Fiona Shields

Fiona Shields Email and Phone Number

Study and Site Operations Country Head @ Novartis
Basel, Baselstadt
Fiona Shields's Location
Leicester, England, United Kingdom, United Kingdom
Fiona Shields's Contact Details

Fiona Shields personal email

n/a
About Fiona Shields

A highly ambitious individual who strives to achieve success. Through a high level of drive, determination and the application of interpersonal and leadership skills I have the ability to achieve demonstrable results

Fiona Shields's Current Company Details
Novartis

Novartis

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Study and Site Operations Country Head
Basel, Baselstadt
Website:
novartis.com
Employees:
5
Company phone:
+41 61 324 11 11
Company email:
eric.althoff@novartis.com
Fiona Shields Work Experience Details
  • Novartis
    Study And Site Operations Country Head (Uk)
    Novartis Jan 2023 - Present
    Basel, Baselstadt, Ch
  • Iqvia Biotech ( Formerly Clintec)
    Director Of Study Start Up
    Iqvia Biotech ( Formerly Clintec) Aug 2020 - Dec 2022
  • Clintec
    Director Of Clinical Monitoring
    Clintec May 2019 - May 2021
    Glasgow, Strathclyde, Gb
  • Clintec
    Director Clinical Operations
    Clintec Jul 2017 - May 2021
    Glasgow, Strathclyde, Gb
  • Covidien
    Clinical Research Monitoring Manager - Emea
    Covidien Jan 2014 - Jul 2017
    Fridley, Minnesota, Us
    Acting as part of the senior leadership team my role has changed over the last 12 months- Prior to integration within Medtronic I was responsible for the line management and development of the EMEA monitoring team in line with the requirements of the service-Since the time of integration my responsibilities have changed and I now have accountability for : -UK and Ire Clinical Monitoring Team - Centralised services, including administration serves, report management team ( both based in Maastricht) and the Contractors and Onboarding services all of which cover the whole of EMEA APAC regions. - Currently hold line management responsibility for 27 individuals based within UK / Ireland and the Netherlands. Remain an active partner in the clinical monitoring senior leadership team to drive and shape the future of monitoring services across EMEA -APAC.
  • Novella Clinical, Inc.
    Director Of Clinical Monitoring, Europe
    Novella Clinical, Inc. Jun 2012 - Nov 2013
    Morrisville, Nc, Us
    • Directs the performance of the clinical operational staff across Europe. Develops monitoring timelines, develops strategic goals with staff, and provides guidance as needed for completion of tasks. Assesses performance and recommends salary adjustments.• Designs, develops, and updates Standard Operating Procedures for all clinical monitoring functions.• Develops budgets and is accountable for the profit/loss for the monitoring component of each project and the overall performance of the Monitoring Department. • Develops budgets for the monitoring component of proposals in conjunction with EVP, Clinical Operations.• Assures that monitoring functions interface effectively with all other key operating departments within Novella. • Line management of a group of clinical staff (both office and regionally based). • Works with Human Resources and Novella Clinical Resourcing to recruit and hire qualified monitors to staff Novella projects.• Develops strategies to meet patient recruitment expectations.• Ensures training for the monitoring staff. Selects training curriculum for the monitoring staff. • Reviews and approves reports and manuscripts, as necessary.• Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.• Participates in business development activities
  • Novella Clinical, Inc.
    Associate Director
    Novella Clinical, Inc. May 2011 - May 2012
    Morrisville, Nc, Us
    Line management of a group of clinical staff (both office and regionally based) in the following areas:Monitors project hours and overall workloads: .Appraises performance of direct reports:Coaches, trains, and supports direct reports:
  • Novella Clinical, Inc.
    Sr Project Manager
    Novella Clinical, Inc. Jan 2008 - Aug 2010
    Morrisville, Nc, Us
    Responsible for all activities related to implementation of clinical studies including:• Project team leadership• Communicating and documenting interactions with clients based on SOPs• Defining and implementing functional standards, goals, and expectations• Defining project timelines and meeting project deliverables • Assuring thorough planning and effective implementation of trials based on contracted scope of work, project timelines, and milestones• Managing ongoing team activity• Reviewing project budgets, monitoring costs, potential overruns and implementing cost effective solutions• Reviewing and identifying project study trends and proactively responding to client and respective team members• Developing appropriate early warning systems of impending obstacles to the successful completion of the projects; analyses information and develops innovative solutions to challenges• Identifying and assisting with implementation of training need for project team• Assists in the development and delivery of capability and proposal defense presentations to prospective clients• Provides regular project reports and updates to Novella Management and clients as requested• Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually• Authorised to: o Hold client deliverables when deemed appropriate for financial or quality reasonso Negotiate deliverable timelines with clients leading to contract amendmentso Negotiate scope of work agreement with clients. (Cannot authorise variances to the scope of work)o Approve line level timesheets of all project team members
  • Tfs Trial Form Support
    Clinical Research Manager
    Tfs Trial Form Support Feb 2007 - Jan 2008
    Lund, Skåne, Se
    Global Study Manager for International Large Phase III oncology study• Management of Phase II / III Oncology projects• Conducted European Feasibility process• Planning Investigator Meetings• Budget Management• Liaison with all relevant vendors to ensure on-going quality service delivered.• Managing project budgets • Writing and preparing the Clinical Study Documentation in collaboration with the Study Team members• Coordinating and being responsible for the completion of study documentation material• Preparing and conducting pre-study activities• Ordering and organising study supplies • Preparing study documentation and assisting the Clinical Quality Assurance Manager and regulatory authorities during audits or inspections in-house or on site• Selecting and negotiating contracts with local/central laboratories,
  • Leicestershire And Rutland Cancer Research Network
    Cancer Research Manager
    Leicestershire And Rutland Cancer Research Network Jun 2002 - Feb 2007
    Key Responsibilities: Management of clinical research portfolio and clinical research service across 3 NHS Trusts, budget management. Development of quality systems and co-ordination of audit program

