Summary
Overview
Work History
Education
Skills
Attributes
Relevant Training
Professional Associations
Key Awards
Nee
Degree
Timeline
Generic

Eleanor Roach

Castle Cove

Summary

As an experienced Clinical Research Professional, my career is defined by a passion for bringing the pipeline to patients. I integrate a strong scientific research background with proven leadership in project and people management to translate complex challenges into clear, actionable strategies. My experience guiding teams to deliver results spans diverse therapeutic areas, including Oncology, Haematology, Neuroscience, and Inflammation.

Overview

25
25
years of professional experience

Work History

Senior Clinical Operations Lead

Roche Products Pty Limited
04.2022 - Current
  • Provided strategic leadership and end-to-end operational delivery for pivotal clinical trials across Australia and New Zealand. Managed a diverse portfolio of studies in Haematology, Breast Cancer, and Inflammatory Bowel Disease.
  • Spearheaded the site selection and feasibility strategy for a 4-study Inflammatory Bowel Disease (IBD) program. The resulting recruitment from Australian sites was a factor in the global program achieving a major enrolment milestone 5 months ahead of schedule.
  • Maintained exceptional site engagement across the IBD program by building resilient and transparent relationships with Key Opinion Leaders (KOLs) and clinical site staff, successfully navigating rapid changes in recruitment targets without compromising momentum.
  • Overcame significant initial delays and poor recruitment on a Phase 1 healthy volunteer study in New Zealand, through rapid start-up of rescue sites in Australia, ensuring all critical timelines for enrolment and regulatory filing were met.
  • Provided input on Country Landscaping for Parkinson's Disease study, for which Australia was selected as a participating country.
  • People Leader | May 2024 - Present
  • As a member of the Australian Clinical Operations Leadership Team, I lead a high-performing team of seven Clinical Operation Leads, primarily project managers, taking responsibility for their performance, motivation, and development.
  • Serious Breach Responsible | Apr 2022 - Present
  • Serving as the primary subject matter expert for Good Clinical Practice (GCP) compliance in Australia. Responsible for guiding teams in the assessment of suspected serious breaches, liaising with global quality functions, and supporting the development of Corrective and Preventive Action (CAPA) plans.
  • Disease Area Team Leader Haematology | May 2021 - Oct 2022
  • Neuroscience | Oct 2022 - Dec 2022
  • Global Study Manager | Nov 2020 - Feb 2024

Country Study Manager

Roche Products Pty Limited
09.2013 - 03.2022
  • Provided end-to-end leadership for pivotal clinical trials in the APAC region, from strategic planning through to execution and final site closure. Successfully managed complex, long-term studies across multiple therapeutic areas, consistently delivering on critical project goals.
  • Delivered Australia's commitment to the pivotal GALLIUM study, contributing to the primary analysis that enabled the successful and timely FDA filing in 2016 of Gazyva for Follicular Lymphoma.
  • Managed the strategic local wind-down of the GRAVITI trial following a global decision to end recruitment. Successfully advocated for an early site closure plan, freeing up budget and reallocating team resources to other high-priority studies.
  • Directed the successful closure of all Australian sites for the long-term GALLIUM study. Proactively managed a two-year document backlog by creating a prioritised action plan, ensuring a fully compliant closeout process.
  • Selected as the Australian representative to the Investigator Relations Community, leading the regional rollout of the Scientific Dialogue Model training to Roche and IQVIA clinical trial staff in Australia and New Zealand.
  • Identified a key inefficiency and recommended an improvement to the IXRS master consignment list process for study closures, resulting in the formal adoption of new, streamlined business rules.
  • As an active member of the Regional Country Study Managers network, drove knowledge sharing and strategic alignment for Country Study Managers and Country Study Specialists across the APAC region.

Senior Clinical Trial Monitor

Roche Products Pty Limited
04.2010 - 09.2013
  • Managed all aspects of site monitoring for pivotal trials in Inflammation, Oncology, and Haematology. Progressed to a senior role, taking on leadership responsibilities in project strategy, mentorship, and regional process improvement initiatives.
  • Selected to deliver a key presentation and facilitate a panel discussion with senior leaders at the Roche regional Asia Pacific Country Clinical Operations meeting.
  • Stepped up to support Project Managers with Lead Clinical Trial Monitor duties, including contributing to strategic decision-making, conducting site feasibility assessments, and leading site budget negotiations.
  • Co-lead the 'Future Monitor Project' locally, a key initiative designed to embed a 'fit-for-purpose' monitoring mindset and improve operational efficiencies. (A precursor to Risk Based Monitoring)
  • Planned and facilitated a successful off-site strategy meeting for the entire Australian clinical monitoring team to align on key objectives and best practices.
  • Mentored and onboarded two new clinical trial monitors, providing comprehensive training and ongoing support to accelerate their integration and performance within the team.

