Director, Clinical Operations
Company: Not Specified
Location: Madison, WI (Onsite)
Job Type: Full-Time
Experience: Typically 9+ Years (Clinical Research / Clinical Operations / CRO)
Qualification: Life Science Degree or Allied Health Certification (or equivalent experience)
Salary Range: Not Specified
Job Overview
The company is hiring a Director, Clinical Operations responsible for leading clinical operations strategy, overseeing clinical trial execution, and driving business growth within Clinical Pharmacology Services.
The role involves managing clinical study portfolios, building client relationships, ensuring operational excellence, and leading cross-functional teams to deliver high-quality clinical research outcomes in compliance with global regulatory standards.
Key Responsibilities
Clinical Operations Leadership
Oversee execution of clinical trials across multiple programs and therapeutic areas.
Manage study portfolios ensuring quality, timelines, and compliance.
Provide strategic direction for operational delivery and study execution.
Business Growth & Strategy
Drive business growth through innovative clinical trial solutions.
Develop and maintain strategic client relationships.
Support proposal development and costing strategies.
Client & Stakeholder Management
Own client expectations and ensure high satisfaction levels.
Build and maintain relationships with sponsors and vendors.
Act as senior-level contact for operational and strategic discussions.
Team Leadership & People Management
Lead, mentor, and develop high-performing teams.
Drive talent development, succession planning, and staff retention.
Ensure effective training and performance management of staff.
Operational Excellence & Quality
Ensure compliance with ICH-GCP and regulatory requirements.
Oversee monitoring activities including site initiation, monitoring, and closeout.
Ensure timely delivery of study outputs and adherence to protocols.
Risk Management & Compliance
Identify and resolve operational and compliance issues.
Ensure proper escalation of quality and compliance risks.
Lead CAPA implementation and quality improvement initiatives.
Financial & Resource Management
Monitor program profitability and financial performance.
Manage resource allocation and utilization across projects.
Support budgeting, forecasting, and cost control activities.
Process Improvement & Innovation
Drive continuous improvement in clinical operations processes.
Develop and implement standardized tools and methodologies.
Lead strategic initiatives to improve efficiency and productivity.
Required Skills
Clinical Operations & Research Expertise
Strong understanding of clinical trial execution and monitoring activities.
Knowledge of drug development lifecycle and clinical research processes.
Experience in managing large-scale clinical programs.
Regulatory & Compliance Knowledge
Strong knowledge of ICH-GCP and global regulatory requirements.
Understanding of SOPs, clinical quality standards, and compliance frameworks.
Leadership & Communication
Strong leadership and team management skills.
Excellent stakeholder engagement and communication abilities.
Ability to influence and lead in a matrix environment.
Analytical & Decision Making
Strong problem-solving and strategic thinking skills.
Ability to manage risks, conflicts, and operational challenges.
Financial & Operational Skills
Experience in budgeting, costing, and financial management.
Ability to manage multiple projects and resources efficiently.
Preferred Qualifications
Experience in Clinical Pharmacology Services or early phase trials.
Experience working in CRO or pharmaceutical environments.
Strong exposure to global clinical operations and client management.
Key Competencies
Clinical operations leadership and execution
Strategic planning and business growth
Regulatory compliance and quality management
Stakeholder and client relationship management
Financial and resource management
Team leadership and talent development
About the Company
Not Specified
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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