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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