Stefanie Smit Email & Phone Number

Amsterdam, Nh, Nl

Utrecht, Nederland

Accountable and responsible for the delivery of selected and/or regional deliverables in regards to the planning, start-up, conduct and closure of a global clinical trial. Support in overall strategy and development of clinical operations by attending/leading task force initiatives within the department and/or as part of cross-departmental teams. Assist in the efficient planning, conducting and reporting of the trial. Ensure the trial is delivered within timelines in close collaboration with the CRO and according to quality standards defined by regulations, SOPs and ICH-GCP.Competencies:* Planning and Organization* Clinical Development/Trial Conduct* Problem Solving and Decision Making* Communication* Quality Mindset* Document Creation and Management

Utrecht, Nederland

Global support on operational aspects related to planning, start-up, conduct and closure of clinical trials with emphasis on trial oversight activities. Activities include for example the following: Participate in the Global Trial Management Team, Support and develop trial related documentation (oversight plan, monitoring plan, IMP manual etc.), Development of PI/ICF, Perform CRO oversight including oversight visits, Participate in audits and inspections, Ensure compliance with relevant regulations, Lead and participate in cross-functional working groups and projects.

Capelle Aan Den Ijssel, Zuid-Holland, Nederland

Serve as the Pfizer clinical studies point of contact for investigative sites in The Netherlands as well as accountability for safeguarding the quality and patient safety at the investigator site. Responsible for siteoversight and building and retaining relationships from site activation through the lifecycle of studies. This role is also accountable for identifying CRO performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place. Key responsibilities are:* Relationship building and management* Proactively providing local intelligence in collaboration with Medical Affairs colleagues* Accountable for study start-up, activation, and execution to plan* CRO and Study Management Interface* Process, Standards, and Oversight* Protocol Site Oversight* Site and Study Management Interface

Amsterdam Area, Netherlands

Responsible for monitoring at multiple sites across The Netherlands for studies in the following therapeutic areas: hematology, oncology, infectious disease.

Bennekom, The Netherlands

Responsible for monitoring and unblinded monitoring at multiple sites across The Netherlands for studies in the following therapeutic areas: infectious disease, cardiovascular disease, pulmonary disease, oncology

Amsterdam Area, Netherlands

Responsible for monitoring and co-monitoring at multiple sites across The Netherlands in large cardiovascular outcome studies

Amsterdam Area, Netherlands

CTA supporting CRAs

Amsterdam Area, Netherlands

"Vinculin Recruitment upon Leukocyte Diapedesis: the role of vinculin in the formation of docking structures as well as its role during junctional remodeling upon leukocyte passage. "

Amsterdam Area, Netherlands

Study of Literature during the course of six weeks on the subject: "Transendothelial Migration of Leukocytes".

"Inflammation and Cardiomyocyte Loss: Mechanisms and targets for therapy in myocardial infarction and viral myocarditis"

"Development of an improved gene deletion system for Lactococcus lactis"

Master Of Science (Msc), Cardiovascular Research

Bachelor Of Science (Bsc), Biomedical Sciences