Cari Jacobs-Blom Email & Phone Number

Breda, Nb, Nl

Maarsen, The Netherlands

Responsible for Good Clinical Practice (GCP) oversight and assuring the quality and compliance of Clinical projects and programs (Phase I through Phase IV). Ensure in direct collaboration and partnership with Clinical Operations, the implementation of the CR2O Quality Manual and Quality Management System in Clinical Operations to achieve a high level of quality and compliance.Responsible for training and development of Clinical Operations employees.Key tasks & responsibilities:- Implement and maintain a Quality Management System.- Ensure all CR2O employees are trained and work according to high quality standards.- Responsible for in-process quality and compliance review through monitoring of adequate Key Quality Indicators and assure that gaps are addressed appropriately in order to mitigate risk. - Responsible for vendor assessment and/or qualification. - Partner with head clinical operations in the preparation, execution and follow-up of audits on clinical operations activities. Determine root causes for country-specific major and critical audit. Verify that appropriate corrective and preventive actions are implemented on all major and critical audit findings.- Ensure, where appropriate, interface/communication with authorities for any GCP related activity.- Ensure readiness for all GxP (non-GMP/GDP) regulatory inspections.- Provide support prior to, during and after HA inspections of the Clinical Operation, investigational sites or external service providers, as applicable. Ensures that responses to local Health Authorities have been submitted, commitments have been met and relevant CAPAs have been completed/closed.- Ensure conduct of adequate training at the Clinical Operations for all GCP activities by defining, planning and supporting training activities.- Ensure that the clinical computerized systems are adequately identified during the High Level Risk Assessment for GxP relevance to enable their validation where required.

Amsterdam Area, Netherlands

Main role is to lead and participate in improvement projects, to oversee detailed process, procedural document and training development. Contribute to the development of a quality system that enables the Global Clinical Development organization to conduct clinical trials in an efficient and compliant way.Responsibilities include:- Accountable for a larger section of the procedural framework and work with partners from the business and other quality functions to ensure the process meets their requirements and aligns with their operations.- Ensure that GxP and similar requirements are adequately described.- Responsible for implementation, improvement and design projects related to the procedural framework for GxP and business processes, either as leader or key team member.- Design and implement Role Risk based training plans.- Training development and roll-out.

Rotterdam, The Netherlands

Main role was to lead the department of Clinical Operations by creating conditions which will allow employees to function optimally to ensure the department will deliver clinical trials within agreed budget, resources and timelines, with high quality and in accordance with the organizational strategy, principles and goals.Responsibilities included:- Oversight of all Clinical Operations responsibilities within all clinical trials.- Strategy for Clinical Operations.- As head of the Clinical Operations department managing the safety team (6 people), the internal Clinical Operations team (30 people, Managers Site Management, CTAs, CRAs and lead CRAs) and the external CRA team (over 60 freelancers across Europe). Ensure that all employees keep their knowledge up to date by drawing up training plans and facilitate training based on quality needs, competency or personal needs, updates in laws and regulations or internal processes.- Line management and coaching of 4 Managers Site Management responsible for the internal and external team and vendor management (outside Europe) and the Safety Officer responsible for the safety team. With this team and in cooperation with the project managers, resource management of the clinical trials.- Contribute to the operational policy of the organization by promoting cooperation with other departments and liaise with the other department heads. Member of the Cardialysis Management team with an active contribution to decision-making within the organization.- Advising the Business Development department, in collaboration with the Project Manager, on budget proposals for new Clinical trials. Owner of, and expert on the deliverables with associated hours/ budget of the department.- Development and optimization of processes and related procedures and systems to enhance efficiency and guarantee high quality of the clinical trials.

Hoofddorp, The Nethelands

Main roles are management of the Regulatory & Start-Up teams in the Netherlands, Denmark, Finland & Sweden (including start-up in Norway and Icekand from those countries) and member of the Western Europe & Africa RSU Management Team.As of January 2015: Global Subject Matter Expert Role on Translations.Responsibilities include:- Oversight of all Regulatory and Start-Up responsibilities in the Netherlands, Denmark, Finland, Iceland, Norway and Sweden.- Line management and coaching of the line managers within RSU in those countries. Team of 30 people, 4 line managers.- Member of the Western Europe & Africa RSU Management team.- Special focus on cross-border delivery in my country mix.- SME Translations: global responsibility for centralized translations process. Issue escalation and resolution, mediation between end user and the 2 contracted Global Translation Vendors.

