Aktuelle Jobs im Zusammenhang mit Clinical Study Manager - Epalinges, Waadt - Distalmotion SA
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Clinical Training Specialist
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Epalinges, Waadt, Schweiz Distalmotion SA VollzeitAbout the RoleWe are seeking a highly skilled Clinical Training Specialist to join our team at Distalmotion SA. As a Clinical Training Specialist, you will play a crucial role in onboarding and certifying new Clinical Specialists, training surgeons, nurses, and reprocessing technicians, and conducting refresher training sessions.Key...
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Clinical Training Specialist
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Clinical Training Specialist
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Epalinges, Waadt, Schweiz Distalmotion SA VollzeitClinical Training SpecialistAt Distalmotion, we strive to provide the benefits of robotic surgery to more surgeons, hospitals, and patients worldwide. Our vision is to establish a new standard of care, removing traditional barriers and complexities of robotics to ensure greater access to best-in-class minimally invasive surgery.We are a diverse,...
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Product Support Quality Assurance Specialist
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Epalinges, Waadt, Schweiz Distalmotion SA VollzeitAbout Distalmotion SADistalmotion SA is a leading medical device company that aims to deliver the benefits of robotic surgery to more surgeons, more hospitals, and more patients globally. Our vision is to establish a new standard of care, removing traditional barriers and complexities of robotics to ensure greater access to best-in-class minimally invasive...
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Product Support Quality Assurance Specialist
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Product Support Quality Assurance Specialist
vor 3 Wochen
Epalinges, Waadt, Schweiz Distalmotion SA VollzeitAbout Distalmotion SAWe are a fast-growing medical device company dedicated to delivering the benefits of robotic surgery to more surgeons, hospitals, and patients globally. Our vision is to establish a new standard of care, removing traditional barriers and complexities of robotics to ensure greater access to best-in-class minimally invasive surgery.We are...
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Product Support Quality Assurance Specialist
vor 3 Wochen
Epalinges, Waadt, Schweiz Distalmotion SA VollzeitAbout Distalmotion SAWe are a fast-growing medical device company dedicated to delivering the benefits of robotic surgery to more surgeons, hospitals, and patients globally. Our vision is to establish a new standard of care, removing traditional barriers and complexities of robotics to ensure greater access to best-in-class minimally invasive surgery.We are...
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Clinical Study Manager
vor 2 Monaten
Epalinges, Schweiz Distalmotion SA Vollzeit**About us** At Distalmotion, we aim to deliver the benefits of robotic surgery to more surgeons, more hospitals, and more patients globally. Our vision is to establish a new standard of care, removing traditional barriers and complexities of robotics to ensure greater access to best-in-class mínimally invasive surgery. We are a diverse, international...
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Clinical Study Manager
vor 2 Monaten
At Distalmotion SA, we strive to revolutionize the field of robotic surgery by delivering cutting-edge medical devices to surgeons and hospitals worldwide. Our mission is to establish a new standard of care, removing traditional barriers and complexities to ensure greater access to best-in-class minimally invasive surgery.
We are a dynamic, international team, headquartered in Switzerland, with a growing presence and footprint globally. With over 150 members, more than 25 nationalities, speaking over 15 languages, we are all united by the same goal — bringing patients the best in minimally invasive surgical care.
About the RoleThe Clinical Study Manager is a key member of our team, responsible for planning, coordinating, and executing clinical studies for our innovative medical device. This role requires close collaboration with cross-functional teams, including researchers, physicians, regulatory affairs professionals, and external vendors, to ensure that studies are conducted efficiently, ethically, and in compliance with applicable regulations and guidelines.
Key Responsibilities- Study Planning and Design:
- Collaborate with internal stakeholders to ensure alignment on study objectives, design, and execution strategies.
- Develop comprehensive study plans, protocols, informed consent documents, and other essential study-related documents in compliance with applicable regulations, guidelines, and standard operating procedures (SOPs).
- Conduct feasibility assessments to determine study site selection and patient recruitment strategies.
- Define study timelines in collaboration with internal and external stakeholders.
- Study Execution and Management:
- Oversee all aspects of study initiation, including site selection, contract negotiation, and study team training.
- Coordinate and participate in country-specific regulatory submissions to ethics committees and competent authorities.
- Monitor study progress, ensuring adherence to protocols, timelines, budget, and quality standards.
- Coordinate and manage study-related activities, including data collection, monitoring, and analysis working closely with CRAs, Data Management, and the statistical team.
- Identify, address, and resolve any issues or risks that arise during the study and may impact timelines, data quality, or study integrity, ensuring timely communication with relevant stakeholders.
- Maintain accurate and up-to-date study documentation and records.
- Ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company Standard Operating Procedures (SOPs).
- Manage study budgets and resources effectively, tracking expenditures and ensuring optimal utilization of available resources.
- Team Collaboration:
- Work closely with cross-functional teams, including researchers, physicians, statisticians, and regulatory affairs professionals, to ensure alignment and efficient execution of study plans.
- Collaborate with external vendors, such as contract research organizations (CROs), study sites, and laboratories, to ensure successful study implementation and data collection.
- Provide guidance and support to study team members, fostering a collaborative and high-performing work environment.
- Quality Assurance and Regulatory Compliance:
- Participate in the development and implementation of quality control measures to ensure data integrity and accuracy.
- Stay updated on relevant regulations, guidelines, and industry best practices related to clinical studies and medical device development.
- Ensure the timely and accurate completion of all study documentation and study-related activities.
- Bachelor's degree in a scientific, technical, or healthcare-related field.
- Minimum of 3 years of experience in clinical research (clinical trial management), preferably within the medical device industry.
- English (written & spoken), at least one additional European language desired.
- Solid track record in successfully executing clinical trials.
- Demonstrated expert knowledge and comprehensive understanding of clinical trial design, conduct, and regulatory requirements (e.g., GCP, ISO 14155, MDR).
- Demonstrated experience in managing multiple clinical studies simultaneously, from study startup to closeout, including experience in managing CROs.
- Excellent project management skills, including the ability to prioritize tasks, manage timelines, and adapt to changing project needs.
- Comfortable with a dynamic, fast-paced environment.
- Proficiency in using clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other study-related software.
- Excellent interpersonal, written/verbal communication & organizational skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
- Detail and results-oriented working style, ethical and conscientious mentality, team-oriented attitude.
- Ability to work independently and take ownership of study deliverables.
- Willing & able to travel internationally, as required (up to 25%).
- Opportunity to work in a fast-growing company active in one of the most promising fields of medicine.
- A dynamic atmosphere in an internationally minded environment.
- Permanent contract with 25 days of paid vacation.
- Benefit from one day to two days per week working remotely to boost flexibility.
- Attractive talent development programs and initiatives empowering employees to enhance their skills and fostering professional development growth.
- Mobility plan, competitive company pension plan, support for gym memberships.
- Regular team building events such as boot camps, skiing and much more.
