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.
Come join a fantastic Team! The Clinical Study Manager is responsible for managing and conducting a program of clinical studies and related clinical activities, to support product registrations and market access. The Clinical Study Manager works frequently with new product development core teams, marketing, clinical strategy, clinical compliance, statistics and data management staff, and regulatory professionals. The job holder reviews and supervises the work of CROs and other staff/vendors involved in the clinical research program as required.
The Clinical Study Manager is responsible of creating and submitting clinical study applications to competent authorities, ethics committees and other interested parties as applicable. The incumbent of this position ensures compliance of LMS with applicable governmental regulatory policies and procedures as well as applicable corporate and divisional policies and procedures, as related to clinical investigations. The associate will be expected to maintain current knowledge of FDA, Health Canada, and European regulations, legislation, best practices, and guidelines related to clinical studies.YOUR RESPONSIBILITIES
YOUR RESPONSIBILITIES
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.
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.
Establish budgets and contracts for studies.
Ensures budgets and spends are tracked and kept to forecast.
YOUR PROFILE
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
Competitive Salary as well as relocation packages
Continuous training, support and focus on your personal development
Workplace Flexibility
Summer Hours
Desired qualifications express expectations for ideal/fully proficient candidates; equivalent experience will also be considered.
GET MORE INSIGHT
Learn more about what we do and who we are by watching our company video “We Are Leica”: https://www.youtube.com/watch?v=1zHmalqMXN4
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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.
Given the essential job duties of this position, the employee is required to be fully vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation and applicable law.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
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