After versatile experience of 20+ years in global pharmaceutical industry and R&D, my current responsibilities include:
- Strategic planning, protocol writing, and management of clinical trial projects (interventional, non-interventional, all phases, paediatric) in partnership with different CROs.
- Reporting of trial results including report writing as well as review & management of publications.
- Review & preparation of material needed for marketing authorization applications and market access support.
As a former Drug Safety Officer I have previous experience from pharmacovigilance for which I still carry keen interest. After graduation and additional courses in journalism I worked in Basel Switzerland (in Lead Finding Unit) Specialties: Clinical Research, Pharmacovigilance, Medical Affairs, Journalism
Medical Affairs Manager
Since October 2015
Manager, Clinical Research & Medical Affairs
January 2014 --- September 2015
Clinical Trial Specialist (CTS)
December 2004 --- January 2014
Clinical Research Associate (CRA)
January 2003 --- January 2004
Clinical Research Coordinator
January 1998 --- January 2003
January 2000 --- January 2001
Lead Finding Unit
January 1995 --- January 1997
January 1991 --- January 1992
Special work and practical training under University degree program (fluidized bed granulation manufacturing process data).
Phase I R&D Scientific writingAdverse Events (AE)BudgetingClinical Data ManagementClinical DevelopmentClinical operationsClinical researchClinical Study DesignClinical study reportsClinical trial budgetingClinical trial designClinical trial managementClinical Trial Management System (CTMS)Clinical trialsContract negotiationCRFCROCRF designCTMSData AnalysisData cleaningData ManagementDesigning case report formsDeveloping Clinical Trial ProtocolsDrug DevelopmentDrug AccountabilityDrug regulatory authoritiesDrug Safety and PharmacovigilanceeCRFeCTDEDCEfficacy trialsEMAEnglishEthics submission and approval processGood Clinical Practice (GCP)Good Publication Practice (GPP)Health EconomicsICH guidelinesIMPDInformed Consent DocumentsInformed Consent ProcessIVRSKnowledge of the drug development processMarketing Authorisation Application (MAA)Medical affairsMedical writingMicrosoft OfficeMicrosoft PowerpointMicrosoft WordMultilingualOphthalmologyPediatricsPharmaceutical ResearchPharmacovigilancePhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)Project ManagementProject PlanningProject CoordinationProtocolReport WritingSafety trialsScientific WritingSearch literature on clinical trialsSerious Adverse Event (SAE)Standard Operating Procedure (SOP)Study approvalsStudy outcomes and outcome measuresStudy protocolsWriting Study Procedures and SOPsCNS
Skills and Expertise
Analytical skills Create SOPs Design case record forms Develop clinical trial protocols Develop protocols Interpret data Monitor a clinical study Report data Search literature on clinical trials Write protocolsApprove monitoring reportsApprove patient informationAssemble regulatory applicationsAssess adverse reactionsbudgeting of R&D activitiesBuild trial master file (TMF)Calculate trial timelinesCapture data on source documentsClinical data collectionCoach and provide guidance to clinical staff.Collaborate with project teamConduct literature searchesConduct site initiationCoordinate projectsCreate clinical documentsCreate SOPsData validationDesign case record form (CRF)Design clinical trialDesign exclusion criteriaDesign inclusion criteriaDesign information leafletDesign post-marketing surveillance studyDesign protocolsDesign studiesDesign subject consent formDevelop clinical strategyDevelop protocolsDevelop study budgetDevelop study timelinesEstablish contractsEthics committee applicationInitiate clinical trials Interact with CROsInteract with ethics committeeInteract with KOLInteract with regulatory stakeholdersInteract with statisticiansInteract with pre-clinical scientistsInterpret dataInterpret research resultsInterpret scientific dataLead studiesLiaise with doctorsLiaise with doctors and other professionals throughout the studyManage clinical trial files/documentsManage research projectsManage study budgetManage trial master file (TMF)Manage vendor budgetsManuscript preparationManuscript preparation and reviewNegotiate budget Observe trends in dataParticipate in medical reviewPlanning clinical studiesPre-study procedures Prepare final reportPrepare investigator brochuresPrepare manuscriptPrepare regulatory documentsPrepare responses to health authority queriesPresent clinical resultsproject managementPublication of articlesR&DRead medical literature to maintain current awareness and knowledgeRegulatory documentationReport study conclusionsRespond to audit findingsReview dataReview monitoring reportsReview vendor metricsSearch literature on clinical trialsSelect contractors Select investigatorsSelect sitesSerious Adverse Event (SAE) ReconciliationSet up a clinical studySite managementSolve problemsStudy-related documentsSubmit regulatory applicationsTrain StaffWork cross-functionallyWrite documentsWrite final reportsWriting regulatory documents
M.Sc. in Pharmacy from Helsinki University in 1993