Aktuelle Jobs im Zusammenhang mit Clinical Study Manager - Epalinges - Distalmotion SA
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Clinical Study Manager
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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
vor 4 Wochen
Epalinges, Waadt, Schweiz Distalmotion SA VollzeitAbout UsAt Distalmotion SA, we are committed 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 a diverse, international team,...
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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...
Clinical Study Manager
vor 2 Monaten
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 minimally invasive surgery.
We are a diverse, international team, headquartered in Lausanne, 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.
Are you looking for a new fulfilling challenge in a fast-growing medical device company? Join a team engaged in empowering robotic surgery, the new medical revolution.
About Clinical Study Manager:
The Clinical Study Manager is responsible for planning, coordinating, and executing clinical studies for our innovative medical device. The Clinical Study Manager will work closely 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. The ideal candidate should have a strong background in clinical research, excellent project management skills, and a passion for improving patient outcomes.
Duties and 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.Work Experience and Education requirements:
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.Knowledge, Skills & Abilities required:
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%).Benefits:
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.Distalmotion is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all qualified applicants and employees.
Distalmotion is a medical device company founded and headquartered in Lausanne, Switzerland. It was founded in 2012, as a spin-off from the Robotics Lab of the Swiss Federal Institute of Technology in Lausanne (EPFL). We are all united by the same goal - to empower more surgeons and hospitals to deliver the benefits of robotic surgery to more patients. We can only do this with the right people in our team. Apply now and be part of the mission to bring patients the best in minimally invasive care.
For further information visit: distalmotion.com and follow us on LinkedIn/Twitter: @Distalmotion.