Country Clinical Trial Assistant

Roche Products Pty Limited
08.2009 - 03.2010
  • Provided foundational support for pivotal clinical trials in Oncology and Haematology. Mastered the role, a new industry, and complex company systems at an accelerated pace.
  • Recognised for exceptional learning agility and immediate contributions, leading to a promotion to Clinical Trial Monitor in a significantly condensed timeframe.
  • Played a lead role in redesigning the local Serious Adverse Event (SAE) reporting process, enhancing its efficiency by introducing a shared email inbox.

Postdoctoral Research Officer

The Heart Research Institute
01.2005 - 07.2009
  • Led an autonomous research project investigating the role of peroxynitrite in the weakening of artery walls in atherosclerosis. Managed all project phases, from experimental design and data analysis through to manuscript preparation and final publication.
  • Authored and successfully published five first-author research papers in high-impact, peer-reviewed scientific journals, demonstrating the ability to manage a multi-year project from conception to completion.
  • Recognised for outstanding presentation abilities, earning the 'Best Oral Presentation by a Post-doctoral Scientist' award on two separate occasions from The Heart Research Institute (2007) and the ARC Centre of Excellence (2009).
  • Supervised, trained, and mentored undergraduate students, providing direct guidance on experimental techniques, data interpretation, and scientific best practices.

Graduate Researcher

University of Sydney
03.2001 - 10.2004
  • Successfully managed a four-year research project from conception through to completion, investigating the effects of oxidative stress on red blood cell metabolism. This work culminated in the publication of four first-author papers in peer-reviewed journals.

Teacher of Biochemistry Practical Classes

University of Sydney
01.2001 - 01.2004
  • Led practical laboratory tutorials for 2nd and 3rd-year science undergraduates, translating complex biochemical concepts into clear, actionable instructions for classes of up to 30 students.

Education

PhD - Biochemistry

University of Sydney

BSc (Advanced) Honours (1st, University Medal) - Biochemistry

University of Sydney

Skills

    People Management

    Project Management

Attributes

  • Strategic thinker with a proven ability to assess risks and prioritize effectively.
  • Adept at asking insightful questions and applying a holistic view to build a comprehensive picture of capabilities.
  • Demonstrates calm and decisive judgment, comfortable making decisions even with limited information.
  • Excellent communication and collaboration skills, building strong relationships with diverse stakeholders.
  • Skilled in articulating the 'why' behind strategies, connecting concepts to create clarity for others.
  • Empathetic leader focused on drawing out the best in my team through coaching and mentoring.
  • Patient and effective teacher, able to distill complex ideas into clear and simple messages.
  • A quick and enthusiastic learner with a passion for sharing knowledge.

Relevant Training

  • Leading by coaching, 2023-09-01
  • Co-active coaching & Leadership Circle Profile, 2021-08-01
  • Scientific Dialogue Model Training, 2020-09-01
  • C3 training, 2019-10-01
  • Resilience training, 2019-07-01
  • Speak up - contribute with impact, 2019-03-01
  • Providing effective feedback, 2018-06-01

Professional Associations

The Association of Regulatory and Clinical Scientists to the Australian Pharmaceutical Industry (ARCS), 2009-01-01, Present

Key Awards

  • Roche Q4 Team Award 'For Patients - act as one team, make impact now', 2024
  • Roche Applause awards across study work and broader initiatives, 2013-2025
  • Roche Altitude award for the 'Future Monitor Project', 2012
  • Roche Excellence Award - SAE management process update, 2010
  • Best Oral Presentation by a Post-Doctoral Scientist, 2009
  • Best Oral Presentation by a Post-Doctoral Scientist, 2007
  • Gold Award for Administration of the Sydney University Women's Cricket Club, 2006
  • Sydney University Biochemistry Alumni - Most Outstanding Honours Thesis, 2001
  • Dean's Award for Citizenship in Science, 2000

Nee

Kennett

Degree

PhD

Timeline

Senior Clinical Operations Lead

Roche Products Pty Limited
04.2022 - Current

Country Study Manager

Roche Products Pty Limited
09.2013 - 03.2022

Senior Clinical Trial Monitor

Roche Products Pty Limited
04.2010 - 09.2013

Country Clinical Trial Assistant

Roche Products Pty Limited
08.2009 - 03.2010

Postdoctoral Research Officer

The Heart Research Institute
01.2005 - 07.2009

Graduate Researcher

University of Sydney
03.2001 - 10.2004

Teacher of Biochemistry Practical Classes

University of Sydney
01.2001 - 01.2004

PhD - Biochemistry

University of Sydney

BSc (Advanced) Honours (1st, University Medal) - Biochemistry

University of Sydney
Eleanor Roach