Patsy Uytterhoeven Email & Phone Number

Sint-Katelijne-Waver, Be

Mechelen, Flemish Region, Belgium

Mechelen

Coordination and implementation of clinical trials projects. Management of daily activities of established clinical trials.-Accountable for successful delivery of clinical trials projects. Ensure that scope, study specifications, deliverables and timelines are consistent with corporate and client expectations, clearly documented and according to requirements.- Coordinate and implement plans associated with kits and logistics, specimen management, data management, laboratory… Show more Coordination and implementation of clinical trials projects. Management of daily activities of established clinical trials.-Accountable for successful delivery of clinical trials projects. Ensure that scope, study specifications, deliverables and timelines are consistent with corporate and client expectations, clearly documented and according to requirements.- Coordinate and implement plans associated with kits and logistics, specimen management, data management, laboratory operations and third party vendors. Coordinate timelines and resource requirements.- Ensure that validation and quality control requirements are fulfilled and documented. - Organize kick-off meetings and/or training sessions to communicate study requirements internally and externally. - Travel to attend Investigator meetings, client and site meetings to provide instructions on procedures. - Provide daily management of the project through internal and external co-ordination and follow-up during the project life cycle. - Interact with project team members and investigators to resolve and troubleshoot problems related to specimens, result reporting and site compliance. Provide sponsors and investigators with resolution to problems or refer to appropriate resources.- Review status of assigned projects through regular project team meetings. Provide additional updates and metrics to Business Development and/or Alliance Manager in support of broader global program oversight.- Proactively manage and anticipate risks to successful project delivery and escalate issues promptly.- Maintain clear and frequent communication with the client to provide project status updates. - Manage study budget and invoicing activities to ensure they are always aligned.- Maintain up-to-date project status parameters within the tracking tools and databases.- Interact with QA to participate in audits, inspections, monitoring visits, close out visits and other QA/QC issues. Show less

Lier

Develop and implement a project plan for transition to ISO15189Maintain accreditation through advice, support and training* Quality management system- Design, develop, implement, maintain and improve the quality management system according to ISO1589.- Identify and control non conformities. Implement corrective & preventive actions. Implement action plans for continual improvement. Manage resolution of complaints.- Design and negotiate SLA’s* Evaluation and… Show more Develop and implement a project plan for transition to ISO15189Maintain accreditation through advice, support and training* Quality management system- Design, develop, implement, maintain and improve the quality management system according to ISO1589.- Identify and control non conformities. Implement corrective & preventive actions. Implement action plans for continual improvement. Manage resolution of complaints.- Design and negotiate SLA’s* Evaluation and audit- Define, implement and monitor quality indicators - Implement management review and incorporate the results into goals, objectives and action plans.- Develop internal audit programs. Conduct internal audit. - Observer to the multidisciplinary fire and evacuation drill* Training: - Personnel introduction - Identify individual and departmental development needs. Design training packages. Develop introduction programs. Monitor, review & evaluate training programs. - Coaching (ISO15189, Quality in the laboratory, Internal quality audits, Quality Management System, SOP’s, Several automation projects) * Communication:- Set up and launch of communications- Relate with applicable accrediting and regulatory agencies, healthcare community. Member of “Hemovigilantie”. * Management of automation tools:- Development, implementation and management of several databases: Investment & maintenance, Documents, Personnel, Contacts, Reports, Non-conformities, Complaints Show less

Mechelen

* Business analytics: - Deliver timely, accurate and actionable business information to sales management and sales staff on a monthly basis (Ensure sales data integrity and adequate updating; coordinate with other SBU’s to achieve sales data delivery against the agreed upon timeline and objectives). Prepare presentations for BRM Sales and MBR. Manage and mentor sales staff on sales forecast, actions and reports. Preparation of the overhead budget. Ensure monitoring of the overhead data in… Show more * Business analytics: - Deliver timely, accurate and actionable business information to sales management and sales staff on a monthly basis (Ensure sales data integrity and adequate updating; coordinate with other SBU’s to achieve sales data delivery against the agreed upon timeline and objectives). Prepare presentations for BRM Sales and MBR. Manage and mentor sales staff on sales forecast, actions and reports. Preparation of the overhead budget. Ensure monitoring of the overhead data in order to closely analyze and timely adjust. Report to sales management. Quarterly compliance report. Drive, track and report standards of performance (KPI’s) on a periodic basis* Update/manage/follow-up of the Enterprise Risk Management System* Communication: - Development and content management of the sales intranet platform- Coordination of the Belgian internet website team- Set up and launch of communications* Training: - Identify individual and departmental development needs. Design training packages. Develop introduction programs. Monitor, review & evaluate training programs- Coaching on work-based trainings (SAP, intranet, applications) * Sales Procedures: Development, implementation and follow-up of Sales EMEA work instructions* Audit: Execute internal sales audits to ensure proper use of the set-up procedures and give written reports including follow-up action to sales management. * Sales tools:- Continually document, re-assess and re-design key internal procedures related to sales activities to improve efficiency, effectiveness, accountability, and profitability- Development and management of sales aspects CRM- Management of automation tools: sales intranet portal, complaints database, risk analysis tool; continuously improve tools functionality. Show less

* International fleet management: 150 corporate owned and leased cars/vans (insurances, offer process, budgets, …) * Relocation: Person in charge for all relocation issues (insurances, visa application, housing, schooling, …) * Budget: Set up of the overhead budget and budget control* Remuneration: Input and analysis of salary surveys* Communication: Set up and launch of internal communications; Management of the information database for employees and specified databases… Show more * International fleet management: 150 corporate owned and leased cars/vans (insurances, offer process, budgets, …) * Relocation: Person in charge for all relocation issues (insurances, visa application, housing, schooling, …) * Budget: Set up of the overhead budget and budget control* Remuneration: Input and analysis of salary surveys* Communication: Set up and launch of internal communications; Management of the information database for employees and specified databases * Development of policies: Car, ICT-material, credit cards, deputy, travel* Event organization: Employee satisfaction survey; staff meetings, introduction of new employees; (European) works councils; team meetings; social elections; teambuilding activities* Administrative support: of the HR Manager & HR Team (calendar, travel,…)* Editorial staff member of the company journal Show less

Medicin

Quality System Management Standard For Clinical Laboratories

Statistics In Method Validation

Certification, Internal Auditor Iso 15189

Internal quality audit regarding ISO 15189 Interpretation ISO 15189

Cum Laude, Social Legislation

Latin - Mathematics