Clinical Scientist

Summary

Join Catalyst Clinical Research, LLC as a Clinical Scientist and become a key member of the Clinical Development Operations, Clinical Science Team. You will be responsible for reviewing and assessing clinical data, communicating findings to the study team and clients, and ensuring data integrity in regulatory projects. Collaboration with various team members, including clients and subcontractors, is crucial to meet project timelines and expectations. You will contribute to improving collaboration and efficiency in data review processes. The role involves working with clinical data, identifying trends, and contributing to study modifications based on data analysis. Mentoring and training staff may also be part of your responsibilities.

Requirements

• Advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH, etc.)
• 5 or more years of industry/related experience OR Bachelor’s degree in a life-science or nursing with 10 years or more of industry/related experience including reviewing and interpreting data
• 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
• 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

Responsibilities

• 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 as well as the review of relevant data and analyses on an ongoing basis such as but not limited eligibility, endpoints (e.g., efficacy, safety) in the form of but not limited to listings, tables, figures, graphs, etc
• Responsible for communicating and presenting the pertinent trends/findings of the clinical research to the Project Medical Monitor or designee, Study Team, and the Client as relevant
• Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s)
• Responsible for review of safety and efficacy data through aggregate and patient-level data for trends, outliers and to ensure clinical soundness
• Responsible/contribute to the review and analysis of safety information in conjunction with Pharmacovigilance and the Medical Monitor or designee
• Contribute to discussions with the Study Team and/or Client regarding modifications in the study and/or strategy based on the review of the study data
• Collaborate with Study Team members (e.g., Project Managers, Project Medical Monitor, CRAs, biometry) and any third-party vendors to ensure the protocol end are reported/collected appropriately
• Assist in the development of study-specific listings with data management representatives and conduct ongoing clinical data listing reviews, as needed by the manager
• May be required to serve as primary point of contact for, and triage, clinical study inquiries from site staff and monitors regarding study protocol questions
• Partner with Data Management for CRF design, instructions for unique CRFs, and data quality review plan
• As needed by manager, review and provide input to data-driven sections of reporting documents (e.g., CSRs)
• Provide and review data as well as assist in the preparation of key documents that support regulatory submissions including INDs, BLAs/NDAs, Annual Reports, IBs, briefing books, IMPDs, etc
• Mentor and/or train staff
• As needed by the manager, provide scientific writing for such projects as subject/patient narratives or non-regulatory documents such as abstracts, posters and oral presentations

Preferred Qualifications

Experience with Visual Analytics interpretation