need
  • Trained and mentored 22 lower-level employees in 3 years
  • Onboarded 10 new hire DSS's in 3 years for clinical systems and SOP adherence

Operations Specialist

Novocure
06.2020 - 04.2022
  • Collected, arranged, and built Business Object Reports to review and provide global metrics to senior leadership
  • Assisted various departments with change by communicating new improvement plans and expectations.
  • Used BOBJ to model data and forecast trends.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Developed effective improvement plans in alignment with goals and specifications.
  • Helped meet changing demands by recommending improvements to business systems or procedures.
  • Cultivated positive relationships with cross-functional partners to deliver timely and beneficial global project initiatives
  • Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
  • Tracked and analyzed reports to determine needed improvements.
  • Motivated and trained employees to maximize team productivity.

Healthcare Provider Coordinator II

Novocure
10.2018 - 06.2020
  • Serves as the single point of communications for physicians and their office support staff.
  • Operates with a strong understanding of the patient forward mission and is a collaborator with strong communication skills

Education

Bachelor of Science - Health Science

Southern New Hampshire University
Manchester, NH
01.2021

Associate of Science - Business Administration And Management

Manchester Community College NH
Manchester, NH
01.2019

Skills

  • Clinical Trial Study start up- trial close out experience
  • Clinical Pathway IST and compassionate use leadership experience in North America and EMEA
  • Global Project Management
  • Global Business Development
  • International Stakeholder Engagement
  • Global Logistics Management
  • Organizational Development
  • Forecasting and Budgeting
  • Process Improvement/ Best Practices
  • Cross-functional Team Leadership
  • KPI Tracking/ Metrics Tool Reporting
  • Department Oversight/ Strategic Planning
  • Proficient in Microsoft Office, SAP,BOBJ, Visio, SMARTSHEET, Sharepoint, Veeva and various other clinical systems

Honors Awards

Member of The National Society of Leadership and Success, THE NATIONAL SOCIETY OF LEADERSHIP AND SUCCESS, 02/01/21

Timeline

Global Operations Manager, New Indications

Novocure
04.2023 - 12.2023

Senior Operations Specialist

Novocure
04.2022 - 04.2023

Operations Specialist

Novocure
06.2020 - 04.2022

Healthcare Provider Coordinator II

Novocure
10.2018 - 06.2020

Bachelor of Science - Health Science

Southern New Hampshire University

Associate of Science - Business Administration And Management

Manchester Community College NH
Christa Guiney