Summary
Overview
Work History
Education
Skills
Custom
Languages
References
Timeline
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Emma Hawke

Emma Hawke

Eastleigh,UK

Summary

Diligent Regulatory Affairs Manager with extensive clinical research experience.

Accomplished professional with expertise in regulatory intelligence and clinical trial oversight, demonstrating strong leadership capabilities and a commitment to good clinical practice. Proven track record in team management, project management and process improvement, with a focus on informed consent procedures and training and development.

Adept at cross-functional team leadership and employee performance management, driving change management initiatives to enhance organisational efficiency. Career goals include advancing strategic leadership roles to further contribute to the healthcare sector's innovation and regulatory excellence.


Overview

13
13
years of professional experience
7
7
years of post-secondary education

Work History

Regulatory Affairs Manager

ICON plc
Reading, United Kingdom
11.2020 - 04.2025
  • Company Overview: previously PRA Health Sciences
  • Line management and sole team lead for UK and Ireland Regulatory Affairs Submissions Team.
  • Resource management for the UK and Ireland team including recruitment of new team members.
  • Implementation of new and updated company initiatives within the UK and Ireland start-up team.
  • Local Clinical Trial Applications Specialist in the UK and Ireland - serving as the primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects.
  • Direct contact with Sponsors at a global level.
  • Preparation and submission of initial applications, substantial and non-substantial amendments to regulatory bodies in the UK and Ireland including EU CTR, ARSAC, and Scientific Advice submissions.
  • Devised comprehensive strategies that resulted in expedited approval from health authorities.
  • Implementation of processes and procedures to accommodate changes in UK and EU regulations (such as EU CTR, EU CTD and post Brexit requirements).
  • Provide training and support to junior team members in more complex submissions and studies (such as GMO, Orphan Drug and combination Studies).
  • Change management. Streamlined internal processes to enhance efficiency in regulatory affairs.
  • Ensured adherence to industry standards, resulting in minimal non-compliance issues.
  • Proactively identified potential risks, thus reducing instances of non-compliance.
  • Collaborated with international teams for effective management of global projects.
  • Trained new employees effectively reducing their learning curve and increasing productivity sooner than usual.
  • Conducted thorough research on global regulations, keeping the company updated on changes.
  • Department and process change rollout and implementation.

Site Start Up Associate

Premier Research
, United Kingdom
09.2017 - 11.2020
  • Local Clinical Trial Applications Specialist - serving as the primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects.
  • Preparation and submission of initial applications, substantial and non-substantial amendments to the Central Ethics, HRA and MHRA for commercial studies the UK.
  • Safety reporting including DSUR, SUSARS, Semi Annual Line Listings and Urgent Safety Measures to EC and MHRA.
  • Essential document collection and review, ensuring that sponsor and investigator obligations are being met and follow applicable local regulatory requirements and ICH/GCP guidelines.
  • Local Investigator Contract and budget negotiations for initial CTA and CTA amendments.
  • Preparation checklist for IP release according to country regulations.
  • Providing country-level intelligence on site start-up.
  • Maintaining study start up documents in the designated study eTMF.
  • Mentoring junior members of staff.
  • Promoted to Site Start Up Associate II in September 2018
  • Liaised with clients to enhance business relationships.

Contract Regulatory Start Up Specialist

Quintiles IMS
United Kingdom
03.2017 - 09.2017
  • Responsible for the Start Up activities for designated projects in the UK including Ethics and HRA submissions.
  • Serves as the primary point of contact for the study teams (including Site Staff, Investigators, Project Managers and CRAs) during start up in the UK.
  • Responsible for contract and budget negotiations with sites in the UK. Producing site specific contracts using sponsor specific contract templates.
  • Performs local essential document collection and review for UK sites.
  • Advises on the preparation of country specific study documentation including Informed Consent Forms, Patient Information Sheets and GP letters.
  • Ensures all relevant approvals and documentation are in place for IP release to site.
  • Responsible for the processing of study amendments including Ethics and HRA submissions.

