Clinical Study Manager

**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 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 mínimally 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**:
**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 a