Experience

Boyds

• United Kingdom
• Business Consulting and Services
• 1 - 100 Employee

• Director, Clinical Operations

  • Mar 2022 - Present



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Associate Director, Early Clinical Development

  • Mar 2019 - Mar 2022

  • Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles.• Supervise team performance against contract, customer expectations, and project baselines.• Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings and own the implementation of appropriate corrective action plans.• Participate in proposal development, influence the scope and budget development of proposals for new work, including the study management costs. Escalate out of scope requests to management.• Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. Mentor less experienced CPMs.• Prepare and present project information at Senior Management meetings.• Lead key workstreams relating to ICH E6 R2 and the implementation and management within the department• Portfolio Oversight Lead for a key partnership within IQVIA

• Acting Associate Director, Early Clinical Development

  • Jun 2018 - Feb 2019

  • Completion of responsibilities to that of the previous role but with additional responsibility of the management of 4 team members within the Clinical Project Management department and assist with department management whilst the Head of the Project management team was on maternity leave• Oversee the resourcing and study allocation for the department resources• Continue with a full suite of project management with global Sponsors and sites• Input and presentation for Bid Defense meetings and Request for ProposalsProgramme Management of two valued Sponsors within the Clinical Project Management department



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Clinical Project Manager

  • Dec 2013 - May 2018

  • Completion of responsibilities to that of the Clinical Project Manager role in addition to the responsibilities expected of a senior position.• Manage the execution of clinical study(ies) per Contract, ensuring that all clinical study management and project deliverables are completed to the Sponsor’s satisfaction.• Ensure quality deliverables are on time, within budget and in accordance with SOPs, policies and practices.• Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team

• Clinical Project Manager

  • Jun 2012 - Nov 2013

  • Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.• Develop study management plans.• Primary contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.• Lead problem solving and resolution efforts to include management of risk, contingencies and issues.• Identify quality issues within the study to implement appropriate corrective action plans.• Provide input for the development of proposals for new work and manage project budgets.• Manage the financial aspects of studies, highlighting the need for a change in scope and budget amendment as necessary

• Senior CRA

  • Aug 2011 - May 2012



St George's University, London

• Clinical Trials Monitor

  • Sep 2010 - Aug 2011

  I am responsible for the essential monitoring of non-commercial clinical research studies (EU CTIMPs and non-CTIMPs) within SGUL and SGHT, to ensure compliance in accordance with Good Clinical Practice Guidelines (GCP), the Research Governance Framework for Health & Social Care (2005) and the Medicines for Human Use (Clinical Trials) Regulation 2004. I work closely with the Clinical R&D Manager and Research Governance Support Officers to provide monitoring provisions for SGHT and SGUL sponsored clinical trials, regulatory compliance advice and support for clinical researches during clinical trial set up in order to ensure that they are fully compliant with GCP, statutory requirements, and Sponsor’s processes and procedures. I am also responsible for ensuring that all ongoing clinical trials hosted by either SGUL and/or SGHT are being undertaken to the appropriate standard.I lead the development of key study documents (e.g. Protocol, Patient Information Sheets, Informed Consent Forms and Case Report Forms). I also liaise directly with the Investigator in the collation and submission to the REC and MHRA. As well as oversee the running of the trial from study set up to closure. I have been closely involved in the development of the offices new Quality Management System as well as participating in a successful MHRA inspection.



GFA

• CRA

  • Jan 2008 - Aug 2010

  Responsibilities:•Management and monitoring of study centres from feasibility, site selection and pre-study visits to closure visits •Assisted in database lock in approximately 5 studies•Provision of study specific training in the studies therapeutic area•Preparation and submission of periodic safety and progress reports•Documentation management and archiving as well as maintenance of Investigator Site file and Pharmacy file at site•Coordination of site specific submission to R&D departments•Organisation and liaising with sites and sponsor in the delivery and ordering of IMP to site •Ensure sites are running the study in accordance with the protocol, SOPs and ICH GCP and UK legislation



Gregory Fryer Associates

• Clinical Research Co-Ordinator

  • Apr 2007 - Dec 2007

  Responsibilities:•Production and maintenance of Site Investigator files, Pharmacy files and Trial Master File•Review, completion and collation of Ethics Applications•Quality control of completed case report forms•Generating patient information sheets Responsibilities:•Production and maintenance of Site Investigator files, Pharmacy files and Trial Master File•Review, completion and collation of Ethics Applications•Quality control of completed case report forms•Generating patient information sheets