with more than 15 years of experience from Pharmaceutical companies and CRO:s (contract research organisation) in managing national and international Phase I to Phase IV Clinical trials, all the way from the feasibility and study start to the final clinical study report; including study outline, Planning, coordination, monitoring, management, performance, termination and reporting of the trials.
claes jagensjö has experience in clinical project leading in Clinical trials having an overall administrative responsibility to supervise, co-ordinate and lead study specific activities and to implement and conduct a clinical study in accordance with the company SOP´s, ich-gcp requirements and local regulations.
Regional Medical LiaisonJune 2005 --- December 2009
- responsible for Quality Assurance projects and the company’s contact person for academic study groups and isss in the oncology / haematology field. - Communication of complex scientific information and Research concepts to Healthcare decision makers. - conducting study feasibilities
Associate Development Operational ManagerJune 2005 --- January 2007
- responsible for the Clinical trials in the oncology / haematology field in the nordic countries, including having an overall responsibility to supervise, co-ordinate and lead study activities. - managing a team of 3 cras and 1 CRO liaison.
Busniess DeveloperApril 2003 --- June 2005
- responsible for Marketing in the nordic countries of the cros activities and customer relationship. - customer meetings, offer and contract writing. - Clinical trial management of Clinical trials including crf design, Data Management duties and coordination and management of study team, setting up study Documentation, also including SOP:s, and budget responsibility for Clinical trials.
Clinical Research ManagerMay 2001 --- April 2003
- Clinical trial management of clinical trial including Data Management duties and assisting in coordination of study team, setting up study Documentation, also including SOP:s, and budget responsibility for Clinical trials. - responsibility for study drug handling in the nordic countries for a study with more than 4000 patients. - responsibility for a genetic sub-study.
Senior Clinical Research Associate (CRA)April 2000 --- May 2001
- conducting of multicentre Clinical research studies in the nordic countries as Investigator recruitment; evaluates, initiates, monitors and closes out sites. - lead CRA in an european multinational study and responsible for 2 countries (poland and france).
Clinical Research Associate (CRA)January 1995 --- January 1995
Medical Sales Representative Gothenburg, SwedenFebruary 1992 --- January 1994
CollaborationCommunicativeCoordinationEfficiencyFlexibilityInterest in knowledgeOrientationProactivityProblem solvingResult OrientedService orientedTrust
Good Clinical Practice (GCP)A rising single dose tolerance studyActions and modes of action of drugs in the human speciesAllergy and immunologyAntibodiesBiomarkersBudget NegotiationCardiovascular diseasesClinical monitoringClinical trial audits and inspectionsClinical trial budgetingClinical trial managementClinical Trial Management System (CTMS)CRODiabetesHematologyMedical DevicesMicrosoft OfficeoncologyOutsourcingPhases of clinical development (phase I to IV)Project ManagementQuality Assurance (QA)Regulatory submissionsTrainingVaccines
Skills and Expertise
Create SOPs Develop clinical trial protocols Interact with nurses Interact with physicians Monitor a clinical study Search literature on clinical trialsAct as the main line of communication between the sponsor and the investigatorAdjust processes and methodsApprove monitoring reportsApprove patient informationApprove drug supply Approve Label Master SheetAssess site feasibilityAssist study siteAssure medical qualityAttend at steering committee meetingsAttend steering committeeCalculate timelines for conducting and completing the trialCoach
MSc Pharm in from Uppsala universitet in 1992