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ARTIDIS · 2 months ago

Clinical Study Manager

Houston, TX

Full-time

Onsite

Senior Level

5+ years exp

ARTIDIS AG is a clinical-stage health-tech start-up company focused on developing innovative medical devices for cancer diagnosis and treatment optimization. The Clinical Study Manager will oversee the planning, implementation, and maintenance of clinical studies globally, ensuring compliance with regulatory requirements and good clinical practices.

Health CareMedical Device

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

Qualification

Clinical study managementGCP guidelinesRegulatory complianceMedical device experienceStudy protocol developmentSelf-organizationCommunication skillsProblem-solvingTeam player

Required

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