Dagmar Joos-Spreng

pharmacist

Breslauer Str. 34
D-69518 Abtsteinach

Phone: +49 6207 92 17 69
Fax: +49 6207 92 17 68
Mobile: +49 1578 84 84 396

joos.spreng@t-online.de

Experience

Familiar with clinical research processes since 1994, self employed since 2010. Currently working as freelancer in clinical research.

Professional experience

CLINICAL MONITORING

  • monitoring of international trials, phase I-, II- and III
  • site selection visits, initiation visits, monitoring visits, closure visits
  • indications: HIV, immunology, oncology (NSCLC, solid tumours, colorectal cancer, prostate cancer) vaccination, multiple sclerosis, angina pectoris, hypertension

QUALITY ASSURANCE

  • realization of accompanied site visits (> 100): audit preparation, training and coaching, review of reports, discussion of quality aspects, implementation of actions
  • therapeutic areas: oncology, pneumology, cardiovascular (acute coronary syndrome, hypercholesterolemia, diabetes), gastrology, alzheimer’s disease

PROJECT MANAGEMENT

  • planning and coordination of clinical phase-I, -III and -IV trials, medical devices
  • therapeutic area: immunology, CNS, cutaneous mastocytosis, psoriasis and pneumology, diabetes
  • study coordination, submission to ethic committees and regulatory authorities, responsibility for budget, site identification, pre study visits, internal qualityassurance, organisation of study team meetings, preparation of Investigator Site Files and Monitors Files, organisation of Study Master File, controlling of quality and efficiency

SOFTWARE

  • pCRF, WBDC (Oracle, RAVE, ClinPhone EDC System, InForm 4.6, DPS, Advance), CTMS (Impact, TrialWatch, InnTrax, CREDI, ClinAdmin), eDOC, eQuality
TRAINER
  • Training of CRAs, Project Leader and further clinical research staff
  • classroom trainings, presentations, training on the job, train the trainer
  • design, planning and development of concept, method and material for trainings
  • SOP, ICH-GCP-Guideline, AMG (German drug law), process specific training, monitoring skills

COACHING & LINE MANAGEMENT

  • line manager of a team of 9-12 CRAs (recruitment, training, process specific training, qualification, controlling of quality and efficiency, resource planning)
  • organization and holding regional meetings with CRAs
    coaching of CRAs
  • contribution to SOP development

Education / Qualification

  • since 1991 courses in: monitoring, ICH/GCP, AMG, EU directive, FDA inspections, quality assurance, project management, non-interventional trials, submission to ethic committees and regulatory authorities, statistics in clinical trials, several indications, recruiting of trial centres, reliability, sit in on department gyn. oncology as observer (hospitation), presentation skills, moderation skills, learn to teach, coaching, teambuilding, time- and selfmanagement, leadership development, feedback, pharma codex and others (for details see training record)
  • 11/1991 “Approbation” licence to practise as pharmacist
  • 5/1991 – 10/1991 practical training for pharmacists at „Rodenstein Apotheke“, Weinheim
  • 11/1990 – 4/1991 practical training for pharmacists at the laboratory for pharmaceutical research of Röhm Pharma GmbH, Weiterstadt
  • 03/1987 – 10/1990 studies of pharmacy in Frankfurt and Heidelberg

Freelancers

since 02/2010

Working for pharmaceutical and medical device industry as well as for CROs

LEAD CRA / Monitor

  • Feasibility, site selection, initiation, monitoring and closure of clinical trials, phase I-III and NIS
  • On-site and remote monitoring, data managementInternational Clinical Trial Manager

International Clinical Trial Manager

  • Project management activities
  • Protocol writing, production of documents, guidelines and eCRF, coordination of study report
  • Submission to EC and RA
  • Budget responsibility
  • Tracking of timelines
  • CRA qualification and resourcing
  • Cross-functional study team lead

Quality Assurance Manager

  • In-house Clinical Quality Manager (support of process audit, leading of team meetings, management of SOPs, templates & documents, project lead for development of new clinical trial management system, system trainer and administrator)
Tutor / Assessor
  • Site assessment visits with CRAs (training, performance review, documentation, escalation and discussion of findings)
  • Site preparation and training for audits and inspections
  • Review of visit reports

Trainer

  • IZKS Mainz (audits and inspections, role of CRA)
  • Contribution on preparation of monitoring training

Employments

AstraZeneca GmbH, Wedel

  • 09/2003 – 01/2010 Team Leader Monitoring
  • 05/2000 – 08/2003 CRA-Coach
  • 12/1999 – 03/2002 Regional Training Advisor
  • 12/1999 – 11/2007 monitoring of clinical trials (oncolgy)
  • 06/1998 – 09/1998 parental leave
  • 10/1996 – 11/1999 Fachreferentin/consultant:
    project leader, medical information officer, support of product marketing, training of sales representatives, medical and product specific presentations
Dr. Willmar Schwabe GmbH & Co., Karlsruhe
  • 04/1996 – 09/1996 Clinical Research Associate/internal monitoring
UPJOHN GmbH, Heppenheim
  • 06/1994 – 03/1996 Clinical Research Associate
  • 07/1992 – 05/1994 Trainee
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