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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 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 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