Head of Clinical Operations (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 Department and therefore looking for a/an Head of Clinical Operations.

 
Ihre Aufgaben
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

Ihr Profil
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)

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 75,000, - (full-time, 40h) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.