Clinical Scientist (Medical Monitoring) - Oncology (Multi - Indication)

Overview

Clinical Scientist (Medical Monitoring) supporting oncology studies across multiple indications, working with the Medical Director on medical data review and eligibility review.

What you'll do

• Work with the Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan), engaging outside experts, consultants or advisors as needed to obtain medical and scientific input.
• Perform regular and ad-hoc medical review of data listings and data visualization; analyze data to identify risks and data patterns or trends and support documentation of medical reviews.
• Author medical data queries, review query responses, and approve query closure in association with the Medical Director.
• Assist the Medical Director with patient profile review, scientific review of other study-level data, protocol deviation review, and creation of Medical Review Summary reports as needed.
• Partner with Medical Directors on medical data review meetings and safety review meetings, including slide preparation as needed.
• Manage project scope of work, objectives and quality of deliverables to meet project milestones and timelines; serve as primary interface between internal team, customers and vendors for medical data review and eligibility review.
• Collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management to identify risks related to data integrity and subject safety, and escalate at-risk deliverables and out-of-scope tasks to project leads in a timely manner.
• Attend Trusted Process meetings and may participate in internal and external audits.
• Acquire a basic understanding of ongoing protocol designs, disease-related terminology and pathology.
• Adhere to data privacy guidelines, ICH and Good Clinical Practices (GCP), enterprise policies, standard operating procedures, work instructions, project plans, and customer policies as required.

Details

• Location: USA, remote.
• This posting is for a possible upcoming opportunity rather than a live role; expressing interest adds you to the talent pipeline.