Cardiovascular Clinical Scientist - Medical Data & Insights

Syneos Health/ inVentiv Health Commercial LLC; Phoenix (AZ); On-site; USD 110,000 - 160,000; Full time

Job summary

Syneos Health is seeking a Clinical Scientist - Cardiovascular to collaborate with Medical Directors in developing medical plans and leading data reviews across studies. The role involves interacting with external experts, validating data trends, and contributing to medical reviews and safety discussions.

You'll participate in cross-functional teams, manage project scope and timelines, and ensure adherence to ICH/GCP guidelines while supporting continuous improvement in trial design and data

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 the acquisition of necessary medical/scientific input to prepare the respective medical plans.
• Performs regular and ad-hoc medical review of data listings and data visualization as needed; 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. 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 of ongoing protocol designs and disease terminology and pathology.
• Adheres to data privacy guidelines, ICH, and GCPs, and to enterprise policies and SOPs.

Job description

Syneos Health is seeking a Clinical Scientist - Cardiovascular to collaborate with Medical Directors in developing medical plans and leading data reviews across studies. The role involves interacting with external experts, validating data trends, and contributing to medical reviews and safety discussions.

You'll participate in cross-functional teams, manage project scope and timelines, and ensure adherence to ICH/GCP guidelines while supporting continuous improvement in trial design and data