Clinical Manager

À propos de cette offre

About the role:

Acrostak is a global leader in health technology, committed to improving hundreds of thousands of lives worldwide and striving to make the world healthier and more sustainable through optimized manufacturing and innovation.

We are looking for a Clinical Manager, which will help us build the clinical strategy as well as the clinical department. The Clinical Manager will be responsible for pre- and post-market activities for the assigned platform including clinical requirements guiding design input, pre-clinical testing, clinical input to regulatory submissions, market conditioning for new solutions, post-market evidence generation and KOL development. The individual will serve as a major pillar in building relationships with global KOLs and demonstrating the clinical value and benefits of the solutions. The clinical manager will report directly to the CEO.

Key responsibilities:

• Develop and manage clinical project plan, timelines, and budgets end to end; clinical research, through pre-clinical evaluations, clinical trials and publications, to user guidelines and post-market evidence generation.
• Form and cultivate strong collaborative relationships with cross-functional partners in R&D, product, marketing, and regional teams
• Coordinate internal cross-functional teams, as well as external clinical research associates, data managers, and biostatisticians
• Oversee the execution of clinical studies, ensuring adherence to protocols and regulatory requirements
• Lead the clinical input and support for key regulatory submissions and processes: regulatory submission clinical input, clinical validations, CER, CDP, CEP and more
• Support marketing/commercial activities from the scientific/medical point of view: review and input to marketing collateral, develop white papers, active participation in scientific meetings and more
• Communicate project status to stakeholders and provide updates on milestones and deliverables
• Identify potential risks and implement mitigation strategies to ensure project success.
• Writing clinical research protocols in the interventional cardiology field.
• Interaction with FDA and management of related clinical projects.
• Leads studies execution in accordance with study protocols, Instructions for Use (IFU), US and OUS standards and guidelines, Good Clinical Practices (GCP), and Standard Operating Procedures (SOPs), as applicable.

Requirements:

• Bachelor's degree in life sciences or a related field; advanced degree preferred
• Minimum of 5 years of experience in clinical project management within the medical device or pharmaceutical industry.
• Swiss work permit / European citizenship is a must.
• Proven track record of managing multiple clinical trials simultaneously
• Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements.
• Excellent organizational and leadership skills, with the ability to work under pressure
• Effective communication skills, both written and verbal
• Experience with clinical trial management software and data analysis tools
• Fluent English (written and spoken)
• Travel (15%); Global