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Clinical Scientist

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Actalent

Yesterday

  • Job
    Full-time
    Senior Level
  • Science
    Healthcare
  • Alameda
    Remote

AI generated summary

  • You need 5 years of data review, 3+ years in oncology, TFL review experience, medical safety data review, results evaluation, and a Master’s degree or higher.
  • You will review scientific data, develop protocols, prepare reports, validate study documentation, collaborate with teams, ensure compliance with regulations, and focus on data accuracy.

Requirements

  • 5 years of data review
  • 3+ years of data review in oncology
  • Experience with TFL Review
  • Medical Safety Data Review
  • Results evaluation/review
  • Completed Master's degree or higher

Responsibilities

  • You will have key relationships internally with the clinical project (study) team and other study stakeholders.
  • Review scientific data and develop product knowledge to understand and communicate relevant information for one or more clinical studies.
  • Develop and review various study protocols with minimal guidance, including writing, reviewing, adjudication/resolution of cross-functional comments, and ensuring a high-quality final document.
  • Prepare and present reports and presentations on the findings of clinical research.
  • Regularly review information to check safety procedures, efficiency, and the lab data's accuracy and correctness.
  • Review and validate clinical study reports (CSRs) with a thorough understanding of the connection between the data and the CSR.
  • Contribute to, coordinate, and review regulatory documents, Consent Forms (ICF), and other relevant study materials.
  • Collaborate with all study team members including Clinical/Medical Affairs, Clinical Operations, Drug Safety, Regulatory Affairs, and external vendors.
  • Meet deadlines and milestones required based on assigned study goals.
  • May be asked to participate in protocol design, writing, and implementation to meet GCP, ICH, and regulatory requirements.
  • May be asked to provide input into the drug development and evidence generation process as a technical expert.
  • 80% of the role will involve data review.

FAQs

What is the primary responsibility of a Clinical Scientist in this role?

The primary responsibility is to review scientific data, develop product knowledge, and communicate relevant information for clinical studies, with about 80% of the role focused on data review.

Is prior experience in oncology required for this position?

Yes, a minimum of 3 years of data review experience specifically in oncology is required.

What educational qualifications are necessary for this role?

A completed Master's degree or higher is required for this position.

Will this position involve collaboration with other teams?

Yes, the Clinical Scientist will collaborate with various study team members, including Clinical/Medical Affairs, Clinical Operations, Drug Safety, and Regulatory Affairs.

Are there specific regulatory guidelines that need to be followed in this job?

Yes, the role may involve participation in protocol design, writing, and implementation to meet Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and other regulatory requirements.

Does the job require travel?

No, this is a fully remote position with no travel required.

What types of documents will the Clinical Scientist contribute to?

The Clinical Scientist will contribute to regulatory documents, Consent Forms (Informed Consent Forms), and various study materials.

How does Actalent promote diversity and inclusion in the workplace?

Actalent promotes diversity and inclusion by hiring diverse talent, maintaining an inclusive environment, building a culture of care, and ensuring growth opportunities for all employees.

What percentage of this role is focused on data review?

Approximately 80% of the role involves data review.

How should applicants request accommodations during the application process?

Applicants can request reasonable accommodations by emailing actalentaccommodation@actalentservices.com for options related to the job application or interviewing process due to a disability.

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Mission & Purpose

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference. Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research. Actalent is an operating company of Allegis Group, the global leader in talent solutions.