Oncology Clinical Study Manager – Industry Trials Lead

Alliance for Clinical Trials in Oncology; Chicago (IL); Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

8 weeks PTO

Medical, Dental & Vision plans

Continuing Education

3% employer retirement match

Annual Bonus Program

Cost of Living Adjustment

Commuter reimbursement

Healthy Work/Life balance

Job summary

The Alliance Foundation is seeking a Clinical Study Manager to lead project management and clinical study activities for oncology trials. The role involves collaboration with industry partners on NDA and non-NDA registration trials, on-site monitoring, and quality management of assigned studies.

Responsibilities include developing project plans, coordinating cross-functional teams, ensuring inspection readiness, and managing budgets and vendor relationships.

Qualifications

• Minimum of a BA/BS degree.
• Minimum of 3 years of pharmaceutical, biotech, CRO, or site experience in clinical research.
• Experience in supporting trial development, implementation, and completion.
• Proficiency in Microsoft Office programs and business-level computer skills.
• Knowledge of the drug development process and FDA regulations.

Responsibilities

• Proactively identifies, assesses, documents, escalates, and manages study risks and operational issues; develops and implements mitigation and corrective action strategies.
• Develops and maintains detailed project plans, schedules, project projections, resource plans and status reports.
• Leads and coordinates cross-functional team activities for assigned clinical trials.
• Supports study development and leads the operational planning, implementation, conduct, and management of studies from initiation through completion.
• Represents Industry collaborations on the cross-functional project team and liaises with medical, regulatory, quality, protocol, legal, statistical, data management, and financial personnel.

Skills

Project management

Study management

Vendor oversight

Cross-functional leadership

Regulatory knowledge

ICH-GCP knowledge

Communication

Budget oversight

Education

BA/BS degree

Tools

EDC

MS Office

Job description

The Alliance Foundation is seeking a Clinical Study Manager to lead project management and clinical study activities for oncology trials. The role involves collaboration with industry partners on NDA and non-NDA registration trials, on-site monitoring, and quality management of assigned studies.

Responsibilities include developing project plans, coordinating cross-functional teams, ensuring inspection readiness, and managing budgets and vendor relationships.