Principal Clinical Scientist

Position Summary:

The Principal Clinical Scientist, Clinical Science Analytics & Insights is responsible for & manages the operational clinical science function from study start up through database lock for assigned projects focused on the scientific & indication specific insights into data collection & data visualization outputs to support scientific, clinical-sense data cleaning as part of Precision’s cross-functional data review team. Serves as the subject matter expert in the application of clinical knowledge, guidelines & standards of care to the review of clinical trial data. Serves & contributes to project teams as the CSAI functional lead delivering within scope, time & cost.

Essential functions of the job include but are not limited to:

• 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.
• 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.
• Serve as an ambassador to promote Precision’s high quality & ethical image in accordance with the company Core Values
• May develop &/or review of SOPs.
• May develop &/or present departmental trainings.
• Contribute to & support company & CSAI process improvement initiatives.
• Performs other duties as assigned by management.

Qualifications:

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

Other Required:

• 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

Preferred:

• Medical related degree, RN, OCN, RPH, PharmD, etc.
• Database build experience
• On-site monitoring experience &/or data review experience
• Experience with data visualization software such as JReview
• Experience in solid & liquid tumors
• Experience in phase I, II & III studies
• Experience in global trials
  
  

Skills & Competencies:

• Demonstrates highly advanced knowledge in oncology & medical terminology with ability to apply knowledge to clinical trial data including the application of disease assessment criteria, standards of care, grading criteria, etc.
• Desire to continually learn & keep up to date on medical & oncology standards of care with the ability to self-research & educate.
• Working knowledge of FDA & ICH-GCP, relevant SOPs & regulatory guidance with a well-rounded knowledge of the entire clinical trial process & working understanding of clinical research functional departments
• High level of integrity from a professional & ethical perspective
• Ability to independently manage the CSAI operational function in a global, cross-functional environment with awareness of appropriate escalation.
• Excellent time management, negotiation, critical thinking, decision making, analytical &conflict management skills with the ability to strategically plan & apply effective risk management.
• Exhibits self-motivation with the ability to work remotely while independently lead, support & inspire excellence.
• Demonstrates ability to adjust to multiple demands & shifting priorities.
• Results oriented, accountable, motivated, cooperative, & flexible
• Ability to apply financial management skills at the functional area project level.
• Excellent presentation, verbal, & written communications skills