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Catalyst Clinical Research · 1 month ago

Clinical Scientist

United States

Full-time

Remote

Senior Level

5+ years exp

Catalyst Clinical Research is a company that provides customizable solutions to the biopharmaceutical and biotechnology industries. The Clinical Scientist will play a key role in the Clinical Oncology Operations team by reviewing and assessing clinical data, communicating trends and findings, and ensuring the integrity of clinical databases and regulatory projects.

Pharmaceutical

No H1B

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

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

Qualification

Clinical development processData analysis techniquesElectronic data captureData visualization toolsGCPICH guidelinesMicrosoft Office SuiteAnalytical skillsWritten communicationOral communicationPresentation skillsOrganizational skillsProblem-solving skillsInterpersonal skillsTeam player

Required

Advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH, etc.) preferred

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/research 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, 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

For US applicants only: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa