Clinical Affairs Specialist

2 weeks ago


Cambridge, Massachusetts, United States Eliassen Group Full time

Clinical Affairs Consultant Role Overview

The Clinical Affairs Consultant role is a key position within our organization, responsible for leading the development of evidence generation strategies for assigned projects. This involves working closely with internal and external stakeholders to ensure that studies yield well-founded conclusions.

Key Responsibilities

  1. Design and develop study protocols in compliance with project standards, specifications, and applicable regulatory guidelines.
  2. Manage and oversee study execution, analysis of results, and generation of final study reports to support regulatory clearances, claims, epidemiology/surveillance, reimbursement, health economic outcomes, and/or market access.
  3. Lead the development and dissemination of evidence generated from clinical evaluation plans to deliver Clinical Evaluation Reports in accordance with EU and China requirements, Clinical Study Reports, and Clinical Summaries.
  4. Collaborate with cross-functional partners to shape and lead clinical evidence strategies for regulatory submissions, on-time within budget, and in compliance with SOPs and regulations.

Requirements

  1. MD, PhD/MS degree in Biomedical science, Epidemiology, or a related field.
  2. 7+ years of experience in clinical research/development/real-world evidence function, with a strong scientific background and deep expertise in evidence generation and clinical evaluation/RWE methodologies.
  3. Deep understanding of global clinical evidence requirements, including regulatory paths, and knowledge of applicable standards/regulations in clinical evidence generation and dissemination.
  4. Excellent communication skills, including written communication and oral presentation of scientific materials and research results.

Why Join Our Team?

The Eliassen Group is a leading provider of innovative solutions in the clinical research and development industry. As a Clinical Affairs Consultant, you will have the opportunity to work with a talented team of professionals and contribute to the development of cutting-edge evidence generation strategies.



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