Clinical Scientist

This is a fully remote position, open to applicants in Illinois, +10 more states.

📋 Description

• Create oncology clinical data review plans for designated studies.

• Perform continuous oncology clinical data review and analysis, encompassing efficacy and safety-related data, utilizing listings, visual analytics, tables, figures, graphs, and EDC.

• Share significant oncology data trends and insights with the Medical Monitor, Study Team, and Client.

• Work in collaboration with cross-functional study team members to ensure accurate collection and reporting of protocol-defined variables.

• Monitor and analyze potential safety events in conjunction with Pharmacovigilance and Medical Monitoring.

• Participate in discussions regarding potential modifications to study or strategy based on clinical data reviews.

• Develop data summary presentations for Safety Review Committee Meetings and Data Review Meetings.

• Query EDC data during clinical reviews, follow up efficiently, and identify possible protocol deviations.

• Collaborate with vendors and study team members to guarantee accurate endpoint reporting.

• Act as a point of contact for site staff and monitors regarding protocol and clinical inquiries.

• Partner with Data Management on CRF design, CRF instructions, and data quality strategies.

• Evaluate data-driven sections of regulatory and clinical reporting documents, including CSRs, INDs, NDAs/BLAs, annual reports, and IBs.

• Offer scientific writing assistance for patient narratives, abstracts, posters, and presentations.

• Mentor and train junior team members.

• Employ visual analytics tools to interpret and convey data insights.

⛳️ Requirements

• In-depth knowledge of oncology clinical development processes and study design principles.

• Comprehensive understanding of oncology product profiles and safety concepts, including DCs, bi-specific antibodies, and CAR-T.

• Experience in reviewing clinical data for solid tumors, liquid tumors, and imaging.

• Clinical knowledge of the physiological and pathological effects of oncology disease states and anticancer therapies on human organ systems.

• Expertise in oncology clinical data analysis, interpretation, and evaluation of clinical relevance in human clinical trials.

• Proficiency with electronic data capture systems and data visualization tools.

• Solid grasp of GCP, ICH guidelines, and regulatory requirements.

• Exceptional written and oral communication, along with presentation skills.

• Strong organizational, analytical, and problem-solving capabilities.

• Capacity to manage multiple priorities and adapt to evolving demands.

• Excellent interpersonal skills with the ability to collaborate across teams and levels.

• Proven ability to work independently and as part of a team.

• Sound judgment and decision-making abilities.

• Willingness to travel as necessary.

• Preferred advanced clinical or scientific degree, such as PharmD, PhD, MSN, or ARNP.

• Over 8 years of industry-related experience in Oncology.

• Proficiency in Microsoft Office Suite.

• Experience with EDC systems and data visualization platforms.

🏝️ Benefits

• Competitive benefits package based on location.

• Transparent compensation and pay equity.

• Inclusive and equitable workplace.