Clinical Project Manager (m/w/d)

Farkas Kiss Endre legjobb állása Croma-Pharma Ges. m.b.H

info@cromapharma.com;complaint@croma.at;office@croma.at

Bewerbung fur Team Lead Life Cycle Management - Manufacturing Science & Validation Engineering (m/w/d)

Levél szövege

Lieber Croma-Pharma Ges. m.b.H!

Ich möchte mich bei Ihrem Unternehmen als Clinical Project Manager (m/w/d) bewerben. 
Ich bin ein Fullstack-Entwickler, bei dem ich meine 10-jährige Erfahrung mit verschiedenen Technologien einsetzen kann.

Ich habe meinen Lebenslauf an diese E-Mail angehängt.

Wir freuen uns darauf, von Ihnen zu hören!


Endre Farkas Kiss "Sodika"
Java and PHP Fullstack Developer, Nudist, Vlogger

https://www.linkedin.com/in/farkas-kiss-63bb9210a
https://sodika.org

Álláshirdetés szövege

Clinical Project Manager (m/w/d)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. Ihre AufgabenPlanning, 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 Ihr ProfilScientific 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) Wir bietenWe 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. Jetzt bewerben