Clinical Scientist (Manager/Senior Manager), Oncology

Volastra • New York, NY

227d • $115,000 - $170,000 • Hybrid

About The Position

The Clinical Scientist will report to the Senior Director, Clinical Science and will work collaboratively with the clinical team to contribute to the development, evaluation and execution of Volastra's oncology programs. The Clinical Scientist will be assigned to one or more clinical trials and be responsible for ensuring the scientific integrity of the trials. The ideal candidate is highly self-motivated, detail oriented and has relevant clinical experience. Volastra is a fast-paced biotech company of passionate employees, and there is ample opportunity for the ideal candidate to grow and develop with the organization. Individuals will from time to time have the opportunity to gain experience with projects outside their direct scope of work. Job is based in NYC with a flexible option for hybrid work.

Requirements

• Master's Degree required, further advanced degree in related field preferred
• Minimum of 5 years of highly relevant experience related to conduct of clinical trials
• Experience in oncology required, experience in early phase trials preferred
• Strong working knowledge of FDA, ICH, GCP guidelines and other relevant regulatory requirements
• Experience working with EDC systems
• Strong analytical skills and attention to detail with the ability to work with large data sets and ensure consistency across the clinical study databases.
• Ability to navigate and succeed in a dynamic environment with collaboration and teamwork
• Excellent communication, organizational, problem-solving and conflict resolution skills
• Demonstrated scientific writing skills and communications skills in English
• Ability to travel domestically (<10%)

Responsibilities

• Collaborates closely with the Medical Monitor(s) to provide scientific input on planning, evaluation and analysis of clinical programs and trials
• Supports clinical data review and interpretation including subject eligibility review and monthly listing review
• Reviews emerging clinical data and supports identification of data trends and potential inconsistencies; raises appropriately to the clinical team.
• Supports safety monitoring activities and procedures to ensure patient safety and compliance with reporting requirements, including review of SAE narratives.
• Maintains data integrity and quality of clinical trial(s) in support of the development strategy for all assigned programs
• Collaborates with cross functional study team as appropriate to execute clinical study deliverables
• Assist with preparation/review of protocol and other study documents including medical monitoring plans, SAPs, informed consents, IBs, site training materials/presentations, and clinical components of the Clinical Study Reports and regulatory documents.
• Answers site specific protocol questions as appropriate
• Contributes to meetings with internal and/or external stakeholders where clinical data is presented/discussed
• Ensures compliance with FDA, GCP and other applicable guidelines as well as SOPs
• Maintains knowledge of therapeutic areas including standard practices, and stays abreast of competitive landscape

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Master's degree
• Number of Employees: 11-50 employees