International Project Leader Clinical Trials
Since January 2015
International Project Manager Clinical Trials Boehringer-Ingelheim AB (Indications: Head and Neck cancer and IPF) As project manager for international trials I mainly work on international level and fulfill the requirements of managing clinical trials or projects to ensure timely delivery of project required objectives and timelines. I have overall responsibility for all aspects of the trial as budget, managing countries participating in the trials, setting up contracts with vendors, keeping timelines and more..
Country Project Manager Clinical Trials
Since June 2005
(Indications: Diabetes, COPD, Lung cancer, ovarian cancer, Head and Neck cancer and IPF) Different positions withing clinical operations: • Clinical Research Manager (BI)– responsible for the overall conduct of the study on a local level (Sweden). • Co- International Clinical Research Manager (BI)– responsible for certain parts of a study on international level. • Nordic Clinical Research Manager (BI) - responsible for the overall conduct of the study on a Nordic level. • T-CRA Trial Clinical Research Associate (BI) - responsible for the CRA issues on an international level, f ex monitoring manual, essential documents that need to be in the investigator site file etc.
Clinical Research Associate (CRA)
Since March 2004
Clinical Research Associate
Study Coordinator, Project Leader, Event Manager
August 1999 --- February 2004
Work included studies both acute and prevention studies. I also managed three different registries and issued yearly reports. SITS Register is an international web-based registry where I was involved throughout the development phase as a project leader. I was also responsible for a major international conference (Stroke Update) .
January 1991 --- January 2003
AdaptabilityCharmCollaborationCommunicativeCoordinationCreative thinkingCritical thinkingCuriosityEfficiencyFlexibilityIndependenceInnovative thinkingInterest in knowledgeKindnessOptimismOrganizationPerspectiveProactivityProblem solvingResponsibilityResult OrientedService orientedSociabilityTrust
Skills and Expertise
Assure medical quality Build and manage the Trial Master File (TMF) Control data Create SOPs Develop clinical trial protocols Interact with nurses Interact with physicians Monitor a clinical study Report data Write papers Write protocols Use content management systemsAct as the main line of communication between the sponsor and the investigatorAdverse event reportingApprove monitoring reportsApprove patient informationApprove Label Master SheetArchive documentationArchive study documentsArchive trial documentation and correspondence.Assess adverse reactionsAssemble regulatory applicationsAssess site feasibilityAssess subject safetyassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assign activitiesAssist study siteAssist with proceduresAssist with site trainingWrite documentsWork with coordination and data management teamsWork under specific instructionsWork cross-functionallyWork collaboratively with the other members of the clinical research team Update Clinical Trials Management System (CTMS) Understand protocolsTrain StaffSupervise clinical monitorsStatistical analysisStorytellingSolve problemsSite managementSet up a clinical studySerious Adverse Event (SAE) ReconciliationSelect contractors Review vendor reportsReview vendor metricsReview monitoring reportsReview inclusion criteriaReview exclusion criteriaReview dataRetrieve study documents
Project leader in from IHM Business School in 2003
Registered Nurse in from Sophiahemmet högskola in 1987