Clinical Scientist

About the role

The Clinical Scientist is responsible for the review, interpretation, and assessment of oncology clinical data specifically solid tumor data with key findings communicated to Clients and study team. The Clinical Scientist works closely with the Medical Monitor as appropriate. This role communicates and presents clinical trends and findings to the Study Team and Clients while working collaboratively to ensure high quality data, maintain the highest integrity of the clinical database and clinical study reports (e.g., CSR). The Clinical Scientist partners with Clients, subcontractors, and internal study team members to meet project timelines and expectations related to clinical data review.

Responsibilities

• Develop oncology clinical data review plans for assigned studies.
• Conduct ongoing oncology clinical data review and analysis of clinical data, (e.g., efficacy, safety related data components) utilizing listings, visual analytics, tables, figures, graphs, and EDC continually.
• Present key oncology data trends and findings to the Medical Monitor, Study Team, and Client.
• Collaborate with cross‑functional study team members to ensure protocol‑defined variables are collected and reported accurately.
• Track and analyze potential safety events in collaboration with Pharmacovigilance and Medical Monitoring.
• Contribute to discussions on potential study or strategy modifications based on clinical data review.
• Create data summary slides for Safety Review Committee Meetings, Data Review Meetings with support from Director.
• Query data as appropriate on EDC data as needed during Clinical review with timely follow up, and identification of potential protocol deviations.
• Partner with vendors and study team members to ensure accurate endpoint reporting.
• Serve as a point of contact for site staff and monitors for protocol and clinical inquiries.
• Collaborate with Data Management on CRF design, CRF instructions, and data quality plans.
• Review data‑driven sections of regulatory and clinical reporting documents (e.g., CSRs, INDs, NDAs/BLAs, annual reports, IBs, etc.).
• Provide scientific writing support, including patient narratives, abstracts, posters, and presentations.
• Mentor and train junior staff.
• Utilize visual analytics tools to interpret and communicate data insights.

The duties and responsibilities listed