WANTED: Clinical Trial Manager (Medical devices)

Adamant Health is revolutionizing the care of Parkinson’s disease by enabling data-driven disease management, supporting personalized treatment and improving patient outcomes. Our unique CE-marked data-analysis technology provides detailed and accurate symptom data, helping clinicians to make more informed treatment decisions for their patients. We currently have 16 employees in Finland working in hybrid mode with offices in Kuopio and Helsinki. Adamant Health’s service for healthcare service providers is a measurement and analysis service consisting of both medical and non-medical devices.

We are looking for a highly organized Clinical Trial Manager to coordinate and oversee the clinical investigation (post-market) of Adamant Health’s medical device, ensuring the trial is conducted efficiently, on time, and within the budget. This role involves collaborating with the clinical trial team at Adamant Health and the research sites (clinics) in Finland and Germany. In addition, collaborating with external stakeholders, e.g., for site monitoring or with authorities for the study approvals, notifications, and reporting, is required to ensure compliance with regulatory standards and uphold trial quality.

The ideal candidate has a structured way of working with the ability to manage multiple priorities effectively. A solution-oriented mindset, flexibility, and a client-focused way of working help to succeed in the work at a start-up company.

Responsibilities:

• Together with the Chief Scientist at Adamant Health, set the targets and milestones for the clinical trial project implementation.

• Organize regular study meetings within the company and be responsible for reporting on the trial progression.

• Coordinate collaboration with the clinical investigation sites.

• Follow up and ensure that the study sites are properly trained and that they are following the study protocol.

• Contribute to the trial-related documentation.

• Develop and implement study-specific clinical monitoring processes and documentation.

• Organize site visits and monitoring, ensuring compliance with clinical trial requirements.

• Collect, review, and verify clinical trial documentation for accuracy and completeness.

• Ensure compliance with relevant SOPs, regulations, and guidelines.

• Manage and oversee the clinical trial budget.

Requirements:

• Bachelor’s degree in nursing, health sciences, or another relevant field.

• Previous experience as a trial manager in clinical investigations, preferably of medical devices.

• Good understanding of the related standards (especially ISO 14155) and national and EU-based regulations (Laki lääketieteellisestä tutkimuksesta 488/1999, MDPG in Germany, and EU MDR 2017/745).

• Comprehensive understanding of the ethical principles and evaluation process and good clinical practice (GCP) guidelines. Valid GCP certificate.

• Practical experience with using medical devices and software.

• Excellent verbal and written communication skills in English.

• Proficiency in Microsoft Office-based and similar tools.

• Ability to work both independently and in a multidisciplinary team, prioritize tasks, and manage multiple projects simultaneously.

• Willingness to travel as required.

Considered as a plus:

• Previous experience with Electronic Data Capture (EDC) systems and electronic case report forms (eCRFs).

• Previous experience with study monitoring.

• Practical experience with neurological patients.

• Previous experience with the DMIDS platform in Germany.

• Good communication skills in Finnish and/or German.

• Knowledge of FDA regulations.

This full-time position based in Finland (hybrid, preferably in Kuopio or Helsinki region) offers an exciting opportunity to contribute to groundbreaking medical device research while working in a fast-paced, collaborative environment. We encourage you to apply if you are passionate about clinical trials and regulatory compliance!

Please send your application and CV as soon as possible, but at the latest by 7th April 2025 via LinkedIn. Please include your salary expectation and your first possible starting date.

This position will be filled as soon as a suitable applicant is found.