ResearchEd

Associate Clinical Scientist / Clinical Scientist

ResearchEd

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

JuniorMid-Level

Tech Stack

Google Cloud Platform

About the role

  • Review, understand, and assess clinical data before Medical/Client review.
  • Communicate and present relevant trends and findings to the Study Team and the Client.
  • Ensure clinical database and regulatory projects (e.g., Clinical Study Reports) maintain the highest level of integrity.
  • Collaborate with the Client, subcontractors, and Catalyst assigned Study Team members to meet project timelines and Client expectations.
  • Assist in the review of CRFs, data quality review plans, and other clinical study reports.
  • Partner with the Study Team in the development of data review plans for individual clinical studies and CRF design.
  • Provide continuous review and interpret relevant clinical efficacy and safety endpoint data across listings and visual analytics.
  • Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s).
  • Create data summary slides for Safety Review Committee Meetings, DSMBs, and Catalyst Data Review Meetings.
  • Create queries on EDC data as needed during Clinical review, provide timely follow up and identify potential protocol deviations.
  • Assist in the development of study-specific listings and perform informal UAT testing for project level Clinical analytic dashboards.
  • Review and provide input on data driven sections of reporting documents, such as INDs, BLA/NDAs, Annual Report, IBs, briefing books, CSRs, IMPDs, etc.
  • Mentor and/or train staff and provide scientific writing for subject/patient narratives or non-regulatory documents such as abstracts, posters, and oral presentations.
  • Serve as point of contact for site staff and monitors regarding study protocol and clinical inquiries.
  • Fluent in Visual Analytics interpretation.

Requirements

  • 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.