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Summary

phd immunologist, experienced Leader with over 18 years of diverse Clinical research and Pharmaceutical Industry experience. last 16 years in positions with international responsibility while successfully managing international clinical studies and leading a multicultural team of clinical study managers based in various countries to provide strategic oversight and direction for the delivery of the clinical studies. experience includes leading large highly complex cross-functional improvement / transformational projects to improve the organisation’s overall efficiency & productivity and developing Training programs for the Clinical monitoring organisation. strong knowledge of Clinical Trial methodology. sensitive to different cultures, strong Communication and interpersonal skills. team Leader and team player establishing and fostering strong relationships across functions. strong ability to adapt and evolve in a changing and challenging environment.

Experiences

Current Experience

  • Associate Director, Continuous Improvement, Strategic Clinical Operations, R&D (Global Position)


    Since February 2013
    feb 2016 to present : global clinical Training department building the global "development University" (one of the big transformational programs) & Training liaison for the global site management & monitoring function of the clinical field operations organization • assessing the learning and on-boarding needs for the global site management & monitoring function • developing course material / Training programs together with subject matter experts to deliver effective Training • ensuring the Training solutions developed compliment the long-range Training needs and development Strategy of the site management & monitoring function. • overseeing the workflow management for design and development projects and ensuring delivery of the Training material per the associated timelines and budget. • monitoring and evaluating the effectiveness of the Training curriculum by creating and implementing measures to track outcomes feb 2013- feb 2016: transformation program office • led large highly complex cross-functional and cross-divisional transformational programs / projects to meet R&D’s world class clinical execution’s strategic objectives. interacted with senior management to co-ordinate, collaborate and manage strategic initiatives. • worked with Clinical operations senior leaders and partnered cross functionally with Business Process owners to assess and identify key projects / processes to increase overall organizational productivity. led several global process and productivity improvement projects to achieve the strategic goals of R&D’s Clinical operations. • oversight of the transformation project portfolio. project prioritisation, timeline setting, status tracking, dashboard status reporting. • Project Management: applied knowledge, skills and techniques to execute projects effectively and efficiently tie them to business goals. consulted and supported the various project leads to effectively manage their projects Feb 2016 to present : GLOBAL CLINICAL TRAINING DEPARTMENT Building the global "Development University" (one of the big transformational programs) & Training Liaison for the Global Site Management & Monitoring function of the Clinical Field Operations organization • Assessing the learning and on-boarding needs for the Global Site Management & Monitoring function • Developing course material / training programs together with subject matter experts to deliver effective training • Ensuring the training solutions developed compliment the long-range training needs and development strategy of the Site Management & Monitoring function. • Overseeing the workflow management for design and development projects and ensuring delivery of the training material per the associated timelines and budget. • Monitoring and evaluating the effectiveness of the training curriculum by creating and implementing measures to track outcomes Feb 2013- Feb 2016: TRANSFORMATION PROGRAM OFFICE • Led large highly complex cross-functional and cross-divisional Transformational Programs / Projects to meet R&D’s World Class Clinical Execution’s strategic objectives. Interacted with senior management to co-ordinate, collaborate and manage strategic initiatives. • Worked with Clinical Operations senior leaders and partnered cross functionally with business process owners to assess and identify key projects / processes to increase overall organizational productivity. Led several global process and productivity improvement projects to achieve the strategic goals of R&D’s Clinical Operations. • Oversight of the Transformation Project Portfolio. Project Prioritisation, timeline setting, status tracking, dashboard status reporting. • Project Management: Applied knowledge, skills and techniques to execute projects effectively and efficiently tie them to business goals. Consulted and supported the various project leads to effectively manage their projects

  • Associate Director Continuous Improvement, Strategic Clinical Operations, Dev Ops, R&D (HQs in US)


    Since February 2013

    feb 2016 to present : global clinical Training department                                (hqs: chicago, usa)

    building the global "development University" (one of the big transformational programs) & Training liaison for the global site management & monitoring function of the clinical field operations organization

    • assessing the learning and on-boarding needs for the global site management & monitoring function
    • developing course material / Training programs together with subject matter experts to deliver effective Training
    • ensuring the Training solutions developed compliment the long-range Training needs and development Strategy of the site management & monitoring function.
    • overseeing the workflow management for design and development projects and ensuring delivery of the Training material per the associated timelines and budget.
    • monitoring and evaluating the effectiveness of the Training curriculum by creating and implementing measures to track outcomes 

    feb 2013- feb 2016: transformation program office                                          (hqs: chicago, usa)

