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Summary

welcome to my profile! i am a Freelance Clinical Research Consultant working in the industry since 2006. i have a solid scientific background and founded my way to clinical research by obtaining my phd with a focus on Inflammation and Cell-cycle regulation, followed by a post-doctoral employment dedicated to basic research in the field of pharmacology. holding various positions with increasing responsibility throughout the years, i have gained experience in a multitude of aspects of clinical research. in summary i have experience as a local and international CRA as well as international Project Manager and CRA line manager. furthermore, i have also been driving different projects related to clinical research, for example the creation and improvement of sops and the adoption of risk based monitoring strategies. i worked on pharma- as well on Medical Device trials (Phase III-iv/pre- and post-marked) in germany, austria, switzerland and spain. my focus lies on: - site management and monitoring activities - study start-up (including for example icf creation; ec, ca and radiation authority Applications) - leadcra - Clinical operations management/CRA Line Management - clinical Process development - Project Management - Training i work home based from germany (hannover as main base; berlin as second base) and i am happy to support your projects to make them a great success. best regards! david

Experiences

Current Experience

  • Freelance Clinical Research Consultant / senior CRA


    Since February 2016
    Freelance Clinical Research Consultant with focus on: • site management and monitoring activities • study start-up (including for example icf creation; ec, ca and radiation authority Applications) • leadcra • Clinical operations management/CRA Line Management • clinical Process developmentProject ManagementTraining Freelance Clinical Research Consultant with focus on: • Site Management and Monitoring Activities • Study Start-Up (including for example ICF creation; EC, CA and radiation authority applications) • LeadCRA • Clinical Operations Management/CRA Line Management • Clinical Process Development • Project Management • Training

Past Experience

  • Manager Clinical Operations

    November 2013 --- January 2016
    • managing a changing group of multinational cras mainly in the emea region to ensure that clinicial Research at site level is conducted and reported in accordance with the Clinical investigational plan, SOP´s and applicable regulatory requirements and project timelines. • driving the effectiveness and improvement of site management and monitoring to ensure Compliance • resource Planning • developing and Coaching of direct reports • monitoring of daily work Operations • review of visit reports and conduction of co-visits to assess CRA performance • overseeing the dach region with regards to study activities; coordination of submission of new studies and study amendments as applicable. • support of rbm (risk based monitoring) implementation including creation of the related procedure and supporting tools

  • Group Leader EMEA External Operations

    September 2011 --- October 2013
    • same tasks as CRA (reduced number of sites) • overseeing a small group of cras with Line Management responsibilities (e.g. development of direct reports, monitor daily work Operations) and review of visit reports. • support of managers and senior manager of external Operations to meet objectives for all Clinical trials with regards to monitoring and data collection. • additional projects, e.g. for process improvement as assigned (eg. SOP revision/improvement)

  • Senior CRA/Lead CRA

    March 2011 --- August 2011
    • promotion to scra in march 2011

  • CRA II/LeadCRA for medical devices

    June 2009 --- February 2011
    • conduction of pre- and post market studies in the field of Interventional Cardiology • lead CRA (pre-marked; bio-resorbable Vascular drug eluting scaffold) • support of a number of investigational sites in germany, austria and switzerland (poland, czech republic and spain as Interim back-up) to conduct Clinical research field and ensure that the trial at the site level is conducted, recorded and reported in accordance with the clinical investigational plan, SOP’s/dop´s and applicable regulatory requirements. • complete site management responsibilites including management of site Compliance and enrollment. • preparation of ec submission packages including related documents and perform ec submission as applicable. support competent authority submissions as applicable; including submissions to “bundesamt für strahlenschutz” (bfs) • mentoring less-experienced staff • serve as a project dedicated lead CRA

  • CRA I and II for pharmaceutical products

    January 2006 --- May 2009
    • conduction of studies Phase III and iv, mainly in the indications oncology and Nephrology • as off august 2007 position as a CRA ii • lead CRA (multiple myeloma and renal Cell Cancer) • performed routine site visits, including pre-study, initiation, Interim, and closeout visits. visits to include monitoring of proper Informed Consent procedures, Compliance with science)" rel="nofollow">Protocol, gcp/ICH guidelines, and other applicable regulatory requirements, and assurance of good site performance. • managed assigned sites by regular contacts to ensure site Compliance, adequate enrollment, and understanding of study requirements. • supervision of a team of 5 cras as a leadcra. review of trip reports. ensured adherence to monitoring frequency and timelines. assistance in monthly study status report generation. served as a line of Communication with the sponsor and Project Management. Training of new team members. • check of trial master file documents for consistency and quality; assisted Project Management in coordination of audit preparations for trial master files. • reported to project team, client, and site personnel any findings noted at monitoring visits, accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. significant issues reported to appropriate personnel immediately.

Knowledge

LinkedIn Assessment :
Clinical trialsoncologyClinical researchClinical monitoringCTMSGCPICH-GCPEDCCardiologyPharmaceutical IndustryClinical Data ManagementNephrologyCRORegulatory submissionsEC Submissions (MPG)Risk Based Monitoringpeople managementPeople DevelopmentInformBfSDevice StudiesCRA TrainingCancerTherapeutic AreasProject ManagementMedical Devices

Education

  • PostDoc in Pharmacology from Medizinische Hochschule Hannover in 2005
  • PhD in Biochemistry/Molecular Biology from Medizinische Hochschule Hannover in 2004
  • Diploma in Biochemistry from University Hannover in 2000

Area / Region

Hannover, Germany

Others

Driving License
  • No

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