Clinical Study Manager

Alliance for Clinical Trials in Oncology

. Identify, assess, document, escalate, and manage study risks and operational issues .

Posted 9/30/2026full-timeChicago • Illinois • United StatesMid-LevelSenior💰 $90,000 - $105,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical trial management, including study planning, execution, and oversight of cross-functional teams. Proficient in regulatory compliance, budget management, and stakeholder communication within the pharmaceutical and biotech sectors.

Highest-signal resume keywords

Clinical Research ExperienceStudy ManagementProject Management ToolsOncology Research ExperienceKnowledge of ICH-GCP and FDA Regulations

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Study PlanningBudget ManagementRisk AssessmentData AnalysisTechnical Writing

Soft Skills

LeadershipProblem-SolvingOrganizational SkillsCommunication Skills

Tools & Technologies

Microsoft OfficeEDC SystemsProject Management Software

Industry Keywords

PharmaceuticalBiotechCROClinical TrialsRegulatory Compliance

About the role

Key responsibilities & impact

Identify, assess, document, escalate, and manage study risks and operational issues
Develop and implement mitigation and corrective action strategies
Develop and maintain project plans, schedules, projections, resource plans, and status reports
Lead and coordinate cross-functional team activities for assigned clinical trials
Support study development and lead operational planning, implementation, conduct, and management from initiation through completion
Review and support development of study-related materials, including monitoring reports and clinical trial agreements
Support budget development and related scope of work
Participate in vendor identification, evaluation, selection, contracting, and performance oversight
Work with Regulatory, Quality, and other staff to maintain inspection-readiness
Coordinate study information and records supporting registration objectives
Track study progress against timelines, milestones, budgets, accrual goals, and operational components
Participate in SOP and study operations process/system development and implementation
Manage multiple projects and responsibilities within time constraints
Serve as project manager for industry collaborations and vendor management
Liaise with medical, regulatory, quality, protocol, legal, statistical, data management, and financial personnel
Serve as primary point of contact for industry partners
Ensure contract deliverables are fulfilled according to milestones
Analyze study performance metrics and operational data
Oversee site performance, enrollment/accrual, study conduct, protocol compliance, operational issues, and timely completion of study activities
Implement study plans and lead accrual enhancement initiatives
Participate in and conduct visits/meetings with investigative sites, physicians, vendors, and consultants
Build relationships with site staff and address study management issues
Conduct site management while maintaining inspection-readiness
Oversee monitoring CROs, including performance, reports, deliverables, timelines, quality metrics, escalation, and follow-up
Develop and contribute to study reports, presentations, and stakeholder status updates
Contribute to study-level quality management, KPI monitoring, quality concern escalation, CAPA implementation, study documentation, and Quality Monitoring and Management Committee activities

Requirements

What you’ll need

Minimum of a BA/BS degree
Minimum of 3 years of pharmaceutical, biotech, CRO, or site experience in clinical research
Study Management experience
Experience in supporting trial development, implementation, and completion
Demonstrated knowledge of the drug development process, ICH-GCP, applicable FDA regulations, and clinical research requirements
Proficiency in Microsoft Office programs and business-level computer skills
Demonstrated knowledge of EDC and other clinical systems
Oncology Research Experience
Experience using Project Management programs/tools
Experience with CRO/vendor oversight, including performance management and issue escalation
Stakeholder management
Technical/medical writing experience (protocol, IND, ICF, etc.)
Experience managing study-specific project plans, budgets, timelines, milestones, and deliverables
Excellent organizational, leadership and problem-solving skills to lead cross-functional activities
Excellent written and verbal communication skills
Ability to successfully work both within a team and independently
Ability to travel <10%.

Benefits

Comp & perks

8 weeks of paid time off (including PTO, sick, and holidays) during year one
Medical, Dental & Vision plans with a 100% employer-paid option for employees
Tuition reimbursement stipends
Continuing Education
3% employer match for retirement investments
Annual Employee Performance Bonus Program
Annual Cost of Living Adjustment
50% commuter reimbursement
Healthy Work/Life balance and flexibility