Fiona Shields Skills

Clinical Monitoring Cro Gcp Therapeutic Areas Clinical Trials Oncology Pharmaceutical Industry Clinical Research Edc Ich Gcp Ctms Clinical Operations Fda Clinical Development Sop U.s. Food And Drug Administration Cro Management Good Clinical Practice Clinical Trial Management System

Fiona Shields Education Details

  • De Montfort University In Leicester
    De Montfort University In Leicester
    Pg Dip Health Care Management
  • De Montfort University In Leicester
    De Montfort University In Leicester
    Health And Social Services Management
  • University Of Nottingham
    University Of Nottingham
    Advanced Professional Practice
  • Peterborough Regional College
    Peterborough Regional College
    Nursery Nursing
  • Bourne Grammar School
    Bourne Grammar School
    9 O Levels

Frequently Asked Questions about Fiona Shields

What company does Fiona Shields work for?

Fiona Shields works for Novartis

What is Fiona Shields's role at the current company?

Fiona Shields's current role is Study and Site Operations Country Head.

What is Fiona Shields's email address?

Fiona Shields's email address is fs****@****cal.com

What schools did Fiona Shields attend?

Fiona Shields attended De Montfort University In Leicester, De Montfort University In Leicester, University Of Nottingham, Peterborough Regional College, Bourne Grammar School.

What skills is Fiona Shields known for?

Fiona Shields has skills like Clinical Monitoring, Cro, Gcp, Therapeutic Areas, Clinical Trials, Oncology, Pharmaceutical Industry, Clinical Research, Edc, Ich Gcp, Ctms, Clinical Operations.

Who are Fiona Shields's colleagues?

Fiona Shields's colleagues are Eleonora Cvetkovic, Sonja Portner (Weiler), Scott Leporati, Chenchen Pei, Alexandra Mirauta, John Smith, Peak T..

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