Clinical Scientist — Data-Driven Clinical Insights

Worldwide Clinical Trials Holdings, Inc.; North Carolina; Hybrid; USD 79,000 - 157,000; Full time

Job summary

Worldwide Clinical Trials Holdings, Inc. is seeking a Clinical Scientist to review, interpret, and assess clinical data for clients and study teams. This role collaborates with Medical Monitors to ensure high data integrity and timely reporting across CSR and regulatory documents.

The ideal candidate has extensive experience in oncology data review, strong knowledge of GCP/ICH standards, and proficiency with EDC and data visualization tools, with travel as needed.

Qualifications

• Advanced clinical or scientific degree preferred (e.g., PharmD, PhD).
• Proven experience in oncology data review and interpretation.
• Proficiency with EDC systems and data visualization platforms.
• Strong knowledge of GCP/ICH and regulatory requirements.

Responsibilities

• Develop and implement clinical data review plans for assigned studies.
• Collaborate with cross-functional study teams to ensure proper data collection and reporting.
• Conduct ongoing review/analysis of clinical data (efficacy, safety) using listings and CSR inputs.
• Track and analyze potential safety events with Pharmacovigilance and Medical Monitoring.
• Prepare data summary slides for Safety Review Committee and Data Review Meetings.
• Present key data trends to Medical Monitor, Study Team, and Client.
• Query data in EDC with timely follow-up and identify protocol deviations.
• Partner with vendors and team members for accurate endpoint reporting.
• Serve as a resource for site staff and monitors on protocol/clinical inquiries.
• Collaborate with Data Management on CRF design and data quality plans.
• Review data-driven sections of regulatory documents (CSRs, INDs, NDAs/BLAs).
• Provide scientific writing support (narratives, abstracts, posters, presentations).
• Mentor and train junior staff; use visual analytics to communicate insights.

Skills

Clinical development

Safety concepts

Clinical data analysis

EDC systems

GCP/ICH standards

Communication skills

Organization & problem-solving

Multi-tasking

Interpersonal skills

Independence

Decision making

Willingness to travel

Education

Advanced clinical or scientific degree

Bachelor’s degree in a relevant field

Tools

EDC systems

Data visualization tools

Job description

Worldwide Clinical Trials Holdings, Inc. is seeking a Clinical Scientist to review, interpret, and assess clinical data for clients and study teams. This role collaborates with Medical Monitors to ensure high data integrity and timely reporting across CSR and regulatory documents.

The ideal candidate has extensive experience in oncology data review, strong knowledge of GCP/ICH standards, and proficiency with EDC and data visualization tools, with travel as needed.