Clinical and Scientific Affairs Project Lead

vor 7 Monaten

Heerbrugg, Schweiz Leica Microsystems Vollzeit

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.

We currently offer a **Clinical and Scientific Affairs Project Lead** position in a flexible location in the EU, preferably in Germany, UK, Netherlands. This is a hybrid role.

**Clinical and Scientific Affairs Project Lead (d/f/m)**

Come join a fantastic team As a Clinical and Scientific Affairs Project Lead**,** you will have 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**:

- Select and manage experts and study sites in order to drive, manage and execute research, pre-clinical (animal) and/or clinical studies, including post-market clinical follow-up.
- Author study plans and protocols, and reports, with appropriate literature searches, statistic rationales and methods of assessment, in accordance with intended clinical benefits and performance (study design).
- Ensure 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.
- Ensure submissions to regulatory competent authorities and ethics committees/IRBs, as required.
- Up to 50% travel.

**YOUR PROFILE**
- 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.

**WHAT WE OFFER**
- Work and collaboration in an exciting international environment
- A balance between support and autonomy to achieve your own goals in an international environment
- We support employees in their professional and personal development

At Leica Microsystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Microsystems can provide.

GET MORE INSIGHT

Are you interested to discover new opportunities in an innovative, team-oriented environment?

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful **Danaher Business System** tools and the stability of a tested organization.

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.

If you’ve ever wondered what’s within you, there’s no better time to find out.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, wor

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