Clinical Study Manager
vor 2 Wochen
Leica Microsystems has helped shape the future of microscopy for over 170 years 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.
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 proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
The Clinical Study Manager will work closely with Global Clinical Affairs leadership to ensure efficient and effective start-up, conduct and close-out of clinical trials.
**Your Responsibilities**:
Conducts research in a clinical capacity across all research phases including design, execution, and analysis and ensures the quality and integrity of data and safe and proper management of study parameters.
Responsible for delivering clinical research projects to ensure all trials, within responsibility, are delivered against agreed project milestones, budget and to expected quality.
Responsible for development of all clinical documentation required for study execution.
Collaborates with Principal Investigator and other pertinent site members, taking direct responsibility for carrying out research/ development activities.
Ensures that research projects are conducted in compliance with federal regulations, institutional/departmental guidelines, and standards of Good Clinical Practice.
Provides timely and high-quality preparation of assigned clinical deliverables including internal progress reports (metrics, action plans), external reports to support regulatory submissions to the global regulatory agencies and clinical evidence intended for external audiences (e.g., abstracts, presentations, whitepapers, publications).
Supports the development and implementation of clinical research standards, to add value to the business and improve service levels.
Where appropriate, represents Global Clinical Affairs at relevant cross functional project meeting(s).
Responsible for ensuring that clinical study related activities are carried out in accordance with the appropriate Good Clinical Practice (GCP) guidelines ISO 14155 standard and the EU Medical Device Regulation.
**Our Expectations**:
BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience in Medical Device
Previous experience in creating, managing, and auditing clinical trial master files and investigator site binders
Knowledge of applicable clinical research regulatory requirements
Experience with Preclinical Studies is a plus
Travel up to 25%
Position can be remote as long as located near a major hub/airport
**What we offer**:
We offer flexible working time models
We offer employees a wide range of (virtual) training opportunities to grow their skills in a huge variety of fields languages, technology, time management, the Danaher Business System, etc.)
We enable independent work and empowerment within a committed, international team
Equal pay is a matter of course for us
LI-KS1
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.
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