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HistoSonics, Inc. · 3 hours ago

Clinical Program Manager

United States

Full-time

Remote

Mid, Senior Level

5+ years exp

HistoSonics, Inc. is a medical device company focused on advancing the science of histotripsy for non-invasive tumor treatment. The Clinical Program Manager will develop and manage global clinical studies, ensuring compliance with regulatory requirements and overseeing all aspects of clinical trial management.

Health CareMedicalMedical Device

No H1B

Responsibilities

Responsible for the management of Clinical Trials from inception through Clinical Study Report (CSR) completion

Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements

Create and implement study-specific clinical monitoring tools and documents

Lead the identification, evaluation, selection, and oversight of clinical trial sites

Author and implement operational plans to ensure efficient study enrollment and monitoring activities at clinical sites

Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations

Responsible for implementation and oversight of Trial Master File for inspection readiness

Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates

Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents

Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports)

Provide study updates and reports, inclusive of study risks and issues

Lead internal and external meetings, including Investigator Meetings, conferences, events and study management meetings

Responsible for ongoing study data reviews and data cleaning activities

Provide oversight of study activities such as site initiation, data quality, interim monitoring and close out activities

Support the development of study training to investigators, site staff and internal staff

Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections

Other duties as assigned

Qualification

Clinical trial managementMedical device experienceFDA regulatory knowledgeEU regulatory knowledgeWritten communicationVerbal communicationTeam collaboration