Global Clinical Development Manager (m/f)

Bavaria  ‐ Onsite
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Description


We are looking for a
Global Clinical Development Manager (m/f)

Reference: -en
Start: asap
Duration: 12 MM++
Place: in Bavaria
Branch: Pharmazeutische Industrie

Your tasks:
  • Provide clinical research expertise to the development of overall strategy and objectives of the Clinical development plan and to the design conduct and reporting of clinical trials
  • Prepare and contribute to scientific documents (e.g. HA briefing books, investigator brochure, regulatory/safety annual reports and submission documents)
  • Present program/progress to development committee and other management bodies at headquarters
  • Represent the company as development expert to health authorities, expert advisors and key opinion leaders
  • Plan/update/control staff resources and clinical program budget
  • Ensure compliance with financial and operating procedures within program/projects/trials/budgets
  • Set up and lead the timely, high quality planning and execution of the clinical development programs
  • Ensure quality conduct of allocated programs by implementing adequate QC measures
  • Ensure adequate safety reporting, serve as Medical Expert to Clinical Trials Teams, international clinical teams and PV and clinical safety department


Your qualifications
  • Special training or experience in dermatology and/or rheumatology
  • Strong experience in clinical research and biopharma development
  • State of the art medical, scientific and clinical research knowledge within the assigned area
  • Proficiency in all specs of the drug development process and knowledge of advanced clinical trial design, statistics and pharmacokinetics
  • Proven ability to interpret, discuss and represent efficacy and safety data regarding the assigned area and to provide recommendations on project level
  • Profound knowledge of GCP and worldwide regulatory requirements in the assigned area



Skills:
- Clinical project manager


Keywords: Clinical Project Manager
Start date
ASAP
Duration
12 MM++
(extension possible)
From
Hays AG
Published at
18.09.2015
Contact person:
Kerstin Werner
Project ID:
987519
Contract type
Freelance
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