Clinical Scientist (Manager/Senior Manager), OncologyLocation: New York, NY - This role is hybrid onsite. Candidates must be open to relocating to NYC or be able to commute into the city 2-3 times per week.Scientific Search has recently partnered with a clinical-stage pharmaceutical company pioneering novel approaches to treating cancer. They're looking for a Clinical Scientist, who 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 oncology programs.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.
- Ensures compliance with FDA, GCP and other applicable guidelines as well as SOPs
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.
Base salary of approximately $115,000- $170,000 which may vary depending on qualifications, experience, and ultimate leveling.How To Apply: We'd love to see your resume, but we don't need it to have a conversation. Send us an email to ...@scientificsearch.com and tell me why you're interested. Or, feel free to email your resume.