Remote Senior Clinical Scientist - Medical Operations Lead

Parexel

Columbus (OH)

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 the clinical and scientific execution of the protocol. The role involves acting as the clinical point of contact for scientific issues with internal and external stakeholders, including IRBs and sites.

The SCS leads Medical Monitoring activities, collaborates on trial design, and provides scientific input to data management and publications.

Qualifications

  • Minimum 7 years with BS/BA or 5 years with MS/PhD in pharma/clinical development (within last 10 years).
  • Minimum 2 years as a lead CS on phase I–IV trials.
  • Minimum 2 years medical monitoring experience reviewing patient data and resolving discrepancies.
  • TA-specific experience in Oncology; IDV/GSM experience preferred.
  • Indication-specific experience preferred.
  • Proficiency in Microsoft Office; OneNote experience preferred.

Responsibilities

  • Lead or support studies; accountable for clinical/scientific execution of the protocol if leading.
  • Serve as clinical point of contact for scientific issues for internal and external stakeholders.
  • Lead Medical Monitoring (MM) activities and develop the MMP, review SAE reports.
  • Provide scientific input to data management activities (EDC, DRP, CRFs) and support CSR planning.
  • Coordinate planning of lab, biospecimens and imaging specifications; collaborate with medical writing on CSRs/WMAs.

Skills

Leadership
Clinical monitoring
Medical writing
Data review
MS Office

Education

BS/BA in Life Sciences
MS/PhD in Life Sciences

Tools

SPECTRUM
EDC
IVRS
ePRO

Job description

Parexel is seeking a Senior Clinical Scientist to lead or support complex studies, ensuring the clinical and scientific execution of the protocol. The role involves acting as the clinical point of contact for scientific issues with internal and external stakeholders, including IRBs and sites.

The SCS leads Medical Monitoring activities, collaborates on trial design, and provides scientific input to data management and publications.

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