Clinical Scientist

• Work with the Medical Director to develop Medical Management, Medical Data Review, and Eligibility Review Plans
• Engage outside experts, consultants, and advisors to coordinate medical/scientific input for medical plans
• Perform regular and ad-hoc medical review of data listings and data visualization
• Analyze data to identify risks and data patterns/trends and 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 review, and Medical Review Summary reports
• Partner with Medical Directors on medical data review and safety review meetings, including slide preparation
• Manage project scope, objectives, deliverable quality, milestones, and timelines
• Serve as primary interface between internal teams, customers, and vendors for medical data review and eligibility review
• Collaborate with study team members to identify risks related to data integrity and subject safety
• Escalate study concerns, at-risk deliverables, 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, SOPs, work instructions, and project plans
• Manage a limited number of direct reports and participate in or conduct interviews

Clinical/Medical Scientist – Oncology – GI

• Work with the Medical Director to develop medical plans
• Engage outside experts, consultants, and advisors to obtain medical/scientific input
• Perform regular and ad-hoc medical review of data listings and visualizations
• Analyze data, identify risks and trends, and document medical reviews
• Author medical data queries, review responses, and approve query closure with the Medical Director
• Assist with patient profile reviews, study-level scientific data reviews, protocol deviation reviews, and Medical Review Summary reports
• Partner with Medical Directors on medical data review and safety review meetings, including slide preparation
• Manage project scope, objectives, deliverable quality, milestones, and timelines
• Serve as primary interface among internal teams, customers, and vendors for medical data and eligibility review
• Collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management
• Identify and escalate data integrity, subject safety, deliverable, and scope concerns
• Attend and present at Trusted Process meetings and participate in internal and external audits
• Manage a limited number of direct reports and participate in or conduct interviews

Clinical Scientist jobs in New York

Clinical/Medical Scientist – Oncology – GI

Clinical/Medical Scientist – Oncology, Hematology