Remote Senior Clinical Scientist: Medical Operations Lead

Parexel; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a Senior Clinical Scientist to lead or support studies, taking accountability for the clinical and scientific execution of the protocol. You will act as the clinical lead on the Clinical Trial Team and partner with cross-functional colleagues to manage trial design, monitoring, data review, and regulatory aspects.

The role involves coordinating medical monitoring plans, reviewing SAE reports, and contributing to CSR/CTD development, with opportunities to mentor other CSs and

Qualifications

• Minimum 7 years with BS/BA or 5 years with MS/PhD in pharmaceutical and/or clinical drug development in the last 10 years.
• Minimum 2 years as a lead CS (phase I-IV clinical trials) with pharma/biotech/CRO experience in the last 5 years.
• Minimum 2 years medical monitoring experience (adverse events review, lab data).

Responsibilities

• Leads or supports one or more trials; leads clinical execution of the protocol when acting as lead.
• Serve as Clinical point of contact for scientific issues for internal/external stakeholders (e.g., IRB, sites).
• Contributes to trial design and endpoint development with Clinical Development.
• Provides scientific input to data management activities (EDC, DRP, CRFs).
• Reviews specifications, allocation requests, and schedules in the allocation system.
• Coordinates planning for labs, biospecimens, and imaging specifications.

Skills

Clinical trial leadership

Medical monitoring

Data review

Regulatory knowledge

MS Office

Communication skills

Education

Degree in Life Sciences

BS/BA/MS/PhD

Job description

Parexel is seeking a Senior Clinical Scientist to lead or support studies, taking accountability for the clinical and scientific execution of the protocol. You will act as the clinical lead on the Clinical Trial Team and partner with cross-functional colleagues to manage trial design, monitoring, data review, and regulatory aspects.

The role involves coordinating medical monitoring plans, reviewing SAE reports, and contributing to CSR/CTD development, with opportunities to mentor other CSs and