Ophthalmology Medical Scientist – Data & Safety Lead

Syneos Health/ inVentiv Health Commercial LLC; Utah; On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Health benefits to include Medical,.Dl

Company match 401k

Eligibility to participate in Employee

Stock Purchase Plan

Eligibility to earn commissions/bonus

Flexible paid time off (PTO)

Job summary

Syneos Health / inVentiv Health Commercial LLC seeks a Clinical Scientist specializing in Ophthalmology to collaborate with Medical Directors, develop comprehensive medical plans, and conduct data-driven medical reviews. The role emphasizes coordination with external experts, authoring data queries, and supporting safety and protocol reviews.

The position requires alignment with ICH/GCP guidelines, privacy standards, and cross-functional collaboration with Clinical Operations and

Responsibilities

• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan).
• Engages with outside experts/consultants/advisors to coordinate acquisition of necessary medical/scientific input to prepare respective medical plans.
• Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes data to identify risks and data patterns/trends and supports documentation of medical reviews.
• Authors medical data queries and reviews query responses, approves query closure in association with Medical Director.
• May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed.
• Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed.
• Manages project scope of work, objectives, and quality of deliverables to ensure project-specific milestones and timelines are met; serves as primary interface between internal team, customers, and vendors in medical data review and eligibility review.
• Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management to identify risks related to data integrity and subject safety; escalates ongoing and newly developed study concerns to project leads in a timely manner.
• Attends trusted process meetings and may participate in internal and external audits.
• Acquires basic understanding and knowledge of ongoing protocol designs and disease-related terminology and pathology.
• Adheres to all data privacy guidelines, ICH, GCPs, enterprise policies, SOPs, work instructions, and project plans; also adheres to customer policies and SOPs as required in project plans.

Job description

Syneos Health / inVentiv Health Commercial LLC seeks a Clinical Scientist specializing in Ophthalmology to collaborate with Medical Directors, develop comprehensive medical plans, and conduct data-driven medical reviews. The role emphasizes coordination with external experts, authoring data queries, and supporting safety and protocol reviews.

The position requires alignment with ICH/GCP guidelines, privacy standards, and cross-functional collaboration with Clinical Operations and