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HistoSonics, Inc. · 1 week ago

Upstream Senior Clinical Program Manager

Minnesota, United States

Full-time

Hybrid

Senior Level, Lead/Staff

$140K/yr - $165K/yr

5+ years exp

HistoSonics, Inc. is a medical device company focused on advancing the science of histotripsy for non-invasive therapies. The Upstream Senior Clinical Program Manager will collaborate with various departments to design and manage clinical studies that fulfill regulatory requirements and support marketing claims.

Health CareMedicalMedical Device

No H1B

Responsibilities

Works with key stakeholders to design clinical studies that meet key business objectives which may include the following: Collect clinical safety and performance data to meet regulatory requirements in key regions Collect clinical data to meet post-market requirements (e.g., CPT code applications, marketing claims, etc.)

Works with key stakeholders to ensure appropriate data elements are captured during CRF development

Partners with R&D, Professional Education and Medical Affairs to aid in procedure development for new indications

Supports the planning and coordination of clinical advisory boards to guide research activities as needed

Assists the Regulatory Affairs and Quality Assurance teams in preparation for reporting and submissions

May assist in internal and external audits

Develops and maintains strong relationship with physician collaborators

Qualification

Medical device clinical studyFDA regulatory knowledgeEU regulatory knowledgeAnalytical skillsLeadership abilitiesPrioritization skillsMicrosoft Office proficiencyCommunication skillsProblem-solving skillsCollaboration skills