    • led large highly complex cross-functional and cross-divisional transformational programs / projects to meet r&d’s world class clinical execution’s strategic objectives. interacted with senior management to co-ordinate, collaborate and manage strategic initiatives.
    • worked with Clinical operations senior leaders and partnered cross functionally with Business Process owners to assess and identify key projects / processes to increase overall organizational productivity. led several global process and productivity improvement projects to achieve the strategic goals of r&d’s Clinical operations.
    • oversight of the transformation project portfolio. project prioritisation, timeline setting, status tracking, dashboard status reporting.
    • Project Management: applied knowledge, skills and techniques to execute projects effectively and efficiently tie them to business goals. consulted and supported the various project leads to effectively manage their projects

    Feb 2016 to present : Global Clinical Training Department                                (HQs: Chicago, USA)

    Building the global "Development University" (one of the big transformational programs) & Training Liaison for the Global Site Management & Monitoring function of the Clinical Field Operations organization

    • Assessing the learning and on-boarding needs for the Global Site Management & Monitoring function
    • Developing course material / training programs together with subject matter experts to deliver effective training
    • Ensuring the training solutions developed compliment the long-range training needs and development strategy of the Site Management & Monitoring function.
    • Overseeing the workflow management for design and development projects and ensuring delivery of the training material per the associated timelines and budget.
    • Monitoring and evaluating the effectiveness of the training curriculum by creating and implementing measures to track outcomes 

    Feb 2013- Feb 2016: Transformation Program Office                                          (HQs: Chicago, USA)

    • Led large highly complex cross-functional and cross-divisional Transformational Programs / Projects to meet R&D’s World Class Clinical Execution’s strategic objectives. Interacted with senior management to co-ordinate, collaborate and manage strategic initiatives.
    • Worked with Clinical Operations senior leaders and partnered cross functionally with business process owners to assess and identify key projects / processes to increase overall organizational productivity. Led several global process and productivity improvement projects to achieve the strategic goals of R&D’s Clinical Operations.
    • Oversight of the Transformation Project Portfolio. Project Prioritisation, timeline setting, status tracking, dashboard status reporting.
    • Project Management: Applied knowledge, skills and techniques to execute projects effectively and efficiently tie them to business goals. Consulted and supported the various project leads to effectively manage their projects

Past Experience

  • Associate Director, Clinical Study Operations, GPRD (Global Position, HQs:US)

    January 2013 --- February 2013
    same as below. abbvie was formed from a spinoff of abbott

  • Associate Director, Clinical Study Operations, GPRD (Global Position, HQs: GER & US)

    February 2008 --- December 2012
    personnel management: • direct Line Management of 10 international clinical study managers / leads of clinical study Operations based in 6 countries who managed multiple international clinical studies. provided oversight of clinical study execution across multiple Therapeutic Areas and geographic regions. Performance Management, including Coaching / mentoring of staff and Training needs assessment. operational management: • long-range resource Planning / modelling and Budgeting to forecast resource needs for assigned clinical studies. ensured Clinical trials were managed and conducted within the corporate timelines, budget and in accordance with the company’s standard operating procedures and national regulations. provided guidance on corrective action plans for identified issues. developed processes & tools to promote operational efficiency of the team. organisational development: • Change Management: provided strategic input and support to meet the organisation’s transformational objectives. contributed to several transformation Leadership meetings & implemented change. co-developed and implemented a globalisation Strategy to establish a global organization (merger of us and ex-us study operation functions). • continuous improvement: contributed to global improvement via driving several cross functional task forces and/or participating in these to increase quality, productivity and efficiency and reduce overall operating costs of the organisation

  • Clinical Study Manager, International Clinical Field Operations, R&D (International Position HQ:GER)

    July 2001 --- February 2008
    international clinical field operations (icfo), previously european Clinical operations (eco): clinical study managament and monitoring operations in europe, canada, south africa, australia • managed several international clinical studies (Phase II to iv) across several countries in europe, asia pacific, africa in various Therapeutic Areas within set deliverables, budget and Compliance requirements • local clinical Trainer, part time for 1,5 years: developed and delivered SOP Training sessions to local clinical teams • country operations, part time for 1,5 years: responsible for local country Clinical operations

  • Senior Clinical Research Associate / Study Lead, EVR, GPRD (European position, HQs in UK)

    September 2000 --- July 2001
    the europeam venture research (evr) function, part of the global Pharmaceutical Research and development (gprd) organisation, was the european office of international Clinical study managment. • managed four Phase II/iii anti-infective international trials • supervised CRO’s cras while co-monitoring sites with them and ensuring adherence of the CRO to abbott sops. • oversight of monitoring activities in greece and israel for the anti-infective trials.

