(Senior) Clinical Project Manager (m/f/d)

Job title:

(Senior) Clinical Project Manager (m/f/d)

Company

Moglichkeiten Arbeitgeber

Job description

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.Ihre Aufgaben

• 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

Ihr Profil

• 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)

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

• 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.

Expected salary

Location

Kärnten

Job date

Fri, 11 Jul 2025 05:56:27 GMT

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