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%).

More information and application