Head of Clinical Operations (f/m/d)

Job Overview

Head of Clinical Operations (f/m/d)

Referenz-Nr.: JN -112020-1545429

Ort: Lower Austria

Anstellungsart: Permanent

Firmenprofil

Our client is an internationally operating company in the pharmaceutical industry, with headquarters in Austria. We are therefore looking for a Head of Operations (m/f) to join as soon as possible.

Aufgabengebiet

  • 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 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 processes and implementation of agreed improvement steps

Anforderungsprofil

  • 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)

Vergütungspaket

  • Salary of EUR 75,000, – (full-time, 40h) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience
  • International working environment
  • Employee parking
  • Home Office
  • Employee canteen
  • Development opportunities

Kontakt

Wir freuen uns auf Ihre aussagekräftige Bewerbung unter Angabe Ihrer Gehaltsvorstellung und der Referenznummer JN -112020-1545429. Ihre Bewerbung wird an den zuständigen Berater weitergeleitet. Bitte beachten Sie: Um eine schnelle Bearbeitung Ihrer Bewerbung sicherzustellen, bitten wir ausschließlich um Online-Bewerbungen.

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