Clinical Scientist – Oncology

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Collaborates with the Medical Director to formulate medical plans, including the Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan.

• Engages with external experts, consultants, and advisors to gather essential medical and scientific insights for the preparation of the designated medical plans.

• Conducts routine and ad-hoc medical reviews of data listings and visualizations as required; analyzes data to detect risks and patterns/trends, supporting the documentation of medical reviews.

• Drafts medical data queries, reviews responses, and approves query closures in collaboration with the Medical Director.

• May assist the Medical Director in reviewing patient profiles, conducting scientific assessments of other study-level data, examining protocol deviations, and creating the Medical Review Summary report as necessary.

• Collaborates with Medical Directors during medical data review and safety review meetings, including preparing slides as needed.

• Oversees the project scope, objectives, and deliverable quality to ensure adherence to specific project milestones and timelines.

• Acts as the primary liaison between the internal team, customers, and vendors regarding medical data and eligibility reviews.

• Works alongside 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, setting up or leading meetings as appropriate.

• Participates in Trusted Process meetings and may take part in internal and external audits.

• Develops a foundational understanding of ongoing protocol designs and terminology related to diseases and pathology.

• Complies with all data privacy regulations, International Committee on Harmonization (ICH) guidelines, and Good Clinical Practices (GCPs), along with enterprise policies, standard operating procedures, work instructions, and project plans.

• Follows customer policies and standard operating procedures as outlined in project plans.

⛳️ Requirements

• Collaborates with the Medical Director to develop medical plans, including the Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan.

• Engages with external experts, consultants, and advisors to coordinate the acquisition of necessary medical and scientific input for preparing the respective medical plans.

• Conducts regular and ad-hoc medical reviews of data listings and visualizations as needed; analyzes data to identify risks and trends, supporting the documentation of medical reviews.

• Authors medical data queries, reviews query responses, and approves query closures in collaboration with the Medical Director.

• May assist the Medical Director in reviewing patient profiles, conducting scientific reviews of additional study-level data, examining protocol deviations, and creating the Medical Review Summary report as required.

• Partners with Medical Directors for medical data review meetings and safety review meetings, including slide preparation when necessary.

• Manages the project scope of work, objectives, and quality of deliverables to ensure that specific project milestones and timelines are achieved.

• Serves as the primary point of contact between the internal team, customers, and vendors regarding medical data and eligibility reviews.

• Collaborates with study team members, including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management, to identify risks to data integrity and subject safety, organizing or leading meetings as appropriate.

• Attends Trusted Process meetings and may participate in internal and external audits.

• Gains a basic understanding of ongoing protocol designs and terminology related to diseases and pathology.

• Complies with all data privacy guidelines, International Committee on Harmonization (ICH) standards, and Good Clinical Practices (GCPs), in addition to all enterprise policies, standard operating procedures, work instructions, and project plans.

• Adheres to customer policies and standard operating procedures as necessary in project plans.

🏝️ Benefits

• Comprehensive health benefits including Medical, Dental, and Vision coverage.

• Company-matching 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions and bonuses based on both company and individual performance.

• Flexible paid time off (PTO) and sick leave.