Open to opportunities

April Balousek

@aprilbalousek

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Senior management professional driving operational excellence in clinical research.

United States

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What I'm looking for

I am looking for a role that fosters collaboration, innovation, and career growth.

I am a senior management professional with extensive experience in clinical operations and project management. My career has been dedicated to driving organizational success through strategic leadership and operational excellence. I have a proven track record of managing high-performing teams, optimizing processes, and navigating complex challenges in the clinical research landscape.

Throughout my career, I have successfully led cross-functional teams to achieve project milestones and deliver high-quality results. My role as Senior Manager of Research Services at ICON plc has allowed me to develop and implement strategic plans, manage resources effectively, and foster a culture of accountability. I am passionate about mentoring and developing talent, ensuring that my teams are equipped to meet the evolving needs of our clients.

With a strong focus on compliance and quality, I have contributed to the successful execution of numerous clinical trials across various therapeutic areas. My expertise in FDA regulations, clinical trial management, and vendor management has been instrumental in delivering positive patient and investigative site experiences. I am committed to continuous improvement and look forward to leveraging my skills to drive success in future endeavors.

Experience

Work history, roles, and key accomplishments

Current

Senior Manager of Research Services, Real World Solutions

Current

ICON plc

Apr 2024 - Present (1 year 2 months)

Responsible for direct line management of a team of Clinical Trial Managers and Sr. Clinical Trial Managers in North America. Developed existing team of CTMs into high productivity, results-oriented unit through creative initiatives.

Project Management Strategic Planning Team Leadership Process Improvement Performance Metrics

Manager of Clinical Operations, Real World Solutions

ICON plc

Apr 2021 - Apr 2024 (3 years)

Responsible for direct line management and development of Clinical Trial Managers and Site Management Associates. Managed the performance of Clinical Trial Managers and Site Management Associates, including providing input into salaries, bonuses as well as nominations for promotion.

Resource Management Performance Management ICH GCP SOPs Process Development Change Management Clinical Site Management

Clinical Trial Manager, Real World Solutions

PRA Health Sciences

Nov 2018 - Apr 2021 (2 years 5 months)

Managed all study site related activities in a project with a low to medium complexity. Served as primary liaison for the client for all site related issues, including but not limited to site management and applicable clinical monitoring issues, escalating as required.

Project Planning Communication Reporting Training Budget Management

Associate Director, Clinical Trial Management

NSABP Foundation, Inc.

Feb 2013 - Nov 2018 (5 years 9 months)

Provided strategic clinical operations oversight and direction ensuring collaboration across projects. Led, influenced and cross functionally managed large complex and/or multiple small studies to deliver positive patient and investigative site experiences and high-quality data.

Project Management Risk Management Budget Oversight Vendor Selection Team Leadership

Clinical Operations Manager

NSABP Foundation, Inc.

Nov 2009 - Feb 2013 (3 years 3 months)

Assisted with planning, managing and executing multicenter Phase I, II and III breast and colorectal cancer clinical trials. Designed and implemented remote monitoring program, on-site monitoring program and risked based monitoring program.

Clinical Trials Project Management Monitoring Risk Management Data Management SOPs EDC

Clinical Trial Manager

NSABP Foundation, Inc.

Jun 2005 - Nov 2009 (4 years 5 months)

Responsible for coordinating and centrally monitoring multicenter Phase I, II and III breast and colorectal cancer clinical trials. Responsible for site start up activities to ensure all sites are enrollment ready within study specific time frames.

Clinical Trials

Clinical Research Coordinator

University of Pittsburgh Medical Center

Oct 2004 - Jun 2005 (8 months)

Worked as a Clinical Trials Research Nurse Clinician. Involved in clinical trial research activities.

Clinical Trials Patient Care Data Collection

Clinical Trials Research Nurse Clinician

University Health Associates, Clinical Trials Research Unit

May 2003 - Oct 2004 (1 year 5 months)

Functioned as a Clinical Trials Research Nurse Clinician. Participated in clinical trial research within the unit.

Clinical Trials Patient Care Data Collection

Research Nurse Orthopedic Surgery

University Health Associates

Dec 2002 - May 2003 (5 months)

Served as a Research Nurse in Orthopedic Surgery. Involved in research activities related to orthopedic surgery.

Patient Care Data Collection Medical Research

Education

Degrees, certifications, and relevant coursework

Pennsylvania State University

Bachelor of Science, Nursing

Completed a Bachelor of Science degree with a focus on Nursing. Gained foundational knowledge and practical skills essential for a career in healthcare.