Remote Senior Clinical Operations Leader

Parexel; Salem (OR); Remote; USD 130,000 - 210,000; Full time

Job summary

Parexel is seeking a Senior Clinical Scientist to lead or support studies, ensuring the clinical and scientific execution of protocols. The role includes acting as the clinical point of contact for scientific issues with internal and external stakeholders and leading Medical Monitoring activities.

Candidates should have substantial experience in pharma/biotech clinical development, oncology TA exposure, and prior leadership in CS roles.

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 (phase I-IV) in the last 5 years.
• Minimum 2 years medical monitoring experience in reviewing patient data and resolving discrepancies.
• TA-specific experience in Oncology; IDV and GSM preferred.
• Indication-specific experience preferred.

Responsibilities

• Lead or support studies; accountable for clinical/scientific execution of the protocol.
• Clinical point of contact for scientific issues/questions for internal and external stakeholders.
• Lead Medical Monitoring and develop the Medical Monitoring Plan; review SAE reports.
• Contribute to trial design, endpoints, governance, and CL/CSR related activities.
• Provide scientific input to data management and SM activities; support publications/presentations as needed.
• Mentor other Clinical Scientists and collaborate with medical writing on trial results communication.

Skills

Data issue resolution

Communication skills

MS Office proficiency

Team leadership

Education

BS/BA Life Sciences

MS/PhD Life Sciences

Job description

Parexel is seeking a Senior Clinical Scientist to lead or support studies, ensuring the clinical and scientific execution of protocols. The role includes acting as the clinical point of contact for scientific issues with internal and external stakeholders and leading Medical Monitoring activities.

Candidates should have substantial experience in pharma/biotech clinical development, oncology TA exposure, and prior leadership in CS roles.