Clinical Study Manager

Duties and Responsibilities

• Design, planning, implementation, overall direction, and management of clinical studies for medical devices.
• Management of all aspects of clinical studies, planning, execution, and close out, including oversight and day-to-day management.
• Ensuring that the Clinical Operations Team and external partner(s) receive study-specific training (identification of site staff training needs, support the development of training material, and delivery of training).
• Initiation, coordination, and responsibility for study protocol development and development of other operational documents as well as any updates/amendments to those documents according to regulatory and GCP requirements.
• Management of resources and timelines associated with all study start-up, implementation, conduct, and close-out activities.
• Ensuring the proper setup and maintenance of the sponsor file, including periodic reviews.
• Ensuring that investigational products and other study supplies are distributed and tracked and that sites at all times have required products for the performance of the study.
• Oversight of the study subject enrolment and clinical monitoring activities at study sites. Monitoring study progress to assure compliance with protocol requirements, QMS, and regulatory requirements as well as GCP of study sites.
• Identification and resolution of issues that may impact the conduct of the study or the necessary quality, timeline, or budget objectives.
• Accurate tracking of key study activities and maintenance study metrics for routine reporting.
• Ensuring that payments to sites and other vendors are tracked and performed according to the agreement.
• Ensuring that safety documentation and reporting are managed according to protocol, applicable processes of the QMS and regulatory, as well as local requirements.
• Conducting remote data monitoring and on-site visits (site initiation and training, monitoring, and close-out) following national regulations, GCP, and quality standard operating procedures as set out in the QMS.
• Having oversight and acting as contact with study sites and ensuring that all relevant communication is filed appropriately.
• Ensuring that sponsor and site file(s) are up-to-date and completed prior to archiving.
• Perform site audits, including source document review, as applicable.
• Plan and conduct internal and external meetings with study stakeholders (e.g., Investigator meetings).
• Being comfortable with measurement procedures of the ARTIDIS Medical Device.

Qualifications

• Degree in a scientific discipline or related field, or an equivalent combination of education and work experience.
• Minimum 5 years of medical device clinical study management experience in a leading position.
• Experience of the entire scope of medical device clinical studies, from drafting study proposals, preparation of study-specific documents, preparation and submissions to regulatory authorities and ethic committees/institution review boards, study initiation, study conduct, and study close-out.
• Advanced hands-on experience with guidelines related to GCP and applicability for medical devices and regulatory environment.
• Hands-on experience with regulatory guidelines and regulations and applicable GCP standards for medical devices.
• Excellent oral and written communication skills in English.
• Independent mindset, ability to self-organize and take ownership of assigned duties.
• Team player with a pragmatic approach and creative problem-solving capabilities.
• Thriving in a dynamic start-up environment, displaying a high level of flexibility, adaptability, and a hands-on mentality.
• Characterized by integrity, loyalty, discretion, and reliability.