Clinical Scientist

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies.

As a Clinical Scientist, you are a key member of the Clinical Oncology Operations, Clinical Science Team. Your main responsibilities include reviewing, understanding, and assessing clinical data before it is reviewed by Medical/Client. You will communicate and present relevant trends and findings of the clinical review to the Study Team and the Client. You will work closely with the Study Team to ensure that the clinical database and regulatory projects, such as Clinical Study Reports (CSRs), maintain the highest level of integrity. Additionally, you will collaborate with the Client, subcontractors, and Catalyst Study Team members to meet project timelines and Client expectations for data review. You will also assist in reviewing CRFs, data quality review plans, and other clinical study reports, among other tasks. You may propose methods to improve collaboration, efficiency, and data review deliverables to the Chief Scientific/Medical Officer, Clinical Operations, and Biometry.

Position Responsibilities/Accountabilities:

• Partner with the Study Team in developing data review plans for clinical studies.
• Collaborate with Study Team members (e.g., Medical, Statistics) to ensure protocol-defined variables are reported/collected appropriately.
• Review and interpret clinical data, including efficacy and safety endpoints, to derive meaningful insights.
• Track and analyze potential safety events across trials.
• Communicate and present clinical trends/findings to the Project Medical Monitor, Study Team, and Client.
• Discuss study modifications or strategy changes based on clinical data review.
• Create data summary slides for Safety Review Committee Meetings (SRCs), DSMBs, and Data Review Meetings.
• Collaborate with Study Team members and vendors to ensure accurate reporting of endpoints.
• Partner with Data Management on CRF design and instructions.
• Create queries on EDC data, follow up, and identify protocol deviations.
• Develop study-specific listings to support clinical dashboards.
• Serve as point of contact for site staff regarding study protocol and inquiries.
• Review and contribute to Study Management Plans.
• Perform informal UAT testing for clinical dashboards.
• Review data sections of regulatory reporting documents and provide input.
• Mentor and train staff as needed.
• Contribute to scientific writing for projects such as narratives, abstracts, posters, and presentations.

Position Qualifications/Requirements:

Experience: 8+ years in industry or related fields, or a Bachelor's degree in life sciences or nursing with 12+ years of relevant experience. Required Skills include extensive knowledge of clinical development, study design, product and safety profiles, data analysis, and interpretation, experience with electronic data capture and visualization tools, GCP/ICH knowledge, proficiency in Microsoft Office, excellent communication and organizational skills, ability to manage multiple projects, and willingness to travel.