Remote Senior Medical Operations Lead (Clinical Trials)

Parexel; Trenton (NJ); À distance; USD 120 000 - 180 000; Plein temps

Résumé du poste

Parexel is seeking a Senior Clinical Scientist in New Jersey to lead or support studies, ensuring scientific execution of protocols and clinical trial delivery.

The SCS acts as the clinical point of contact for scientific issues for internal and external stakeholders, designs trial endpoints with the Clinical Development team, and provides scientific leadership within the Clinical Trial Team, including medical monitoring and data review activities.

Qualifications

• BS/BA with 7+ years or MS/PhD with 5+ years in pharma/clinical development within last 10 years

Responsabilités

• Lead or support studies, accountable for clinical/scientific execution of the protocol
• Serve as the Clinical point of contact for scientific issues for internal and external stakeholders (e.g., IRB, sites)
• Responsible for trial design and endpoint development in collaboration with CD
• Scientific lead on Clinical Trial Team (CTT)
• Lead Medical Monitoring activities, including development of the MMP and SAE review
• Monitor data issues requiring clinical input and review central lab reports for safety signals
• Prepare scientific slides and present protocol information at Investigator Meetings
• Contribute to study documents (e.g., SMP) and governance reviews
• Collaborate on CSR, CTD/WMAs with medical writing and support publications/presentations
• Ensure Parexel standards and ICH-GCP compliance across activities

Connaissances

Leadership

Data review & queries

MS Office proficiency

Project management

Communication skills

Formation

BS/BA in Life Sciences

MS/PhD in Life Sciences

Outils

SPECTRUM

EDC systems

Microsoft Office

Description du poste

Parexel is seeking a Senior Clinical Scientist in New Jersey to lead or support studies, ensuring scientific execution of protocols and clinical trial delivery.

The SCS acts as the clinical point of contact for scientific issues for internal and external stakeholders, designs trial endpoints with the Clinical Development team, and provides scientific leadership within the Clinical Trial Team, including medical monitoring and data review activities.