Clinical Research Scientist

5 days ago


Boston, Massachusetts, United States Teema Staffing Full time
Job Title: Clinical Scientist

Job Summary:

We are seeking a highly motivated and experienced Clinical Scientist to join our team at Teema Staffing. As a Clinical Scientist, you will be responsible for leading clinical development activities, including the design, execution, and interpretation of clinical trials, as well as providing clinical science input to study management teams.

Key Responsibilities:

  • Lead development of clinical development plans, study synopses, and protocols
  • Provide clinical science input to protocol-related documents and processes
  • Review data during trial conduct and address quality issues
  • Provide oversight for clinical science activities performed by external vendors
  • Maintain knowledge of regulatory requirements and ensure GCP compliance
  • Contribute to briefing packages and respond to health authority questions
  • Review clinical regulatory documents and provide clinical and scientific input
  • Develop and implement EMA PIP and FDA PSP
  • Provide clinical scientific input for final study reports and annual reports
  • Represent clinical science in study management teams

Requirements:

  • PhD-/MD-/PharmD-level (or equivalent relevant experience) and five or more years of experience in clinical drug development
  • Proven experience in design, conduct, and data analysis of registration-track global clinical trials
  • Substantial experience as an academic principal investigator for industry-sponsored trials
  • Thorough knowledge of own therapeutic area or disease-specific information
  • Experience in interactions with ethics committees, regulatory authorities, and other external agencies
  • Previous experience in providing oversight to vendor activities
  • Demonstrated experience managing complex projects and influencing diverse stakeholders

What We Offer:

Teema Staffing offers a dynamic and collaborative work environment, competitive compensation, and opportunities for professional growth and development.


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