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About the Role
The Clinical Scientist is responsible for reviewing, interpreting, and assessing oncology clinical data, specifically solid tumor data. Key findings are communicated to clients and the study team. This role involves presenting clinical trends and findings, ensuring data quality and integrity, and collaborating with clients and internal teams to meet project timelines.
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 continually.
- 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.
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.
Skills
- Oncology clinical data review
- Data analysis
- Data interpretation
- Electronic data capture (EDC) systems
- Data visualization tools
- GCP
- ICH guidelines
- Regulatory requirements
- Written communication
- Oral communication
- Presentation skills
- Organizational skills
- Analytical skills
- Problem-solving
- Interpersonal skills
- Scientific writing
- Microsoft Office Suite
Location
- United States of America
Work Type
- Full-time
Experience Level
- 8+ years of industry-related experience in Oncology
- Advanced clinical or scientific degree preferred (e.g., PharmD, PhD, MSN, ARNP)
Education Level
- Advanced clinical or scientific degree preferred (e.g., PharmD, PhD, MSN, ARNP)
Salary/Compensations
- $79,000.00 - $157,000.00
Benefits
- Competitive benefits package depending on location
About the Company
- Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries and innovates to find cures for persistent diseases.
- We are a global team of over 3,500+ experts dedicated to changing the way the world experiences CROs.
- Our mission is to work with passion and purpose every day to improve lives.
- We believe everyone plays an important role in making a world of difference for patients and their caregivers.
- We prioritize cultivating a diverse and inclusive environment that promotes collaboration and creativity.
- We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.
Equal Opportunity
- We are committed to fostering an inclusive and equitable workplace by providing transparent compensation.
- We ensure pay equity and transparency and comply with all applicable labor laws.