Senior Clinical Scientist – Remote Trials and Monitoring

Parexel

Denver (CO)

Remote

USD 140,000 - 190,000

Full time

3 days ago
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Job summary

Parexel is seeking a Senior Clinical Scientist to lead or support complex studies, ensuring clinical/scientific execution of protocols. You will act as the clinical point of contact for scientific issues for internal and external stakeholders, and oversee Medical Monitoring activities including the development of the Medical Monitoring Plan and SAE review.

You will collaborate in study design, endpoint development, and regulatory/compliance activities, coordinating with medical writing and

Qualifications

  • Minimum 7 years in pharmaceutical/clinical drug development within last 10 years with BS/BA; 5 years with MS/PhD.
  • Minimum 2 years as a lead Clinical Scientist on phase I-IV studies.
  • 2+ years in medical monitoring and data review for safety and efficacy.
  • Oncology TA experience preferred (IDV and GSM).
  • Degree in Life Sciences; BS/BA or higher.

Responsibilities

  • Lead or support studies; oversee clinical/scientific execution of protocols.
  • Serve as clinical point of contact for scientific issues with internal and external stakeholders.
  • Lead Medical Monitoring activities, develop MMP, review SAE reports.
  • Contribute to study documents, governance reviews, and CSR/WMAs planning.
  • Coordinate lab, bio specimens and imaging specifications; support publications.

Skills

Data review
Oral & written comms
Team leadership
MS Office
Flexibility & delegation

Education

BS/BA Life Sciences
MS/PhD Life Sciences

Tools

Microsoft Office
OneNote

Job description

Parexel is seeking a Senior Clinical Scientist to lead or support complex studies, ensuring clinical/scientific execution of protocols. You will act as the clinical point of contact for scientific issues for internal and external stakeholders, and oversee Medical Monitoring activities including the development of the Medical Monitoring Plan and SAE review.

You will collaborate in study design, endpoint development, and regulatory/compliance activities, coordinating with medical writing and

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