Clinical Scientist
Worldwide Clinical Trials
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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Tech Stack
About the role
- 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
- Advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH, etc.) preferred.
- 8+ of industry/related experience in Oncology human clinical trial research including review and interpretation of clinical data.
- 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.
- Sound judgment, high attention to detail, and the ability to work both independently and in fast-paced, evolving environments.
Benefits
- Health insurance
- Flexible working arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical data analysisdata interpretationclinical study reportsregulatory documentsscientific writingdata quality processesprotocol deviationsdashboard supportUAT supportdata review plans
Soft Skills
communication skillspresentation skillsorganizational skillsanalytical skillsproblem-solving skillsinterpersonal skillscollaborative skillsadaptabilityattention to detailjudgment
Certifications
PharmDPhDMSNMPH