Hoofdorp, The Netherlands

Main roles were member of the strategic management of the Clinical Operations department and Manager of the Dutch site start-up (SSU) team.Responsibilities include:- Management and coaching of the Dutch SSU team. Team of 15 people.- Line management of part of the SSU team as well as of a Manager ClinOps – SSU (who is responsible of the rest of the SSU team).- Represent NLD SSU within the Western European Integrated Site Services team.- Member of the European SSU Management team.- Resources management and liaison with Clinical Teams and project management.- Strategy for Clinical Operations.- Special focus on development and coordination of training for the department Clinical Operations.- Member of the Global Line Managers Support office.

Hoofddorp, The Netherlands

Main roles were member of the strategic management of the Clinical Operations department and line manager of Clinical Team Leads (CTL) and Clinical Trial Assistants (CTA) supporting CTLs (15 people).Responsibilities include:- Management, line-management and coaching of global and regional CTLs. - Management, line-management and coaching of CTAs supporting international CTLs.- Resources management and liaison with Clinical Teams and project management.- Strategy for Clinical Operations.- Special focus on development and coordination of training for CTLs and CTAs.

Leiden, The Netherlands

Main roles were 1) member of the strategic management of Infrastructure & Operations. This central service department was integrated with and supporting the Clinical Research department as well as supporting Regulatory Affairs, Pharmacovigilance and Therapeutic Area in BIO R&D Europe. 2) Line management and 3) content expert on Safety Information related processes and Records management.Responsibilities included:- Safety information; content expert and process owner.- Records Management; Records Management coordinator for BIO R&D Europe and content expert.- Management, line-management and coaching of the Infrastructure Support Group; group consisting of secretaries, and CTAs; responsible for the administrative and logistic support of the Clinical Trials Management department. - Process improvement in general.

Leiden, The Netherlands

Main role was managing and developing training strategies, activities and processes and coordination of general process development both in close cooperation with and supporting the Clinical Research department.Responsibilities included:- Development and training of procedural documents.- Facilitate and give training on Clinical Research related topics (e.g. GCP, legislation etc.).- Provide support with issues regarding GCP and legislation with regard to clinical research (ICH-GCP, EU-CTD, SOPs etc.).- As trainer being responsible for the implementation by training of the Clinical Trial Directive in BIO R&D Europe.- Process improvement in general.

Haarlem, The Netherlands

- Phase II and III clinical studies (Infectious Diseases, Cardiovascular, Psychiatry, Rheumatology, and Oncology): Project management and partly site management with monitoring.- Development of a filing system in house and at the investigational sites for all clinical studies.- Development and training of Standard Operating Procedures.- Internal expert on legislation with regard to clinical research (GCP, WMO, CCMO).- Application management of Clinical Trial Management software System (IMPACT); system administration, internal helpdesk, training.

Tilburg, The Netherlands

Phase II and III clinical studies (Infectious diseases): Study management and site management with monitoring.

Mijdrecht, The Netherlands

- Phase IV clinical studies (Psychiatry, Infectious diseases): Project management.- Medical Marketing tasks for antidepressant product.

Mijdrecht, The Neherlands

- Phase IV clinical studies (Psychiatry, Dermatology): Monitoring and site management.- Development of a filing system for Phase IV trials.- System administrator of software applications for the department.

Rotterdam, The Netherlands

Clinical study; the effect of magnesium supplementation in women with mild hypertension: Analyze the results and write the study report.

Rotterdam, The Netherlands

Erasmus Rotterdam Gezondheid en Ouderen study: Analyze the relation between the IMT of the carotis and haemostatic factors.

Master Of Science (Msc), Health Science - Biological Health Science, Msc

High School, Vwo