Clinical and Scientific Affairs Project Lead
vor 4 Monaten
For over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we’re driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation of our success.
Leica Microsystems is one of the market leaders in the fields of microscopy, imaging, and analysis. We reveal the invisible and empower our customers to create a better and healthier world. Together with our customers, we transform scientific discovery. We empower surgeons to take well-informed decisions in life-changing procedures. We enable users to gain insights which help answer key questions concerning development and engineering. All of this is achieved with the combination of cutting-edge microscopes and AI-based image analysis.
Want to be part of a company whose products are part of cutting-edge research around the world? Join Leica Microsystems in our commitment for brilliant solutions and insight.
Leica Microsystems is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
The **Clinical and Scientific Affairs Project Lead **is responsible for driving, managing and executing scientific, medical and clinical studies, ensuring state of the art insights, assessments, and execution of relevant studies, in alignment with LMS Medical Strategy and research and development needs, while ensuring compliance with regulatory, statutory and legal requirements.
She/He has cross-functional responsibilities, which require cooperating with various departments such as Product Managers, Regulatory Affairs, R&D, Marketing, Compliance, Legal, Regional Commercial/Sales, Service, Operations/Manufacturing as well as other external partners or authorities.
**Your Responsibilities**:
- Selects and manages experts and study sites.
- Drives, manages and executes research, pre-clinical (animal) and/or clinical studies, including post-market clinical follow-up.
- Authors study plans and protocols, with appropriate statistic rationales and methods of assessment, in accordance with intended clinical benefits and performance (study design).
- Ensures operational aspects of the studies are being conducted in accordance with all relevant ethical and government standards, Good Clinical Practices or Good Laboratory Practices, and company's procedures.
- Ensures submissions to regulatory competent authorities and ethics committees/IRBs, as required.
- On-site driving and executing studies, as required, per specific project.
- Analyses and discusses data, and prepares study reports.
- Maintains a high level of professional expertise, staying abreast with scientific literature, product portfolio, and the competitive and healthcare environments.
- Supervises and reviews study data and documentation when collaborating with CROs.
- Drives process improvement initiatives which relate to the described responsibilities**.**
- Up to 50% travel.
**Our Expectations**:
- Degree in Medicine / Medical Engineering/ Pharmacy or other human/clinical/medical science.
- 3+ years’ experience as a Clinical Research Associate, Clinical Project Manager, Study Manager or other related professional role.
- Fundamental knowledge and good understanding of GCPs, clinical trial design, study development and project management.
- Experience in interpreting, preparing, writing, and presenting scientific data and information.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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