YOUR JOB DUTIES
- Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company’s research interest.
- Give insights into clinical data sets and evidence for our company’s products to internal stakeholders.
- Assess clinical study ideas and initiatives as well as act as process owner for the respective internal approval process.
- Identify scientific projects and data analysis (together with internal and external stakeholders) to address unmet and unanswered medical research questions of the scientific community.
- Keep record of clinical initiatives, grants and data collections in the field.
- Define data endpoints and sample sizes (together with clinical evaluation team and support of biostatistics) for data collections, studies and clinical initiatives.
- Author and review study synopses and clinical trial protocols, regulatory documents, and study-related publications for clinical initiatives and grants.
- Interpret and analyze clinical data for clinical evaluations and scientific projects, working closely with clinical evaluation team and biostatistics to ensure robust scientific conclusions.
- Support regulatory submissions, post market surveillance and scientific projects, by working on and presenting scientific evidence to internal and external stakeholders.
- Engage with Key Opinion Leaders (KOLs) and physicians who lead IITs (investigator initiated trials) and/or work on scientific projects, fostering strong scientific collaborations.
- Train the clinical team on clinical trends and news.
- Stay informed on evolving clinical trends, competitor data, and regulatory updates to refine our clinical strategies.