Clinical Scientist

• Work with the Medical Director to develop medical plans, including Medical Management, Medical Data Review, and Eligibility Review Plans
• Engage outside experts, consultants, and advisors to obtain medical/scientific input for medical plans
• Perform regular and ad-hoc medical review of data listings and visualizations
• Analyze data to identify risks, patterns, and trends; document medical reviews
• Identify and resolve medical data review issues
• Author medical data queries, review responses, and approve query closure with the Medical Director
• Assist with patient profile reviews, scientific review of study-level data, protocol deviation reviews, and Medical Review Summary reports
• Partner with Medical Directors for medical data review and safety review meetings, including slide preparation
• Manage project scope, objectives, deliverable quality, milestones, and timelines
• Serve as the primary interface among internal teams, customers, and vendors for medical data and eligibility review
• Collaborate with study teams to identify risks related to data integrity and subject safety
• Escalate project deliverable risks and out-of-scope tasks to project leads
• Attend and present at Trusted Process meetings and participate in internal and external audits
• Adhere to data privacy guidelines, ICH, GCPs, enterprise policies, standard operating procedures, work instructions, project plans, and customer procedures
• Manage a limited number of direct reports and participate in or conduct interviews

Clinical Scientist jobs in Alabama

Clinical/Medical Scientist – Oncology – Breast