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Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
ID: 102444

Senior Clinical Trial Manager

  • Pharma & Biotech
  • Asap
  • Phases I – IV, Oncology, Dermatology, Cardiology
  • K-Recruiting GmbH
Ansprechpartner:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

Overview

Availability
Asap, full-time, onsite & remote
Qualification
Master of Science in Pedagogy
Language Skills
Czech (native), English (business fluent)
Relevant Expertise
Clinical Trials, Study Start Up, Contracting and Budgeting, Senior Clinical Research Associate, Good Clinical Practice, Risk Based Monitoring, Site Prepatation, Study Documentation, Submission to Ethic Committees & Authorities, Pharma

Key-Facts

  • Successfully completed various controlling projects

  • Over 10 years’ of professional experience as a Clinical Research Professional

  • Experience with the Phases I – IV in different therapeutic areas (Oncology, Dermatology, Cardiology, etc.)

  • Successfully placed as a Senior Clinical Operations Manager via K-Recruiting

  • Very experienced in solving problems and finding solutions tailored to individual requirement

Extract from previous activities

Biopharmaceutical Company, United States

Senior Clinical Trial Manager

  • Responsible for the management and oversight of clinical trials from start up, site and country identification, feasibility process oversight, conduct and reporting including timelines, quality and budget

  • Leading and coordinating the management, planning and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines on the study level

  • Development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets

  • Respiratory, phase II – 72 sites, 200 subjects (1700 subjects, 480 sites globally)

Pharmaceutical Company, Germany (via K-Recruiting)

Senior Project Manager Country Operation

  • Responsible for the management and oversight of clinical trials, from start up, site and country identification, feasibility process oversight through CSR including, management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines

  • Development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budget, monitoring oversight of site-level activities related to ongoing and planned trials, management of third-party vendors for clinical services, management of project timelines and deliverables

  • Rare diseases, phase II, III – Wilson disease, Myasthenia Gravis, PHN, Amyloidosis, Dermatomyositis, Geographic atrophy

Pharmaceutical Company, Switzerland

Senior Clinical Project Manager

  • Responsible for the management and oversight of clinical trials, management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines

  • Development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, monitoring oversight of site-level activities related to ongoing and planned trials

  • Infection disease / Covid- 19 study – 12 sites, 20 subjects

  • Gastroenterology – phase IIb – 9 sites, 45 subjects