• Job Description

  Req#: 13378BR
  Job Description
  
  Involved in the design, conduct, data management, and interpretation and reporting of clinical trials. Responsible for project planning, oversight, and routine communication with the study team. Ensures clinical studies are conducted to the highest ethical and safety standards in accordance with the protocol, good clinical practices, MicroVention Standard Operating Procedures, and all applicable regulatory requirements (e.g., FDA) and guidelines.
  
  1. Provide oversight to the conduct of clinical studies
  2. Contribute to the preparation of study documentation such as protocols, amendments, case report forms, investigational plans, Investigator's Manual, and study reports
  3. Collect and process regulatory documents and correspondence
  4. Prepare and ensure the accuracy of MicroVention studies posted on clinicaltrials.gov
  5. Provide leadership to individuals responsible for the conduct of clinical studies (e.g., Clinical Research Associates and Clinical Trial Coordinators)
  6. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
  7. Perform additional duties as assigned
  
  Qualifications
  
  1. Bachelor's degree in Life Sciences or related field
  2. Minimum of six (6) years of direct clinical research experience (preferably in the medical device industry), including a minimum of four (4) years of demonstrated experience in clinical research project management (preferably in the medical device industry in support of IDE studies)
  3. Minimum of one (1) year of leadership or supervisory responsibility
  4. Knowledge of clinical study management, terminology, and related GCP and regulatory requirements
  5. Familiarity with the logistics of clinical design and logistical elements such as study documentation development, site selection, budget development, IRB submission preparation, training, database/CRF development, contracts, informed consent, randomization, monitoring, statistical plans, and the tracking of study metrics
  6. Strong verbal and written communication skills
  7. Proficiency computer skills including MS Word, Excel, Access, PowerPoint, Outlook, Teams, etc.
  8. Domestic and International travel required (~30%)
  
  Desired Qualifications
  1. Experience in designing and implementing clinical trials and interpreting trial results, including an understanding of biostatistics and safety reporting
  2. Minimum of two (2) years of monitoring experience, preferably in the medical device industry
  3. IDE clinical experience is strongly preferred, including experience in conducting global studies
  4. An understanding of worldwide regulations governing the conduct of clinical studies
  5. Able to handle multiple tasks efficiently and consistently, meeting deadlines
  6. Detail-oriented
  7. Ability to maintain strict confidentiality
  
  EEO
  We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.
  
  Fair Chance Ordinance
  If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
  
  Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.
  
  Salary Range
  
  $116,706 - $145,882(Financial compensation packages may be higher/lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)

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