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Clinical Project Manager
Confirmed live in the last 24 hours
San Jose, CA, USA • Remote
Experience Level
Desired Skills
  • Bachelor's level degree or licensed certified health care training or equivalent combination of education and experience
  • Excellent communication skills (both written and verbal), with ability to build effective relationships with study center staff and colleagues
  • Must have excellent computer skills and is able to work in Microsoft Office
  • Ability to travel as needed, up to 30%. May include conferences, professional associations, and customer visits (e.g., site qualification, initiation, training, and/or monitoring)
  • Serves as primary contact and resource for assigned clinical studies / projects. Ensures studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations and departmental SOPs
  • Provides comprehensive support of all operational aspects of assigned clinical studies, including the review and approval of protocols and study-related documents (e.g., Regulatory Binder, Study Plans, Case Report Forms, Informed Consent Templates)
  • Collaborates with cross-functional stakeholders from R&D, regulatory affairs, marketing, and with external investigators to develop clinical studies, objectives and study designs for clinical evidence generation
  • Works with research sites to facilitate the successful and timely conduct of clinical studies. Includes site selection, startup, support of enrollment, and study closure activities
  • Oversees the monitoring, implementation and corrective actions for study progress using available study management tools
  • Maintains up-to-date knowledge of published literature in relevant therapeutic areas including a broad awareness of dialysis issues
  • Provides input and review of the development of in-house operations SOPs, guidelines and systems
  • Demonstrates thorough knowledge of and can coach others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies
  • Fully supports the Quality Policy by building quality into all aspects of this roles work and by maintaining compliance to all quality requirements
Desired Qualifications
  • Minimum of 5 years of experience in conducting clinical studies
  • Minimum of 2 years of experience in project management and/or oversight of clinical studies
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Must be approachable, show respect for others, and work effectively with a diversity of personalities
  • Good organizational skills and ability to meet tight deadlines in an environment of competing priorities
Outset Medical

501-1,000 employees

Dialysis medial equipment manufacturer
Company Overview
Outset Medical is on a mission to transform the dialysis experience – one of the largest, most expensive, and stagnant areas of healthcare. The company is focused on creating change, driving widespread adoption of new technology, and delivering on the promise of an improved experience for patients and lower cost of care for healthcare providers.
  • Medical, dental, & vision
  • Life Insurance/AD&D
  • FSA & HSA
  • 401k
  • Parental leave
  • Pet insurance
  • Tuition reimbursement
  • PTO
  • Company events
Company Core Values
  • Farther
  • Faster
  • Together