Oncology Study Manager & Trial Lead

Kelly Science, Engineering, Technology & Telecom; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom is seeking a Study Manager to drive oncology trial progression, ensuring regulatory compliance and high performance across teams. The role emphasizes end-to-end study planning, risk mitigation, and stakeholder collaboration to meet study objectives.

Responsibilities include leading trial deliverables, coordinating local study teams, and maintaining adherence to GCP and ICH guidelines throughout the study lifecycle.

Qualifications

• Bachelor's degree in life sciences or comparable discipline.
• 2+ years of experience in pharmaceutical, clinical drug development, project management, or medical field.
• Oncology experience required.
• Solid knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.

Responsibilities

• Own end-to-end performance of assigned trial protocols from startup through closeout.
• 可能 lead Clinical Trial Team (CTT) or coordinate local study teams, ensuring collaboration and high performance.
• Lead timeline management, risk identification and mitigation, and issue resolution across the study lifecycle.
• Collaborate with internal and external stakeholders (study team, country teams, vendors, investigators/sites) to support study objectives.
• Ensure study execution complies with ICH/GCP and country regulations, quality standards.
• Lead deliverables: trial plans, country/site selection, communication plans, and close-out activities.
• Manage study-specific partners and vendors.

Skills

Project management

Communication

Leadership

Risk management

Stakeholder collaboration

Quality assurance

GCP/ICH knowledge

Education

Bachelor's degree in life sciences or related field

Job description

Kelly Science, Engineering, Technology & Telecom is seeking a Study Manager to drive oncology trial progression, ensuring regulatory compliance and high performance across teams. The role emphasizes end-to-end study planning, risk mitigation, and stakeholder collaboration to meet study objectives.

Responsibilities include leading trial deliverables, coordinating local study teams, and maintaining adherence to GCP and ICH guidelines throughout the study lifecycle.