  • Clinical Research Associate (CRA)

    January 1999 --- January 2000
    in house CRA: assisted with the study management of cardiovascular (Phase III) & rheumatoid arthritis (Phase II) studies and conducted site monitoring activities

  • Veterinary Clinical Manager

    January 1998 --- January 1999
    reviewed and validated Clinical research data of several Phase III cardiovascular and anti-infective studies using specific Data Management Software: clintrial, SQL, crams/qrms

  • Part Time Teaching (during my PhD research in Immunology)

    January 1994 --- January 1997
    • taught immunological & biochemical Research techniques to undergraduate and postgraduate students. assisted head of Lab in preparing and conducting Student tutorials • supervised and advised undergraduates for their final year scientific projects

Personality

Self Assessment :
Strategic thinkingCritical thinkingResponsibilityProactivityResult OrientedProblem solvingAdaptabilityFlexibilityApproachabilityCollaborationCommunicativeOrganizationAuthenticityTrustInterest in knowledgeAnalytical thinkingAttention to detailEfficiencyCoordination

Knowledge

Self Assessment :
International Project ManagementLeadershippeople managementTeam LeadershipTeamworkClinical DevelopmentOperations ManagementClinical operationsClinical trial managementClinical researchClinical trialsKnowledge of the drug development processPharmaceutical DevelopmentPharmaceutical IndustryPhases of clinical development (phase I to IV)Program ManagementProject ManagementProject Portfolio ManagementPresentation SkillsTrainingGood Clinical Practice (GCP)Standard Operating Procedure (SOP)Business Process ImprovementContinuous ImprovementImmunologyInfectious diseasesUnderstanding of regulatory guidelinesInformed Consent ProcessEnglish
LinkedIn Assessment :
Clinical trialsClinical researchCROClinical DevelopmentCTMSGCPClinical Study DesignClinical monitoringImmunologyPharmaceutical IndustryProject ManagementProcess improvementICH-GCPFDASOPGlobal OperationsMulti-Cultural Team LeadershipLine ManagementPeople DevelopmentTherapeutic AreasoncologyClinical Trial Management System (CTMS)Clinical trial managementPharmacovigilance

Skills and Expertise

Self Assessment :
Analytical skillsAnalyse growth / improvement potentialApprove monitoring reportsbudgeting of R&D activitiesAdjust processes Adjust processes and methodsAdvise on strategyCoach and provide guidance to clinical staff.Collaborate with medical teamCollaborate with project teamCommunicationContribute medical, clinical expertise and scientific advice to all allied departments in local affiliate in particular support to the local clinical development team for timely execution of studies conducted in the affiliate and to DRA in interactions with authorities.assess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Attend investigator meetingCreates a collaborative team environmentDevelop training materialsDirect co-workers to achieve resultEstablish professional relationships with partnersGuide staffIdentify and provide training to trial team and associated staffIdentify growth / improvement potentialLead teamsManage research projectsNetworkOral presentationOrganise meetingsPeople managementproject managementProvide trainingRead medical literature to maintain current awareness and knowledgeWork collaboratively with the other members of the clinical research team Work cross-functionallyWritten presentation

Education

  • PhD in Immunology from King's College London, Univ. of London, United Kingdom in 1997
  • Maitrise (MSc) in Biochemistry from Université Pierre et Marie Curie (Paris VI), France in 1993
  • in from Primary and Secondary Education in English and Greek at various schools in Ethiopia, USA, Greece in 0000

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
French
Professional Proficiency
Greek
Native

Work Preferences

  • Notice Period:
    6 weeks
  • Positions I am interested in:
    Associate Director Clinical Operations Clinical Director Europe Clinical Project Leader Medical Director Project Leader R&D Director Team Leader
  • Work From Home:
    Yes, 5 Days
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Greece

Others

Driving License
  • Yes

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