Remote Local Study Director – Oncology Trials

Parexel; City of Albany (NY); Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking Local Study Associate Directors (LSADs) for remote roles in the United States. Oncology experience is required, with cell therapy preferred. The LSAD leads Local Study Teams and ensures country-level study delivery, quality, and regulatory compliance.

The role may include site monitoring, site qualification, CTMS setup, and coordination of local drug activities. Strong leadership, communication, and regulatory knowledge are essential for success.

Qualifications

• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or related fields.
• Good knowledge of ICH-GCP and local regulations.

Responsibilities

• Leads Local Study Team(s) at country level to deliver study commitments.
• Oversees monitoring activities from site activation to study closure.
• Coordinates site selection and Site Qualification Visits to assess quality.
• Plans local drug activities including purchase, reimbursement, and destruction as needed.
• Assists in regulatory submissions and regulatory inspections coordination.
• Maintains and updates the eTMF and study documentation as required.

Skills

Cross-functional leadership

Project management

Team building

Organizational skills

Communication skills

English proficiency

Intercultural awareness

Negotiation skills

IT systems proficiency

Education

Bachelor's degree in Life Science

Tools

CTMS

eTMF

Job description

Parexel is seeking Local Study Associate Directors (LSADs) for remote roles in the United States. Oncology experience is required, with cell therapy preferred. The LSAD leads Local Study Teams and ensures country-level study delivery, quality, and regulatory compliance.

The role may include site monitoring, site qualification, CTMS setup, and coordination of local drug activities. Strong leadership, communication, and regulatory knowledge are essential for success.