Jobs · Analyst

Clinical Scientist - Oncology - US - Remote

Worldwide Clinical Trials · Triangle, NC · 3 wk ago
RemoteRemoteAnalystFull-time

About the role

The Clinical Scientist leads the review and assessment of clinical data, ensuring it meets the highest standards of quality and integrity. This role translates complex data into clear insights, communicates trends to internal teams and clients, and supports the development of key regulatory deliverables such as clinical study reports.

Responsibilities

  • Partner with cross-functional Study Teams (Medical, Biostatistics, Data Management) to develop and execute data review plans, ensuring accurate collection and reporting of protocol-defined endpoints.
  • Perform ongoing review and interpretation of clinical data (efficacy and safety) across listings and visual analytics, identifying trends and generating actionable insights.
  • Monitor and analyze safety events across studies and programs, supporting risk identification, escalation, and informed decision-making.
  • Communicate and present clinical findings, trends, and recommendations to Study Teams, Medical leadership, and clients; contribute to strategic discussions and study modifications.
  • Support development of key deliverables, including clinical study reports (CSRs), regulatory documents (e.g., INDs, NDAs/BLAs, IBs), and data summaries for SRCs, DSMBs, and internal review meetings.
  • Collaborate on CRF design, data quality processes, and EDC query management; identify protocol deviations and ensure data integrity in partnership with internal teams and vendors.
  • Contribute to study execution and continuous improvement efforts, including dashboard/UAT support, study documentation, scientific writing (e.g., narratives, abstracts), and mentoring of junior staff.

Requirements

Strong knowledge of the clinical development process, study design principles, and product safety profiles. Experience in clinical data analysis, interpretation, and translating insights into clinical relevance. Proficiency with electronic data capture (EDC) systems, data visualization tools, and Microsoft Office (Excel, PowerPoint, Word). Solid understanding of GCP, ICH, and applicable regulatory requirements. Excellent communication and presentation skills, with the ability to convey complex data clearly to diverse stakeholders. Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities and meet deadlines. Collaborative, adaptable team player with strong interpersonal skills and the ability to work effectively across all levels of an organization.

Qualifications

Advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH, etc.) preferred. 8+ years of industry/related experience in Oncology human clinical trial research including review and interpretation of clinical data.

Skills

Knowledge of clinical development process, study design principles, and product safety profiles. Experience in clinical data analysis, interpretation, and translating insights into clinical relevance. Proficiency with electronic data capture (EDC) systems, data visualization tools, and Microsoft Office (Excel, PowerPoint, Word). Solid understanding of GCP, ICH, and applicable regulatory requirements. Excellent communication and presentation skills, with the ability to convey complex data clearly to diverse stakeholders. Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities and meet deadlines. Collaborative, adaptable team player with strong interpersonal skills and the ability to work effectively across all levels of an organization.

Benefits

We offer a competitive compensation package, comprehensive benefits, professional development opportunities, and a supportive work environment.

Pay

Competitive salary based on experience and qualifications.

Schedule

Full-time position with flexible working hours.

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