Senior Medical Operations Leader (Remote)

Parexel; Lansing (MI); Remote; USD 140,000 - 190,000; Full time

Job summary

Parexel is seeking a Senior Clinical Scientist to lead or support complex studies, ensuring the clinical and scientific execution of protocols. The role acts as the clinical point of contact for scientific questions with internal and external stakeholders, including IRBs and sites, and collaborates on study design and endpoint development with the CD.

The SCS leads the Medical Monitoring team, reviews SAE reports, and participates in governance, CSR planning, and publications as needed.

Qualifications

• 7+ years in pharmaceutical/clinical drug development (BS/BA).
• 2+ years as a lead Clinical Scientist in phase I–IV.
• 2+ years medical monitoring experience.
• Oncology TA experience preferred (IDV/GSM).

Responsibilities

• Lead or support studies; accountable for protocol execution.
• Clinical POC for scientific issues with internal/external stakeholders.
• Develop trial design and endpoints with CD.
• Lead Medical Monitoring; review SAE reports.
• Coordinate planning for labs, bio specimens and imaging specs.
• Contribute to CSRs, CTDs/WMAs with medical writing.
• Ensure Parexel standards and GCP compliance.
• Mentor other Clinical Scientists.

Skills

Data review

Communication skills

MS Office

Team leadership

Clinical trial knowledge

Protocol understanding

Education

BS/BA Life Sciences

MS/PhD Life Sciences (preferred)

Tools

SPECTRUM

EDC systems

Job description

Parexel is seeking a Senior Clinical Scientist to lead or support complex studies, ensuring the clinical and scientific execution of protocols. The role acts as the clinical point of contact for scientific questions with internal and external stakeholders, including IRBs and sites, and collaborates on study design and endpoint development with the CD.

The SCS leads the Medical Monitoring team, reviews SAE reports, and participates in governance, CSR planning, and publications as needed.