Vaccine Clinical Scientist: Data-Driven Medical Lead

Syneos Health/ inVentiv Health Commercial LLC; North Carolina; On-site; USD 100,000 - 160,000; Full time

Benefits offered by this job

a company car or car allowance

Health benefits (Medical, Dental and V

Job summary

Syneos Health is seeking a Clinical Scientist - Vaccine to join our medical and scientific team in North Carolina. You will collaborate with Medical Directors to develop medical plans, review data listings, and prepare Medical Review Summaries as needed.

The role emphasizes data integrity, compliance with ICH/GCP, and cross-functional collaboration within Clinical Operations and Drug Safety. Ideal candidates have strong data review skills, experience with medical data in trials, and the ability

Responsibilities

• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan).
• Performs regular and ad-hoc medical review of data listings and data visualization; analyzes the 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 the project specific milestones and timelines are met.
• Serves as primary interface between internal team, customers, and vendors in the areas of 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.
• Attends at 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, and GCPs, all enterprise policies, standard operating procedures, work instructions, and project plans.

Job description

Syneos Health is seeking a Clinical Scientist - Vaccine to join our medical and scientific team in North Carolina. You will collaborate with Medical Directors to develop medical plans, review data listings, and prepare Medical Review Summaries as needed.

The role emphasizes data integrity, compliance with ICH/GCP, and cross-functional collaboration within Clinical Operations and Drug Safety. Ideal candidates have strong data review skills, experience with medical data in trials, and the ability