Principal Clinical Scientist

Precision for Medicine are recruiting an experienced Principal Clinical Scientist to work remotely in in Canada.

Position Summary:

The Principal Clinical Specialist must have a strong working knowledge of medical and oncology standards applicable to clinical trials, preferably in the are of solid and liquid tumors. Principal Clinical Scientist 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. Medical related degree required (RN, OCN, RPH, PharmD, etc.).

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-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 …