Clinical Scientist

Worldwide Clinical Trials•Atlanta, GA

About The Position

The Clinical Scientist is responsible for the review, interpretation, and assessment of oncology clinical data, specifically solid tumor data. Key findings are communicated to Clients and the study team. The Clinical Scientist works closely with the Medical Monitor as appropriate. This role communicates and presents clinical trends and findings to the Study Team and Clients while working collaboratively to ensure high-quality data, maintain the highest integrity of the clinical database and clinical study reports (e.g., CSR). The Clinical Scientist partners with Clients, subcontractors, and internal study team members to meet project timelines and expectations related to clinical data review.

Requirements

Strong knowledge of oncology clinical development processes and study design principles.
Deep understanding of oncology product profiles and safety concepts (e.g. DCs, bi-specific antibodies, CAR-T)
Experience with solid tumors, liquid tumors, imaging clinical data review
Clinical understanding of the physiological and pathological effects of oncology disease states and anticancer therapies on human organ systems.
Skilled in oncology clinical data analysis, interpretation, and assessing clinical relevance in human clinical trials, within the relevant therapeutic area.
Proficient with electronic data capture systems and data visualization tools.
Solid understanding of GCP, ICH guidelines, and regulatory requirements.
Excellent written, oral communication, and presentation skills.
Strong organizational, analytical, and problem-solving abilities.
Ability to manage multiple priorities and adapt to changing demands.
Strong interpersonal skills and the ability to collaborate across teams and levels.
Demonstrated ability to work independently and within teams.
Good judgment and decision-making skills.
Willingness to travel as needed.
Proficiency in Microsoft Office Suite.
Experience with EDC systems and data visualization platforms.

Nice To Haves

Advanced clinical or scientific degree preferred (e.g., PharmD, PhD, MSN, ARNP)

Responsibilities

Develop oncology clinical data review plans for assigned studies.
Conduct ongoing oncology clinical data review and analysis of clinical data (e.g., efficacy, safety related data components) utilizing listings, visual analytics, tables, figures, graphs, and EDC.
Present key oncology data trends and findings to the Medical Monitor, Study Team, and Client.
Collaborate with cross-functional study team members to ensure protocol-defined variables are collected and reported accurately.
Track and analyze potential safety events in collaboration with Pharmacovigilance and Medical Monitoring.
Contribute to discussions on potential study or strategy modifications based on clinical data review.
Create data summary slides for Safety Review Committee Meetings, Data Review Meetings with support from Director.
Query data as appropriate on EDC data as needed during Clinical review with timely follow up, and identification of potential protocol deviations.
Partner with vendors and study team members to ensure accurate endpoint reporting.
Serve as a point of contact for site staff and monitors for protocol and clinical inquiries.
Collaborate with Data Management on CRF design, CRF instructions, and data quality plans.
Review data-driven sections of regulatory and clinical reporting documents (e.g., CSRs, INDs, NDAs/BLAs, annual reports, IBs, etc.).
Provide scientific writing support, including patient narratives, abstracts, posters, and presentations.
Mentor and train junior staff.
Utilize visual analytics tools to interpret and communicate data insights.