Ingrid Meeus

• Manage Country Operations Leads and resourcing in accordance with organization's policies and applicable regulation. Oversight of EMEA Countries.
• Accountable for financial results. Analyze and review budgets for EMEA countries. Able to act pro-actively on Revenue/Cost of Revenue and makes strategic choice
• Responsible of Operational Delivery of all models in the designated countries
• Develop country specific improvement plans for below-target KPIs and other performance measures
• Responsible for all Quality delivered by FSP staff in EMEA countries
• Participate in Local sponsor meetings as appropriate.
• Provide a leadership role in countries resourcing process through continual evaluation of existing and futures resources alternatives/needs, proactive planning and collaboration with Staffing Team
• Implementation & direction of regional strategy at EMEA countries level aligned with global FSP model principles and guidance.

• Manages and provides leadership to Clinical Operations Staff, including the supervision of more senior level clinical operations management positions in the assigned Business Unit and region.
• Supports the development of the regional staff plan, identifying needs to hire new staff in a timely fashion and oversee the talent acquisition process in the assigned country. Proactively works to ensure staff retention and turnover rates remain within expected levels.
• Manage and control the financial performance in the assigned country(-ies) or region(s) within the assigned Business Unit, ensuring that departmental targets are met for utilization, gross profit, revenue realization and cost control (including contractor use and staff overheads).
• Analyzes resourcing capacity and ensures a consistent quality of services and balanced work team.
• Assures clinical operations delivery, manages escalated project and site related matters to drive follow-up action plans and improve departmental procedures.
• Liaise with other departments and business units to establish harmonized clinical operations practices, processes and tools.
• Participates in the financial review of project status and drives project financial performance, particularly as related to clinical operations services.
• Provide support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required. May participate in marketing activities, client presentations and proposal development.

• Provides leadership, direction and management to Clinical Operations staff in the assigned area.
• Provides training, consultation and oversees quality related for operating activities of assigned staff to ensure project deliverables are met.
• Acts as primary point of contact for resourcing escalations, assuring utilization, performance and development of Clinical Operations staff.
• May liaise with other departments or business units to optimize resources as well as to establish harmonize clinical operations practices, processes and tools.
• Contributes to operational initiatives.
• Support the assessment of overall regional Clinical Operations staff growth and actively participate in the selection and hiring process. Proactively works to ensure staff retention and turnover rates remain within expected levels.
• Identify needs and may make recommendations for process improvement and efficiencies. Participate in committees and work groups to support the development and implementation of new initiatives and strategic direction of the TBU and cross-TBU Clinical Operations.
• May provide support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required. May participate in marketing activities, client presentations and proposal development.

• Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned area.
• Provides training, consultation and oversees metric compliance and quality related to operating activities of assigned staff to ensure project deliverables are met.
• Participate in managing the resource availability for the assigned staff/region, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions.
• Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
• Assist in recruiting new staff, including participation in interview process and new hire on boarding. Proactively works to ensure staff retention and turnover rates remain within expected levels.
• Works closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors. Able to contribute to BU level process improvements. May provide business development support.
• May conduct various types of sign off and assessment visits to ensure Clinical Operations on-site performance. Develop and oversee training plans to address performance deficiencies. Ensures staff adheres to training guidelines, training records are maintained and individual and corporate training needs are identified and addressed.
• Organizes and chairs clinical staff meetings at regular intervals. Manages issues and provides follow up for action items requiring resolution.

• Allocated workload and site assignments within the clinical monitoring team
• Reviewed monitoring reports within the timeliness mandated by SOPs or monitoring plans
• Ensured quality of the clinical monitoring deliverables within a project and maintain proper visibility of its progress by use of tracking tools
• Ensured efficient dissemination of information across the CRA team
• Interacted with the client and other functional departments related to clinical monitoring activities and deliverables
• Ensured alignment of clinical activities to budget
• Supported the identification of out of scope activities including the completion of clinical monitoring aspects of change orders
• Participated in business development proposals, defense meetings and proposal development
• Acted as Project manager on regional studies with limited scope of work
• Created and delivered project level CRA training such as clinical monitoring plan, clinical monitoring aids and annotated visit reports
• Oversee, coach and mentor project staff
• Attended Bid Defense Meetings

• Performed site visits and monitor activities in accordance with protocol, ICH-GCP guidelines, and other applicable regulatory requirements
• Mentored CRAs on monitoring, internal procedures, and query resolution and performed Quality Assessment Visits
• Understanding project scope, budgets, timelines and provide input and manage projects objectives to meet timelines
• Acted as a liaison between the sponsor and study site personnel and be able to respond to site concerns and questions
• Reviewed and verified Case Report Forms and other clinical data for completeness and accuracy

• Created and delivered project level CRA training such as clinical monitoring plan, clinical monitoring aids and annotated visit reports and ensure efficient dissemination of information across the CRA team
• Co-ordinated the development and communication of the study start-up plans and project-specific procedures, guidelines, documents and forms, in line with relevant SOP's, ICH-GCP and local requirements.
• Defined the roles and responsibilities of the Clinical Monitoring project team members and delegate monitoring activities as appropriate. Set priorities Clinical Monitoring team and ensure deadlines are maintained.
• Reviewed all site visit reports within timelines produced by the members of the Clinical Monitoring project team
• Oversee, coach and mentor project staff
• Bid Defense Meetings attendance
• Assisted the Project Manager and performed Project Management Tasks

• Coordinated of all country-specific training
• Delivered all training to the Belgium office
• Acted as advisor to the department on training needs and processes
• Performed Training Visits with trainee CRAs and new hires
• Performed visit report review and Quality Assessment visits

• Training and Development: coordinated the local implementation, follow up and delivery of training on Global and Local Procedural Documents for the Medical Department
• Quality control: Performed Quality Control of study related documents
• Quality control: Performed internal audits and Quality Assessment visits
• Acted as Line manager of the Clinical Process Manager Assistant
• Trained and mentored the new employees in the Medical Department
• Training and Development: coordinated the local implementation, follow up and delivery of training on Global and Local Procedural Documents

• Participated at meeting's: Study meeting, Monitors and Investigator Meeting attendance
• Performed Ethics Committee submission & Study initiation preparation & contract negotiation
• Performed Feasibility of Clinical Studies
• Performed Site visits: Pre-study, Initiation, Monitoring & Close Out visits
• Assisted the Project Manager and performed Project Management tasks
• Mentored junior CRAs

• Participated at meeting's: Study meeting, Monitors and Investigator Meeting attendance
• Managed Web Based Data Capture (WBDC) tools: eClinical experience in clinical trials
• Performed Ethics Committee submission & Study initiation preparation
• Performed Feasibility of Clinical Studies
• Performed Site visits: Pre-study, Initiation, Monitoring & Close Out visits

• Participated at meeting's: Study meeting, Monitors and Investigator Meeting attendance
• Managed Web Based Data Capture (WBDC) tools: eClinical experience in clinical trials
• Performed Ethics Committee submission & Study initiation preparation
• Performed Feasibility of Clinical Studies
• Performed Site visits: Pre-study, Initiation, Monitoring & Close Out visits