CROMA-PHARMA is an internationally active, family-owned pharmaceutical Company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti-aging.
We are searching for applicants who want to make a sustainable contribution to our success as a family- run Austrian company.
We are expanding our Clinical Development department and therefore looking for a Clinical Project Manager.
- Planning, implementation, coordination and supervision of globally outsourced clinical trials
- Project controlling (dates, cost, reporting, regular meetings, milestones)
- Communication with the competent authorities and ethics committees
- Preparation and Review of clinical submission documents for a regulatory audience, within a team environment, ensuring process, content, and submission
- Organization and management of study relevant documents (from concept to archival)
- Collaborating with and managing external partners (vendors, clinical research centers)
- Implementation of audits from external vendors and study sites
- Critical review and interpretation of clinical efficacy and safety data
- Presentation of study results in the context of meetings
- Active role in improvement of CROMA processes and implementation of agreed improvement steps
- Creation and maintenance of SOPs, including development/improvement of appropriate workflows as relevant to clinical activities
- Scientific degree, preferred PhD in life Sciences
- Prior clinical project management experience (min. 5 years) or equivalent
- Demonstrated experience in planning, monitoring, and conduct of clinical trials with medical devices and/or medicinal products/biologics
- Knowledge of the processes of submission/implementation/completion of clinical trials with authorities
- Familiarity with relevant laws, norms, standards, codes of practice and guidelines (e.g. ISO 14155, ICH-GCP)
- Experience in writing/creating SOPs
- Fluency in English and German (written and spoken)
We offer a varied work in a rapidly expanding company with diverse development opportunities and company benefits, as well as flexible working hours and home office. If you want to become part of a dynamic team, we look forward to meeting you!
For this position, a minimum salary of EUR 49.804,58 - (full-time, 38h) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.