Principal Clinical Scientist

Remote, MexicoFull-TimePrincipal
Salary not disclosed
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Job Details

Languages
English language; both written and oral
Experience
Minimum of 8 years of clinical research experience or proven competencies for this position
Required Skills
LeadershipCustomer serviceMicrosoft OfficeAttention to detailOrganizational skillsInterpersonal skillsData visualization

Requirements

  • Bachelor’s degree or equivalent combination of education/experience in science or health-related discipline with proficiency in medical terminology
  • Minimum of 8 years of clinical research experience or proven competencies for this position
  • Minimum of 1 year of leadership experience
  • Experience with electronic data capture systems
  • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
  • Excellent communication & interpersonal skills to effectively interface with others in a team setting
  • Excellent organization skills, attention to detail & a customer service demeanor
  • Professional use of the English language; both written & oral
  • Ability to occasionally travel domestically & internationally including overnight stays
  • Medical related degree, RN, OCN, RPH, PharmD, etc. (Preferred)
  • Database build experience (Preferred)
  • On-site monitoring experience &/or data review experience (Preferred)
  • Experience with data visualization software such as JReview (Preferred)
  • Experience in solid & liquid tumors (Preferred)

Responsibilities

  • Serve as the functional lead implementing CSAI services per study scope of work (SOW) on assigned project team(s)
  • Serve as a resource for project teams regarding scientific related data capture, review & cleaning.
  • Support & participate in the development & implementation of process flow for integrated, cross[1]functional, data cleaning for interim &/or final study data deliverables between all applicable departments (e.g., data management, medical, safety, vendors, sponsor, etc.)
  • May be responsible to cross-functionally manage the overall data cleaning process internally to support interim &/or final data deliverables (e.g., tier cleaning process/timelines, etc.)
  • Manage Medical Monitor review of subject data.
  • Provide protocol review from a scientific operational perspective.
  • Provide indication-focused, scientific, clinical input & support to Data Management in the development & revision of eCRF specifications, edit checks & completion guidelines &/or other study[1]specific documentation as applicable.
  • Support Project & Financial Management on monthly invoicing & variance management of the CSAI budget
  • Oversee &/or develop & maintain CSAI project related plans, guidelines, & trackers
  • Ensure applicable eTMF documentation related to CSAI is maintained as per study project plans & SOPs.
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