Remote Senior Clinical Trials Leader

Parexel; Phoenix (AZ); Remote; USD 140,000 - 200,000; Full time

Job summary

Parexel is seeking a Senior Clinical Scientist to lead or support clinical studies, ensuring the clinical and scientific execution of trials and coordinating with internal and external stakeholders.

The role includes leading the Medical Monitoring team, authoring protocol clarifications, and contributing to study documents while ensuring adherence to Parexel processes and ICH-GCP guidelines.

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 Clinical Scientist on phase I–IV trials with pharma/biotech/CRO in the last 5 years.
• Minimum 2 years medical monitoring experience (adverse events, labs, data review).
• TA-specific experience in Oncology; IDV and GSM preferred.
• Indication-specific experience preferred.

Responsibilities

• May lead or support a study or studies; lead if assigned, accountable for clinical/scientific execution of the protocol.
• Serve as Clinical point of contact for scientific issues with internal and external stakeholders (e.g., IRB, sites).
• Design trials and endpoints in collaboration with CD; act as Scientific lead on Clinical Trial Team (CTT).
• Lead Medical Monitoring activities, develop MMP, review SAE reports, and monitor data safety signals.
• Coordinate lab, bio-specimen and imaging specs; contribute to study documents (SMP, CSR) and CSR-related planning.
• Support publications/presentations; assist in protocol deviations and data management interactions (EDC, DRP, CRFs).
• Mentor other CSs; provide clinical specs to SM for external vendors; ensure Parexel standards and regulatory compliance.

Skills

Oral and written communication

Microsoft Office

Team leadership

Data review

Education

B.S./B.A. in Life Sciences

M.S./Ph.D. in Life Sciences

Job description

Parexel is seeking a Senior Clinical Scientist to lead or support clinical studies, ensuring the clinical and scientific execution of trials and coordinating with internal and external stakeholders.

The role includes leading the Medical Monitoring team, authoring protocol clarifications, and contributing to study documents while ensuring adherence to Parexel processes and ICH-GCP guidelines.