(Senior) Clinical Project Manager (m/f/d) - temporary, 2 years
Croma-Pharma Ges. m.b.H
- Wien
- € 54.735 pro Jahr
- Befristet
- Vollzeit
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
- 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)
Digital Literacy, interest in IT-Systems and processes
Goal-orientation and a sense of purpose
Engagement and proactive thinking
Teamwork-skills and integration abilitiesWe offer
- Collective agreement for the chemical industry, 38 hours a week - the minimum gross salary according to the KV is EUR 54.735,38 for this position. The actual salary depends on the specific qualification and experience.
- Flexible working hours and up to 15 home office days per month
- 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
We are filling this position by ourselves - please no inquiries from headhunters and recruiters.Apply
Karriere.at