.Precision for Medicine are recruiting an experienced Principal Clinical Scientist to work remotely in Poland, Hungary, Serbia, Romania, Slovakia, Spain or the UK.
Position Summary: The Principal Clinical Scientist must have a strong working knowledge of medical and oncology standards applicable to clinical trials, preferably in the area of solid and liquid tumors.
The Principal Clinical Scientist manages the operational clinical science function from study start-up through database lock for assigned projects focused on scientific and indication-specific insights into data collection and 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, and standards of care to the review of clinical trial data.
A medical-related degree is 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, and cleaning.
Support and participate in the development and implementation of process flow for integrated, cross-functional data cleaning for interim and/or final study data deliverables between all applicable departments (e.G., data management, medical, safety, vendors, sponsor, etc.).
May be responsible for cross-functionally managing the overall data cleaning process internally to support interim and/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 and support to Data Management in the development and revision of eCRF specifications, edit checks, and completion guidelines and/or other study-specific documentation as applicable.
Provide indication-focused, scientific, clinical input and 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 and Financial Management on monthly invoicing and 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 and/or develop and maintain CSAI project-related plans, guidelines, and trackers.
Ensure applicable eTMF documentation related to CSAI is maintained as per study project plans and SOPs