Local Study Lead – Clinical Trials & Team Management

Whereby; United States; Remote; USD 85,000 - 125,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits package

Travel opportunities

Job summary

Parexel is seeking a Development Operations professional to oversee clinical trial delivery in the United States. You will manage site identification, setup, monitoring, and closure while ensuring adherence to ICH-GCP and local regulations.

Join a global life sciences partner focused on delivering patient-centric trials. You will lead cross-functional teams, develop risk plans, manage essential documents, and collaborate with regulators to drive study success and compliance.

Qualifications

• Minimum 3 years of experience in Development Operations (CRA/SrCRA) or related clinical research fields.
• Proven ability to lead cross-functional teams to deliver results on time and within budget.
• Excellent project management, organizational, and communication skills.
• Strong knowledge of ICH-GCP guidelines and local regulations.
• Bachelor's degree in life sciences or related discipline.
• Attention to detail and ability to prioritize multiple tasks.
• Good negotiation skills and ability to work with IT systems.

Responsibilities

• Lead and motivate Local Study Teams to deliver clinical trials on time, within budget, and to high quality standards.
• Manage site identification, qualification, setup, initiation, monitoring, and closure activities.
• Oversee monitoring activities from site activation through study completion per monitoring plans.
• Ensure compliance with ICH-GCP guidelines and local regulations.
• Develop and maintain risk management plans and resolve study issues.
• Manage trial documentation and regulatory submissions.
• Coordinate with regulatory authorities and ethics committees.
• Contribute to patient recruitment strategy and investigator relationships.
• Perform site monitoring to support flexible capacity models.

Skills

Project management

Cross-functional leadership

Communication skills

ICH-GCP knowledge

Regulatory compliance

Education

Bachelor's degree in life sciences

Job description

Parexel is seeking a Development Operations professional to oversee clinical trial delivery in the United States. You will manage site identification, setup, monitoring, and closure while ensuring adherence to ICH-GCP and local regulations.

Join a global life sciences partner focused on delivering patient-centric trials. You will lead cross-functional teams, develop risk plans, manage essential documents, and collaborate with regulators to drive study success and compliance.