Principal Upstream Clinical Program Manager

Clinical OperationsClinical OperationsFull TimeRemoteLeadTeam 51-200Since 2009H1B No SponsorCompany SiteLinkedIn

Location

Minnesota

Posted

39 days ago

Salary

$170K - $190K / year

Seniority

Lead

Bachelor Degree8 yrs expEnglish

Job Description

Principal Upstream Clinical Program Manager

HistoSonics, Inc.

• Provides strategic leadership for upstream clinical programs, partnering 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.) • Drives cross‑functional alignment on CRF and data strategy, ensuring collection of high‑quality, decision‑grade data that meets regulatory, scientific, and business needs. • 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

Job Requirements

  • Bachelor’s degree required. Science, medicine or similar discipline; advanced degree strongly preferred.
  • Minimum of 8-10 years of progressive medical device clinical study experience, a minimum of 3 years in neurology strongly preferred
  • Knowledge of, and experience with, the FDA and the EU regulatory environments, with experience supporting global clinical strategies preferred
  • Excellent written and verbal communication skills
  • Strong analytical, critical thinking, and problem-solving skills with the ability to interpret and analyze data
  • Demonstrated collaboration and leadership abilities
  • Ability to participate in high-level technological and clinical discussions
  • Ability to discuss complex technology in clear, discernible terms
  • Demonstrated ability to develop and maintain relationships, internally and externally.
  • Demonstrated ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills.
  • Demonstrated record of converting strategic plans to prioritized product, development, and/or operational objectives
  • Demonstrated ability to handle shifting priorities in a fast-paced environment while maintaining communication with team and manager
  • Proficient in Microsoft Office, Word, and Power Point

Benefits

  • health, dental, and vision insurance
  • life insurance
  • short-term and long-term disability insurance
  • 401(k)
  • paid time off

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