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 Department and therefore looking for a/an Head of Clinical Operations.
- Lead a group of motivated Clinical Project Managers in the area of medical devices and medicinal products
- Define and implement with HR an effective staff training plan, including supervision, and mentoring of managers and team leaderResource planning and recruitment to deliver on all company budget targets, maintaining a climate to attract, retain and motivate top quality personnel
- Motivate staff to meet or surpass contractual and/or internal delivery targets and KPIs
- Act as Clinical Program Lead in selected projects, including
- 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 of audits from external partners and clinical study sites
- Communication with the competent authorities and ethics committees
- Presentation of study results in the context of meetings
- Authoring or co-authoring of 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
- Track record of developing/growing operational capabilities and processes and implementing improvements
- Strong financial understanding, including experience of setting and managing departmental budgets and forecasts
- Scientific degree, preferred in life sciences
- 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
- 7 years + experience within a senior clinical operations role within the clinical trial domain preferably within the medical device area
- 5 years + demonstrated experience of line management and team leadership
- Familiarity with relevant norms, standards, codes of practice and guidelines (e.g. ISO 14155, ICH-GCP, FDA's Code of Federal Regulations,)
- Fluency in English required, German preferred (written and spoken)
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 75,000, - (full-time, 40h) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.