Strefa Klienta
Our client is a globally active producer of pharmaceuticals. The company has subsidiaries in more than 10 countries and distributes its products in more than 70 countries. Currently we are searching for a Global Head of Clinical Project Management (m/f) in corporate function located in Vienna.
What's on Offer
Competitive remuneration based on collective agreement (Kollektivvertrag für Angestellte der chemischen Industrie VG V)
Job Description
- Manage a team of clinical project managers and medical writers
- Be responsible for design, strategic planning and supervision of project progress and project controlling of the clinical trials (Phase I to IV) outsourced to clinical research organizations (CROs) on global scale
- Lead in study design, clinical development strategy, SOPs in accordance with ISO 14155, protocol writing and supervision of clinical trials (GMP, non GMP, in vitro, in vivo)
- Be responsible for budgeting, planning and compliance
- Report directly to the CTO and act as a sparring partner in order to develop and implement the overall product and clinical trial strategy and the integration of the department within the company
- Provide leadership and coordinate the team in order to ensure the department's efficiency
- Manage and develop relationships with CROs
- Review in-licensing opportunities to support international business development opportunities
- Execute audits at external partners and audit centres
- Manage interactions with global regulatory authorities and ethic commissions
The Successful Applicant
- Life Science or medical graduate (preferred PhD)
- Minimum of 10 years experience in clinical drug development / clinical project management either in a pharmaceutical organization or in a contract research organization (CRO)
- Minimum of 3 years of leadership experience
- Experience in design, implementation and management of clinical trials in all phases of the drug development
- In-depth knowledge of international standards and guidelines: GCP, GMP, GDP, GLP, ISO/EN, ICH, GHTF, MDD, FDA
- Experience in filing clinical studies at authorities on global scale
- Organized, hands-on, very good communicative skills, strategic thinker
- Fluent in English and willingness to learn German
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