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