Oncology Clinical Scientist — Medical Data & Safety Lead

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

Benefits offered by this job

Company car or car allowance

Health benefits

401k match

Employee Stock Purchase Plan

Bonus eligibility

Flexible PTO

Job summary

Syneos Health, a leading biopharmaceutical solutions organization, is seeking a Clinical Scientist - Oncology to join our integrated clinical development team. You will collaborate with Medical Directors and study teams to translate data into medical strategy and ensure rigorous data review and regulatory compliance.

In this role, you will develop medical plans, review data listings, prepare Medical Review Summary reports, and coordinate input from external experts.

Responsibilities

• Work with Medical Director to develop medical plans and coordinate input from outside experts to prepare the medical plans.
• Perform regular and ad-hoc medical reviews of data listings and visualizations; analyze data to identify risks and patterns.
• Author medical data queries and review responses; approve query closures with the Medical Director.
• Assist Medical Director in patient profiles review and protocol deviation review; create Medical Review Summary reports as needed.
• Partner with Medical Directors for medical data review meetings and safety review meetings, including slide preparation.
• Manage project scope, objectives and deliverables; serve as primary interface between internal team, customers and vendors in medical data review and eligibility review.
• Collaborate with study team members across Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management to identify data risks and safety concerns.
• Attend Trusted Process meetings and participate in internal and external audits.
• Acquire understanding of ongoing protocol designs and disease terminology; ensure familiarity with pathology terms.
• Adhere to data privacy guidelines, ICH, GCPs and enterprise policies, and project plans.

Job description

Syneos Health, a leading biopharmaceutical solutions organization, is seeking a Clinical Scientist - Oncology to join our integrated clinical development team. You will collaborate with Medical Directors and study teams to translate data into medical strategy and ensure rigorous data review and regulatory compliance.

In this role, you will develop medical plans, review data listings, prepare Medical Review Summary reports, and coordinate input from external experts.