- Posted: over a month ago
Catalyst Clinical Research is a niche provider of clinical research services through two established solutions- Catalyst Flex and Catalyst Oncology. Here at Catalyst Clinical Research we provide support and services exclusively to biotech companies because we know and understand the biotech environment. Our 15+ years of experience allow us to quickly grasp the evolving needs of our clients so we can deliver the solutions essential to meet the evolving needs and unexpected changes inherent in oncology development. When protocols amend or emerging data suggest a breakthrough straight from Phase I to registration, we are ready.
Position Summary: As a Clinical Scientist you will be a key member of the Clinical Development Operations, Clinical Science Team. You will be responsible for providing specific review, understanding and preliminary assessment of clinical data prior to Medical/Client review. You will also be responsible for communicating and presenting the relevant trends/findings of the clinical review to the Study Team and the Client. In collaboration with the Study Team, you will ensure through the review of the clinical data that the highest level of integrity exists in the clinical data base and regulatory projects (e.g., Clinical Study reports [CSRs]). You will work with the Client, subcontractors, and Catalyst Clinical Research, LLC. Assigned Study Team members to meet contracted project timeline and Client expectations as they relate to the clinical review of data. You will rise to the Chief Medical Officer, Clinical Operations, and Biometry, methods to improve the overall collaboration, efficiency, and excellence with which the data-related review deliverables are achieved. As requested by the manager, you will interact and collaborate in the data-related review of CRFs and clinical study reports, etc.
- 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.
- Experience with Visual Analytics interpretation.
Supervisory Requirements/Responsibilities: N/A
Position Qualifications and Requirements:
Education: Advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH, etc.) preferred.
Experience: 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.
Required Certifications: N/A
- 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.
Working Conditions: Sedentary work that primarily involves sitting/standing.
Catalyst Clinical Research, LLC is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Catalyst Clinical Research LLC
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