Clinical Scientist, Medical Monitoring – Oncology, Multi-Indication

Job Description:

• 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
• Perform regular and ad-hoc medical review of data listings and data visualizations
• Analyze data to identify risks and patterns/trends and support documentation of medical reviews
• 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 the primary interface among internal teams, customers, and vendors for medical data and eligibility review
• Collaborate with study teams to identify data integrity and subject safety risks
• Escalate project concerns, at-risk deliverables, and out-of-scope tasks to project leads
• Attend Trusted Process meetings and participate in internal and external audits
• Adhere to applicable data privacy, ICH, GCP, company, customer, and project requirements

Requirements:

• Knowledge of ongoing protocol designs and disease-related terminology and pathology
• Adherence to data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs)
• Adherence to enterprise and customer policies, standard operating procedures, work instructions, and project plans
• Equivalent experience, skills, and/or education will also be considered
• Ability to work with medical data review, eligibility review, data listings, and data visualization
• Ability to author medical data queries and review query responses
• Ability to collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams

Benefits:

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Company car or car allowance
• Medical, Dental and Vision health benefits
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO)
• Sick time
• Reasonable accommodations when appropriate