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Senior) Clinical Project Manager
vor 2 Wochen
CROMA-PHARMA is an internationally active 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.
At Croma-Pharma, we are committed to developing and marketing innovative products that help our customers improve their well-being. Join us and grow with us.
Your future job
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
Your qualifications and skills
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)
Your asset
Experience in the field of (medical) devices
Digital Literacy, interest in IT-Systems and processes
Goal-orientation and a sense of purpose
Engagement and proactive thinking
Teamwork-skills and integration abilities
We offer
Collective agreement for the chemical industry, 38 hours a week - the minimum gross salary according to the KV is EUR 59.781,96 for this position. The actual salary depends on the specific qualification and experience.
Flexible working hours and home office
Good public transport connections and free parking spaces
Croma restaurant with meal allowance and in-house fitness center
Pension and health care (company doctor and employee assistance programs)
Professional development
Our HR recruiting team will get in touch with you immediately.´
We are filling this position by ourselves - please no inquiries from headhunters and recruiters.
