Clinical Research Operations

LEANDRA MACK, MS

Saint Johns, FL *****

*******.****@*******.*** 904-***-****

LinkedIn profile: www.linkedin.com/in/leandra-mack-5b182b1bb SUMMARY

Seasoned Clinical Operations Professional with over 15 years of distinguished career leading large-scale pharmaceutical and medical device clinical trials and operational teams across high-impact therapeutic areas, including but not limited to Oncology, Cardiology, CNS, and Rare Diseases. Demonstrates a robust track record in managing cross-functional teams, optimizing protocol and regulatory compliance, and advancing process improvements that enhance operational efficiency and drive clinical success. Known for building and mentoring high-performing teams, cultivating a culture of excellence in customer service, and establishing strong partnerships with global clients and stakeholders to achieve clinical and business objectives. Deep expertise in Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Workday, regulatory navigation, strategic resource, FTE allocation, performance management, and aligning clinical operations with organizational goals to deliver sustained growth and value. Six years of experience as a Clinical Research Coordinator (2003-2009), Cardiology/ Hematology/ Oncology, specific location available upon request. CORE SKILLS

Clinical Operations Leadership Performance & Quality Management Regulatory Compliance Project Management Stakeholder & Client Collaboration Resource Allocation Team Management Process Improvement Protocol Compliance In-House/ Field Site Monitoring Risk Management Strategic Resource Planning Process Optimization

Cross-functional Team Leadership Clinical Data Integrity & Analysis Quality Assurance & Auditing Regulatory Affairs

& Submissions Workday Planning

CLINICAL RESEARCH THERAPEUTIC AREAS

Ophthalmology: Diabetic Macular Edema Dermatology: Plaque Psoriasis Oncology: HER2 Positive Mutated Breast Cancer TnMUC1 Positive Advanced Cancer Cardiology: High Cholesterol and Clinically Evident Cardiovascular Disease CNS: Prodromal to Mild Alzheimer’s Disease Rare Diseases: Systemic Sclerosis PROFESSIONAL EXPERIENCE

ICON CLINICAL RESEARCH

Manager, Clinical Operations May 2023 –November 2024

• People Leadership: Serve as a dedicated leader for the local Clinical Operations team, overseeing CRAs (Clinical Research Associates and CTMs (Clinical Trial Managers) teams based on size and needs.

• Performance Evaluation: Conduct Assessment Visits (ASV) to evaluate team performance and guide professional development, ensuring adherence to quality and regulatory standards.

• High-Performance Culture: Foster a high-performing team environment by managing attrition, supporting skill development, and driving employee engagement within the operational group.

• Comprehensive Leadership: Handle all aspects of People Leadership, including performance reviews, goal setting, resource allocation, talent acquisition, and development planning.

• Team Empowerment and Coaching: Empower and coach the local clinical operations team to achieve their objectives, improving efficiency and ensuring alignment with organizational goals. ICON CLINICAL RESEARCH (AMGEN)

Manager, Clinical Operations September 2021 – May 2023

• Training & Compliance: Ensured FSP staff were thoroughly trained and maintained adherence to SOPs, policies, and regulatory guidelines, upholding high standards for quality compliance.

• People Leadership & Development: Acted as the dedicated People Leader for the local Clinical

• Operations team, including Clinical Trial Managers (CTMs).

• Performance Management: Oversaw all aspects of performance management, goal setting, resource allocation, talent acquisition, and staff development through coaching and mentoring.

• Study Assignments & Objective Support: Coordinated study and site assignments in collaboration with the Amgen team, providing support to FSP staff to meet study timelines, deliverables, and overall objectives.

• Operational Reporting: Maintained continuous communication with Amgen management, providing regular feedback on FSP staff operations.

• Client Liaison: Acted as the primary contact for Amgen's CPS-SM, ITL, PRM, and study leads, ensuring seamless collaboration.

• Performance & Process Improvement: Analyzed team performance metrics to identify areas for

• improvement, implementing strategies to enhance efficiency and operational effectiveness. IQVIA (Eli Lilly) November 2020 – September 2021

Dedicated Line Manager

• Clinical Operations Leadership: Served as the dedicated leader for the local Clinical Operations team, including Clinical Research Associates (CRAs), aligning with team size and country-specific structure.

• Resource Allocation & Workload Management: Directed resource allocation, managed workload assignments, and provided clear guidance for CRAs to ensure effective study execution.

• Assessment Visits & Development: Conducted Assessment Visits (ASVs) to guide professional development, support onboarding, and enhance the skillsets of direct reports.

• Quality & Compliance Monitoring: Identified quality risks and issues, developing corrective action plans to address or prevent performance deficiencies.

• Performance & Metrics Management: Regularly reviewed workload and quality metrics to confirm that staff met defined targets, reporting findings to Clinical Operations Management to ensure ongoing quality and productivity. IQVIA (Roche) October 2019 – November 2020

Project Management

• Leadership & Team Development: Led and provided direction to a team of 90-120 Clinical Research Associates

(CRAs), overseeing their training and development in the implementation of the Shared Investigator Platform

(SIP) across multiple sites and institutions.

• Stakeholder Engagement: Collaborated with cross-functional teams and stakeholders to ensure

• alignment of SIP implementation with organizational and regulatory requirements, fostering effective communication throughout the project lifecycle.

• Performance Monitoring & Reporting: Monitored project performance, tracking key metrics, and provided regular status updates to senior management and stakeholders on project progress and outcomes. IQVIA (Roche) June 2016 – October 2019

Senior Clinical Research Associate

• Site Management & Monitoring: Conducted Site Initiation Visits (SIV), Onsite and Remote Monitoring, Interim Monitoring (IMV), and Close Out Visits (COV), ensuring the smooth operation of clinical trials.

• Regulatory Compliance & Submissions: Ensured protocol and drug compliance, managed IRB submissions, and prepared regulatory documentation, including informed consent and protocol drafting.

• Clinical Trial Oversight: Managed Phase II-IV clinical studies, ensuring adherence to ICH-GCP guidelines and applicable regulations to maintain high-quality standards.

• Mentorship & Training: Provided mentorship to new hires, fostering skill development and promoting team growth through knowledge transfer and training.

Johnson & Johnson Vision Care (Vistakon) – Jacksonville, FL June 2012 – May 2015 Senior Clinical Research Associate

• Site Management & Monitoring: Conducted Site Initiation Visits (SIV), Onsite and Remote Monitoring, Interim Monitoring (IMV), and Close Out Visits (COV), ensuring the smooth operation of clinical trials, Ophthalmology/ Medical Device.

• Regulatory Compliance & Submissions: Ensured protocol and drug compliance, managed IRB submissions, and prepared regulatory documentation, including informed consent and protocol drafting.

• Clinical Trial Oversight: Managed Phase II-IV clinical studies, ensuring adherence to ICH-GCP guidelines and applicable regulations to maintain high-quality standards.

• Mentorship & Training: Provided mentorship to new hires, fostering skill development and promoting team growth through knowledge transfer and training.

EDUCATION

Capella University Master of Science – Specialization in Child and Adolescent Development University of North Florida Bachelor of Arts in Psychology CERTIFICATION

Certified Clinical Research Professional (CCRP) Society of Clinical Research Associates (SOCRA) 2004-2007

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