Oncology Clinical Scientist: Medical Data & Strategy

Syneos Health/ inVentiv Health Commercial LLC; New York (NY); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health benefits

401k match

Stock Purchase Plan

Bonus eligibility

Job summary

Syneos Health in New York seeks a Clinical Scientist - Oncology to join the oncology clinical development team. The role collaborates with Medical Directors to design medical plans, performs data reviews, and supports safety reviews across study teams in a fast-paced biopharmaceutical environment.

The position emphasizes adherence to ICH/GCP guidelines, data integrity, and proactive communication with vendors and customers, contributing to timely milestone delivery and high-quality scientific

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.
• 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, and GCPs, all enterprise policies, standard operating procedures, work instructions, and project plans.

Job description

Syneos Health in New York seeks a Clinical Scientist - Oncology to join the oncology clinical development team. The role collaborates with Medical Directors to design medical plans, performs data reviews, and supports safety reviews across study teams in a fast-paced biopharmaceutical environment.

The position emphasizes adherence to ICH/GCP guidelines, data integrity, and proactive communication with vendors and customers, contributing to timely milestone delivery and high-quality scientific