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