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Summary

Clinical research specialist/ international project lead with: - +15 years CRO, Medical Device, biotech and Pharmaceutical Industry experience - in depth knowledge of ich gcp & regulatory requirements - broad experience within clinical Phase I-iv trials - profound knowledge of Clinical Trial Planning, execution and Documentation - cross cultural awareness & experience with stakeholder and vendor management - quality-mindset & business understanding - Analytical Skills & process overview - pro-active Communication style - commitment and focus on delivery of 'quality on time'

Experiences

Current Experience

  • Sr. International Trial Manager


    Since May 2009
    passionate and proactive trial management lead taking pride in: - efficient stakeholder management, alignment of expectations and common goals - having a supportive and mentoring/ Coaching role towards the team - keeping the process overview, yet having a detail oriented approach - making it possible ensuring 'high quality' project deliveries within ambitious timelines i strongly believe that my contribution, commitment and responsibility makes a difference.... Passionate and Proactive Trial Management Lead taking pride in: - efficient stakeholder management, alignment of expectations and common goals - having a supportive and mentoring/ coaching role towards the team - keeping the process overview, yet having a detail oriented approach - making it possible ensuring 'high quality' project deliveries within ambitious timelines I strongly believe that my contribution, commitment and responsibility makes a difference....

Past Experience

  • CRA/Medical Writer (PM)

    June 2007 --- April 2009
    a broad variety of tasks are associated with this position: - Project Management responsibilities: Planning and co-ordination of study activities including CRO selection and CRO Communication ensuring the conduction of quality trials within defined timelines. - Medical writing responsibilities: contribution to review and development of essential clinical documents such as Clinical Development plan, invesitgator brochures, protocols, crfs, crf completion guidelines, Statistical Analysis plan and clinical study report etc. - internal Communication e.g. as coreteam Member - Communication with external vendors e.g. statisticians, gcp-Auditor Consultant, Pharmacovigilance Consultant

  • Clinical Trial Manager

    March 2006 --- May 2007
    please refer to job description of current job.

  • Senior Clinical Research Associate

    November 2000 --- February 2006
    was operationally involved in multinational Phase III-iv trials, primarily within Diabetes and Cardiovascular diseases. responsibilities have spanned from site-selection and initiation to monitoring and close-out. have been involved in Coaching and co-monitoring. emplyoment in two periods: nov 2000 - jul 2003 interrupted by leave, were family was stationed in oslo mar 2005 - feb 2006

Knowledge

LinkedIn Assessment :
Clinical DevelopmentPharmaceutical IndustryCROICH-GCPClinical trialsGCPSOPDiabetesPharmacovigilanceClinical researchProject ManagementStakeholder EngagementStakeholder ManagementBudget ManagementMedical DevicesPharmacokineticsMedical writingVendor ManagementCross-functional team leadershipprotocol developmentCross Cultural ManagementMulti-Cultural Team LeadershipTeamworkDrug DevelopmentProtocol

Education

  • Mini MBA in Leadership Development from Probana Business School in 2014
  • M.Sc.Pharm in Specialised within clinical pharmacy/ clinical pharmacology from Danmarks Farmaceutiske Universitet in 1994
  • M. Sc. Pharm in Chemistry from Tornbjerg Gymnasium in 1986

Area / Region

Denmark

Others

Driving License
  • No

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