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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....

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