Clinical Research Associate

PRA Health Sciences
United Kingdom
02.2016 - 03.2017
  • Primary CRA responsibility of phase I and phase II clinical trials in Oncology and Haematology.
  • Performing independent monitoring visits (including PSSV, SIV, Routine Monitoring Visits and COV) at NHS and Non NHS facilities across UK and Ireland.
  • Essential document review and collection for UK sites throughout the study duration.
  • Data reconciliation and validation using Medidata Rave and Oracle.
  • Performs IP accountability at sites.
  • Responsible for study specific training of site staff including PI's and Pharmacists.

Paediatric Oncology Clinical Trial Co-Ordinator

University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
04.2012 - 02.2016
  • Setting up national and international clinical trials for the paediatric oncology unit. This includes obtaining local approvals with R&D, ARSAC applications, contract negotiations, costing and finance applications.
  • Liaising with numerous departments and clinical staff to ensure smooth running of a portfolio of over 30 phase II and III studies in set up, open to recruitment and close.
  • Processing of trial biomedical samples.
  • Monitoring, reporting and audit of trial recruitment and department data.

Education

Master's Degree (MA) - Biomedical and Healthcare Ethics

University of Leeds
United Kingdom
09.2020 - 11.2022

Bachelor of Science Degree (BSc) - Physiotherapy

University of Southampton
United Kingdom
09.2006 - 07.2009

Foundation Degree - Health and Social Care

University of Southampton
Southampton
09.2005 - 07.2007

Skills

  • Regulatory intelligence
  • Clinical trial oversight
  • Leadership capabilities
  • Good clinical practice
  • Project Management
  • Informed consent procedures
  • Process improvement knowledge
  • Training and Development
  • Cross-functional team leadership
  • Employee performance management
  • Change management

Custom

  • Gene and Cell Therapy, Phase I, Adult Advanced solid tumours immunotherapy study (including Lung, Breast, Bladder and Bowel cancer)
  • Oncology, UK, Phase I, Adult Advanced solid tumours immunotherapy study (including Lung, Breast, Bladder and Bowel cancer), Phase II, Paediatric Neuroblastoma, Paediatric Wilms Tumour, Paediatric Hepatoblastoma, Paediatric Germ Cell Tumour, Phase III, Paediatric Neuroblastoma, Paediatric Medulloblastoma, Paediatric ATRT, Paediatric Rhabdomyosarcoma, Paediatric Ewings
  • Haematology, UK, Phase II, Adult Sickle Cell Anaemia, Paediatric Acute Lymphoblastic Leukaemia, Paediatric Acute Myeloid Leukaemia, Phase III, Paediatric Acute Lymphoblastic Leukaemia, Paediatric Acute Myeloid Leukaemia, Adult Non-Hodgkin Lymphoma, Paediatric Non-Hodgkin Lymphoma
  • Neurology, UK, Phase II, Adult MS, Adult Stroke, Adult Parkinson's Disease
  • Genetics, UK, Phase IV, Paediatric Transient Neonatal Diabetes

Languages

English
Fluent

References

References available upon request.

Timeline

Regulatory Affairs Manager

ICON plc
11.2020 - 04.2025

Master's Degree (MA) - Biomedical and Healthcare Ethics

University of Leeds
09.2020 - 11.2022

Site Start Up Associate

Premier Research
09.2017 - 11.2020

Contract Regulatory Start Up Specialist

Quintiles IMS
03.2017 - 09.2017

Clinical Research Associate

PRA Health Sciences
02.2016 - 03.2017

Paediatric Oncology Clinical Trial Co-Ordinator

University Hospital Southampton NHS Foundation Trust
04.2012 - 02.2016

Bachelor of Science Degree (BSc) - Physiotherapy

University of Southampton
09.2006 - 07.2009

Foundation Degree - Health and Social Care

University of Southampton
09.2005 - 07.2007

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Emma Hawke