Ophthalmology Clinical Scientist - Data & Safety Lead

Syneos Health/ inVentiv Health Commercial LLC; Alaska; On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits to include Medical, D

Company match 401k

Employee Stock Purchase Plan

bonus/commissions eligibility

Flexible PTO and sick time

Job summary

Syneos Health is seeking a Clinical Scientist - Ophthalmology to collaborate with the Medical Director on medical plans and data reviews, ensuring accuracy and regulatory compliance.

You will work with study teams across Clinical Operations, Data Management, Drug Safety, and Pharmacovigilance, contributing to safety reviews and documentation. Emphasis on data-driven decisions and adherence to ICH/GCP guidelines.

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 (set-up and/or lead meetings as appropriate) 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 is seeking a Clinical Scientist - Ophthalmology to collaborate with the Medical Director on medical plans and data reviews, ensuring accuracy and regulatory compliance.

You will work with study teams across Clinical Operations, Data Management, Drug Safety, and Pharmacovigilance, contributing to safety reviews and documentation. Emphasis on data-driven decisions and adherence to ICH/GCP guidelines.