Clinical Research Manager

Interested candidates will hold a Bachelor’s degree in a medical or related field and have at least 5 years of Clinical Trial or Research experience in the medical device/biotech industry.  

*Local Bay Area Candidates Only*

Essential Duties and Responsibilities

  • Develop and implement clinical trials, and post-market studies effectively while aligning regulatory and business needs.
  • Collaborate with cross-functional teams, external clinical suppliers/vendors, and external key stakeholders to ensure effective planning and execution of clinical trials.
  • Managing Clinical Trial's from concept to publication with multi-center studies.
  • Ensure that specific clinical plans and study protocols are consistent with corporate strategy.
  • Oversight to ensure patient safety, risk management, and compliance to SOPs, Quality System, Good Clinical Practice and applicable regulations for all Clinical Research activities.
  • Collaborate with cross-functional teams and external resources to assure successful clinical strategy and study execution.
  • Communicate the Clinical Strategy to all levels in the company, including Senior Leadership Team, R&D, Regulatory and Marketing groups.
  • Serve as clinical department CAPA and Audit champion.
  • Manage Clinical Research participation in early product definition, planning, and product lifecycle management, including defining new markets and uses for the product platform.
  • Maintain knowledge of competitive technologies and applicable regulatory requirements.
  • Oversee Clinical Research review of training materials, external communications, and marketing collateral for current and future product lines.
  • Responsible for building, developing and leading the Clinical Research function.
  • Coordinate standardized resource assessment and allocation for all clinical activities.
  • Comply and interface with applicable FDA and international regulatory laws/standards and the company code of conduct.
  • Coordinate process improvement initiatives, task forces, and committees within Clinical Research and cross-functionally.
  • Develop clinical protocols, clinical reports, Medical Affairs Strategies, and Clinical Evaluation Reports as needed.
  • Reviews clinical documents for regulatory submissions (FDA, Competent authorities, Notified bodies, IRBs, CLIA, CMS, etc.) as needed.
  • May author and implement clinical departmental policies and procedures in order to maintain clinical compliance at sites and internally.
  • As the department grows and the budget is approved, recruit and retain talent.

 

Requirements of the Clinical Trial/Research Manager

  • Bachelor’s degree in a health, medical, clinical sciences or technical field (e.g. engineering, physiology, nursing, biomedical sciences)
  • Minimum 5 years of Clinical Trial/Research experience within the medical device/ biotech industry
  • Experience with metabolic and hemodynamic monitoring in the ICU setting (i.e., glucose, lactate, hemoglobin, oxygenation)
  • Experience with CLIA regulations desired
  • Has prior participation in product development and all facets of clinical study development and execution, with both US and international trials preferred
  • Ability to work in a small company environment with a hands-on/roll up your sleeves attitude