Website AvaWomen Ava

The world’s first smart bracelet to precisely track your fertility, pregnancy and health – all while you sleep.

Responsibilities:
• Lead and manage large clinical trials (e.g. trial design, statistical analysis plan, clinical documentation, CRO
appraisal and selection, recruitment planning, monitoring, close out, etc.)
• Analysis and interpretation of complex real-world data
• Drive clinical development deliverables (e.g., CEP, CIP, CER etc.)
• Represent Ava globally in scientific events and conferences
• Synthesize scientific knowledge for internal and external use (e.g. marketing, regulatory filings, peerreviewed journals)
About you:
PhD or M.Sc. degree in life sciences, medicine or epidemiology and 2+ years’ work experience in the clinical or
medical field, more if you don’t hold a PhD
Relevant experience and skills
• Prior experience in study coordination and management of Phase III-IV clinical trials and in leading clinical
research projects in collaboration with CROs
• Experience in managing clinical data sets with tools such as EDC including ePRO and familiarity with clinical
trial software (e.g., CTMS, eTMF, IWRS)
• Good general statistical and quantitative understanding in the clinical or medical field
• Experience in writing clinical regulatory documentations and submissions to health authorities
• Track record of peer-reviewed publications in medical journals
• Experience in establishing clinical quality management systems (e.g., SOPs, FOs, WI writing) is an advantage
• Prior exposure to the medical devices or software as medical devices industry and to women’s health,
fertility or endocrinology is an asset
• Knowledge of local Swiss and German clinical trial regulation
• Fluency in German and English with proven writing skills (e.g., previous successful submission or papers)
• Swiss or EU/EFTA work permit

To apply for this job please visit www.avawomen.com.