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 & ethic