Note: The job is a remote job and is open to candidates in USA. Worldwide Clinical Trials is a global midsize CRO dedicated to improving lives through innovative clinical research. The Clinical Scientist will lead the review and assessment of clinical data, ensuring quality and integrity while collaborating with cross-functional teams to drive project delivery and support regulatory deliverables.
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
Skills
- 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
- 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
Company Overview
Company H1B Sponsorship