Senior Global Oncology Study Lead Job Indianapolis Indiana USA,Healthcare

Key Responsibilities

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Drive global clinical trials from first site activation to final patient visit—own the strategy, accelerate delivery, and shape the future of clinical research worldwide.

Required Experience

✅ 2+ years of global study management experience
✅ Experience across multiple countries/regions
✅ Phase I–III clinical trials experience (Phase III required)
✅ Oncology experience required
✅ Ability to work across multiple therapeutic areas

Job Overview

We are seeking a Global Study Manager responsible for the end-to-end planning, execution, and delivery of clinical trial site management activities across global studies. This role ensures successful site selection, activation, monitoring oversight, and closeout—while balancing speed, quality, and cost. You will serve as the primary point of contact for clients, lead cross-functional teams, and ensure compliance with ICH-GCP, regulatory requirements, and study protocols.

This is a highly visible role that combines strategic leadership, operational execution, and financial oversight.

Key Responsibilities

Global Study & Site Leadership

Lead site management strategy from study award through close-out
Oversee site identification, selection, activation, and recruitment performance
Ensure clinical monitoring processes meet study needs and timelines
Partner with CRAs to optimize enrollment, data quality, and compliance

Project & Stakeholder Management

Serve as primary client contact and own key customer relationships
Lead cross-functional teams across regions and cultures
Facilitate internal and external meetings, including executive presentations
Drive collaboration across stakeholders, vendors, and functional leads

Operational Excellence & Risk Management

Develop and manage integrated study plans and risk mitigation strategies
Proactively identify risks and implement corrective/preventative actions
Monitor study timelines, enrollment trends, and data quality metrics
Ensure compliance with GCP, SOPs, protocols, and regulatory standards

Financial & Contract Management

Manage study financials, including forecasting and revenue acceleration
Identify and manage out-of-scope work and change orders
Oversee Billing Unit Reviews (BURs) and expense approvals
Track performance against budget and Estimate at Completion (EAC)

Quality & Compliance

Maintain TMF health and ensure timely document submission
Develop quality monitoring plans and compliance metrics
Ensure adherence to study tools, training materials, and processes

Team Leadership & Development

Lead and mentor cross-functional project teams
Support CRA and team training on therapeutic areas and study-specific needs
Foster collaboration, knowledge sharing, and continuous improvement

Qualifications

Required

Bachelor’s degree in life sciences or related field
5+ years of clinical research/monitoring experience, including 2 years in a clinical study management role
Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes
Experience managing global clinical trials and multi-regional teams
Demonstrated experience in project financial management

Core Competencies

Exceptional communication and stakeholder management skills
Strong problem-solving and risk mitigation capabilities
Ability to influence without authority in matrix organizations
High attention to detail and quality-driven mindset
Proficiency in Microsoft Office and clinical systems (e.g., CTMS, EDC)

Why Join Us

Work on cutting-edge global trials across therapeutic areas
Collaborate with top talent in a dynamic, global…