Remote Local Study Director (Oncology & Cell Therapy)

Parexel; Olympia (WA); Remote; USD 110,000 - 150,000; Full time

Job summary

Parexel is seeking Local Study Associate Directors (LSAD) for remote roles in the United States. The LSAD leads Local Study Team(s) to deliver clinical study components in compliance with ICH-GCP, client SOPs, and local regulations.

Oncology experience and a preference for cell therapy are required or strongly preferred. The LSAD may perform site monitoring, identify sites, perform site qualifications, and manage CTMS/local web setup; supports recruitment strategies and risk management at

Qualifications

• 3+ years of development operations or related clinical study roles
• Knowledge of ICH-GCP and local regulations
• Fluent in English; local language skills desirable

Responsibilities

• Leads Local Study Team to deliver trial components on time and within budget
• Identifies potential sites, performs site qualification visits and feasibility assessments
• Coordinates site selection, monitoring from activation to study closure
• Manages regulatory submissions and document archiving (eTMF)
• Plans budgets, contracts, and payments per local regulations
• Ensures compliance with SOPs, ethics codes and client requirements
• Trains and coaches LST members and supports audits/regulatory inspections
• Maintains risk management plans and communications with stakeholders

Skills

Cross-functional leadership

Project management

Team building

Organizational skills

Communication skills

English proficiency

Local language fluency

Negotiation skills

IT systems adaptation

Attention to detail

Education

Bachelor's degree in life sciences or related field

Tools

CTMS

eTMF

Job description

Parexel is seeking Local Study Associate Directors (LSAD) for remote roles in the United States. The LSAD leads Local Study Team(s) to deliver clinical study components in compliance with ICH-GCP, client SOPs, and local regulations.

Oncology experience and a preference for cell therapy are required or strongly preferred. The LSAD may perform site monitoring, identify sites, perform site qualifications, and manage CTMS/local web setup; supports recruitment strategies and risk management at