Remote Principal Clinical Scientist

Summary

Join Precision for Medicine as an experienced Principal Clinical Scientist to work remotely in the United States. The successful candidate will have a strong working knowledge of medical and oncology standards applicable to clinical trials, preferably in the area of solid and liquid tumors.

Requirements

• Minimum Required: 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
• Oncology therapeutic experience required, with ability to apply working knowledge (e.g., understanding of clinical and oncology standards of care and associated side effects, biomarkers, etc.) to data review
• Experience in trial phase I, II and III
• On-site monitoring experience and/or data review experience (previous experience as a Clinical Research Associate (CRA) or Study Coordinator or Research Nurse preferred)
• Experience with electronic data capture systems (EDC) and data visualization tools (such as JReview)
• Computer proficiency
• Professional use of the English language; both written & oral
• Working knowledge of FDA & ICH/GCP regulations and guidelines
• Ability to occasionally travel domestically & internationally including overnight stays

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-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-specific documentation as applicable
• Provide indication-focused, scientific, clinical input & support to Data Management in the conduct of EDC UAT supporting the CSAI function as applicable
• Collaborate to support cross-functional departmental communication including internal CSAI communication as applicable on data capture, review trends, EDC updates, CSAI Programming needs, etc
• Support the identification of study risks including the management to correct any CSAI study-specific deficiencies
• Support Project & Financial Management on monthly invoicing & variance management of the CSAI budget
• Collaborate with CSAI management to ensure that CSAI resource needs are adequately addressed due to scope of work changes
• 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
• Support &/or conduct holistic &/or aggregate scientific, clinical sense data review based on defined manual Clinical Data Review Guidelines using various programmed outputs including but not limited to Smart Patient Profiles™, Smart All-Patient-Data Workbook, listings, quality metrics &/or graphs
• Oversee &/or issue & resole queries in various EDC systems
• Review &/or provide routine status updates on CSAI data review findings & escalate issues as appropriate
• Manage &/or conduct the development & associated User Acceptance Testing (UAT) of CSAI programmed output(s)
• Provide study-specific training for CSAI Scientists, project teams &/or study sites based on review findings
• Participate in internal & external study-specific team meetings &/or presentations as applicable including facilitating CSAI meetings or topics
• May support study-specific data related committees &/or meetings (e.g., safety review committee)
• May conduct review of Table, Figure & Listings (TLFs) &/or clinical study reports (CSRs)
• May participate in the interview process of potential new CSAI candidates
• May participate in business development activities including proposal development & client presentations as applicable
• Performs other duties as assigned by management

Preferred Qualifications

• Medical related degree, RN, OCN, RPH, PharmD, etc
• Database build experience

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation