Experience

Novartis UK

• United Kingdom
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Clinical Project Manager

  • Aug 2020 - Present

  Part of Novartis Business Solutions (NBS) supporting other divisions within Novartis such as; *Novartis Institute for Biomedical Research (NIBR) Clinical Sciences and Innovation (CS&I) as a Global Study Lead for early development (phase 1 and 2) translational medicine clinical studies in immunology and cardiovascular therapeutic areas. *Global Medical Affairs (GMA) as Global Managed Access Program (MAP) Lead supporting the operational set-up, maintenance and close out of compassionate use programs and post-trial access programs within the immunology / hepatology / dermatology and respiratory franchises.



Self employed

• Leeds, United Kingdom

• Senior Clinical Project Manager

  • Sep 2019 - Aug 2020

  On contract at Novartis PLS (Product Lifecycle Services) supporting Novartis Institute for Biomedical Research (NIBR) Clinical Sciences and Innovation (CS&I) as a Global Study Lead for early development (phase 1 and 2) translational medicine clinical studies in immunology and cardiovascular therapeutic areas. On contract at Novartis PLS (Product Lifecycle Services) supporting Novartis Institute for Biomedical Research (NIBR) Clinical Sciences and Innovation (CS&I) as a Global Study Lead for early development (phase 1 and 2) translational medicine clinical studies in immunology and cardiovascular therapeutic areas.



Lundbeck

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Pharmacology Study Manager

  • Oct 2018 - Sep 2019

  Study Manager responsible for the operational management of global Clinical Pharmacology studies within Lundbeck's CNS product portfolio. Key responsibilities included: *Supporting the clinical science lead with study and site feasibility for exploratory studies in fMRI and sleep. *Performing phase 1 CRO site selection visits *Drafting and co-ordinating the SOP update for vendor selection and oversight. Employed via DOCS International. Study Manager responsible for the operational management of global Clinical Pharmacology studies within Lundbeck's CNS product portfolio. Key responsibilities included: *Supporting the clinical science lead with study and site feasibility for exploratory studies in fMRI and sleep. *Performing phase 1 CRO site selection visits *Drafting and co-ordinating the SOP update for vendor selection and oversight. Employed via DOCS International.



PRA Health Sciences / Takeda

• Leeds, West Yorkshire, UK

• Senior Clinical Study Manager

  • Dec 2016 - Sep 2018

  Responsible for leading matrix clinical trial teams in the planning, implementing and reporting of all operational aspects of multi-centre international clinical trials from synopsis to report publication according to defined timelines, strict budgets, and high quality standards. Focus on early phase I and II studies in healthy volunteers and patients in the GI and CNS therapeutic areas. Supported Takeda in the transition to a new operating model within a new CRO partnership. Part of the PRA strategic solutions group in partnership with Takeda.



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Study Manager, CPS (on contract to GSK - transitioned to Novartis 1st May 2015)

  • Apr 2015 - Dec 2016

  Operational Science Lead on global Clinical Pharmacology Oncology studies. Initially supporting GSK sponsored studies which were then transferred to Novartis in May 2015 as part of the Oncology asset transfer agreement. Promoted to Clinical Trial Head in October 2015. Key responsibility was leading the clinical trial team and third-party vendors in the transition of a GSK study in start-up to Novartis during a challenging time of change and unclear processes. Employed by Parexel. Operational Science Lead on global Clinical Pharmacology Oncology studies. Initially supporting GSK sponsored studies which were then transferred to Novartis in May 2015 as part of the Oncology asset transfer agreement. Promoted to Clinical Trial Head in October 2015. Key responsibility was leading the clinical trial team and third-party vendors in the transition of a GSK study in start-up to Novartis during a challenging time of change and unclear processes. Employed by Parexel.



Novartis Institutes for BioMedical Research (NIBR)

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Trial Leader III

  • Apr 2006 - Jun 2014

  Responsible for leading matrix clinical trial teams in the planning, implementing and reporting of all operational aspects of multi-centre international clinical trials from synopsis to report publication according to defined timelines, strict budgets, and high quality standards. A focus on phase I-IIa respiratory studies in asthma and COPD. Responsibilities included: *Overall accountability for study budgets. *Maintaining relationships with key stakeholders through effective communication. *Supporting CTD submission activities *Mentoring and supervising of Clinical Trial Leaders and Fellows. *Develop and maintain relationships with external service providers/vendors. *Participation in global process improvement initiatives. *SOP writing and review.



住友ファーマ

• Japan
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Associate Clinical Study Manager

  • Apr 2005 - Apr 2006

  Support Clinical Study Manager in all operational aspects of clinical trial execution. Focus on European phase II studies. Strong focus on high level quality control processes. Responsibilities included; *Negotiating and executing agreements for investigator sites in the Netherlands and third-party vendors *CRA and site training *Site audit follow-up Support Clinical Study Manager in all operational aspects of clinical trial execution. Focus on European phase II studies. Strong focus on high level quality control processes. Responsibilities included; *Negotiating and executing agreements for investigator sites in the Netherlands and third-party vendors *CRA and site training *Site audit follow-up



Schering

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Research Associate

  • Sep 2002 - Apr 2005

  UK site monitor for local and international phase I (oncology) and III (GI, CV, Women's health) studies. Responsible for monitoring from site selection to closeout. UK site monitor for local and international phase I (oncology) and III (GI, CV, Women's health) studies. Responsible for monitoring from site selection to closeout.