Fiona Shields Email & Phone Number

Basel, Baselstadt, Ch

Glasgow, Strathclyde, Gb

Glasgow, Strathclyde, Gb

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.

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

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:

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

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,

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

Post Graduate Diploma, Pg Dip Health Care Management

Post Graduate Diploma, Health And Social Services Management

Bsc Hons, Advanced Professional Practice

Nneb, Nursery Nursing

9 O Levels