Senior 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/ an Clinical Project Manager.

 
Ihre Aufgaben
Implementation and oversight of clinical trials in direct responsibilities
Preparation and planning of clinical studies
Project controlling (dates, cost, reporting, regular meetings, milestones)
Collaborating with and managing external partners (vendors, clinical research centers)
Planning, implementation, coordination and supervision of clinical tr
Organization and management of study relevant documents (from concept to archival)
Implementation audits from external partners and test centers
Communication with the competent authorities and ethics committees
Presentation of study results in the context of meetings
Authoring or co-authoring internal Croma communications (i.e. project updates)
Preparation of clinical submission documents for a regulatory audience, within a team environment and ensuring process, content, and submission/document planning expertise
Creation and maintenance of MSOPs, SOPs and forms and further training, including development of appropriate workflows as relevant to clinical activities
Conduct of internal trainings
Ensuring critical review and interpretation of clinical efficacy and safety data
Review and comment on documents in clinical program (e.g, protocols, IBs)
Active role in improvement of CROMA processes and implementation of agreed improvement steps

Ihr Profil
Scientific degree, preferred PhD in life sciences
Prior clinical project management experience
Demonstrated experience in in planning, monitoring, and conduct of clinical trials with medical devices and/or drugs/biologics
Knowledge of the necessary processes of submission/implementation/completion of clinical trials with authorities
Familiarity with relevant 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 bieten
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 salary of EUR 63,000, - (full-time, 40h) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.