Clinical Scientist/Senior Clinical Scientist

As a Clinical Scientist you are a key member in the Clinical Oncology Operations, Clinical Science Team. Your main responsibility is to review, understand, and assess clinical data before it is reviewed by Medical/Client. You will also communicates and present the relevant trends and findings of the clinical review to the Study Team and the Client. You will be working closely with the Study Team, you will 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 assigned Study Team members to meet project timelines and Client expectations for the clinical data review. You will also assists in the review of CRFs, data quality review plans, and other clinical study reports, among other tasks as needed. You may propose methods to improve collaboration, efficiency, and excellence in data-related review deliverables to the Chief

Scientific/Medical Officer, Clinical Operations and Biometry.

Position Responsibilities/Accountabilities:

• Partner with the Study Team in the development of data review plans for individual clinical studies.

• Collaborate with appropriate Study Team members (e.g., Medical, Statistics) to ensure the specific protocol defined variables are reported/collected appropriately.

• Provide continuous review and interpret relevant clinical data inclusive of efficacy and safety endpoint related data, across various formats such as listings and visual analytics, applying clinical expertise to derive meaningful insights.

• Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s).

• Responsible to communicate and present the pertinent trends/findings of the clinical research to the Project Medical Monitor or designee, Study Team, and the Client as relevant.

• Contribute to discussions with the Study Team and/or Client regarding modifications in the study and/or strategy based on the clinical review of the study data.

• Create data summary slides as applicable for Safety Review Committee Meetings (SRCs), DSMBs, and Catalyst Data Review Meetings.

• Collaborate with Study Team members (e.g., Project Managers, Project Medical Monitor, CRAs, Biometry) and any third-party vendors to ensure accurate reporting and collection of protocol defined endpoints, and associated data.

• Partner with Data Management on CRF design, instructions for unique CRFs and CRF completion guidelines.

• Create queries on EDC data as needed during Clinical review, provide timely follow up and identify potential protocol deviations on a clinical study.

• Assist in the development of study-specific listings as needed on a project to supplement clinical analytic dashboards.

• Point of contact for site staff and monitors regarding study protocol and clinical inquiries, as needed.

• Review and contribute to Study Management Plans as needed, such as Safety Review Committee Charter.

• Collaborate with and Perform informal UAT testing for project level Clinical analytic dashboards prior to production release.

• Review and provide input on data driven sections of reporting documents, such as INDs, BLA/NDAs, Annual Report, IBs, briefing books, CSRs, IMPDs, etc., as directed by Manager.

• Mentor and/or train staff.

• Provide scientific writing for such projects as subject/patient narratives or non-regulatory documents such as abstracts, posters, and oral presentations, as directed by Manager.

• Fluent in Visual Analytics interpretation

Position Qualification/Requirements:

Education: Advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH,

etc.) preferred.

Experience: 8 or more years of industry/related experience OR Bachelor's

degree in a life-science or nursing with 12 years or more of industry/research

related experience including reviewing and interpreting data.

Required Skills:

• Extensive and direct knowledge of the clinical development process as well as principles of study design.

• Comprehensive understanding of product and safety profiles.

• Experience in the principles and techniques of data analysis, interpretation, and clinical relevance.

• Experience with electronic data capture systems and data visualization tools

•Well-versed in GCP, ICH, and relevant regulatory requirements.

• Proficient with Microsoft Office Suite, inclusive of Excel, PowerPoint, Word.

• Excellent written and oral communication skills.

• Excellent presentation skills.

• Strong organizational, problem-solving, and analytical skills.

• Ability to manage priorities and workflow.

• Versatility, flexibility, and a willingness to work within constantly changing priorities.

• Proven ability to handle multiple projects and meet deadlines.

• Strong interpersonal skills.

• Ability to deal effectively with a diversity of individuals at all organizational levels.

• Commitment to excellence and high standards.

• Creative, flexible, and innovative team player.

• Ability to work independently and as a member of various teams and committees.

• Good judgement with the ability to make timely and sound decisions.

• Willingness to travel to various meetings or Client sites, including overnight trips