Open to opportunities

Charlotte Quaratino-Baker

@charlottequaratinoba

Message

Experienced Associate Director in Clinical Development and Operations.

Zimbabwe

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What I'm looking for

I seek a role that fosters collaboration, innovation, and professional growth in clinical research.

I am an accomplished Associate Director in Clinical Development with extensive experience managing global clinical trials across various therapeutic areas, including oncology and autoimmune diseases. My career spans over two decades, during which I have successfully led multiple clinical studies, ensuring adherence to regulatory standards and delivering high-quality results.

At IGM Biosciences, I independently manage multiple global clinical trials, overseeing all aspects from operational planning to vendor management. My proactive approach in identifying project risks and maintaining communication with CROs has consistently resulted in successful trial outcomes. I am passionate about advancing clinical research and improving patient outcomes through rigorous study management and collaboration with cross-functional teams.

Experience

Work history, roles, and key accomplishments

Current

Associate Director, Clinical Development

Current

IGM Biosciences

Nov 2023 - Present (1 year 6 months)

Independently manages multiple global clinical trials, overseeing sites and vendor-related issues, including CROs. Manages study operational plans, timelines, budgets, and contributes to study documentation like protocols and reports.

Clinical Site Management Vendor Management Budget Management GCP Clinical Study

Associate Director/Director, Clinical Operations

Heron Therapeutics

Dec 2021 - Oct 2023 (1 year 10 months)

Managed CRO activities, including project timelines and quality deliverables. Led the selection of study vendors and investigational sites. Contributed to study documentation and assisted with timeline development.

CRO Vendor Selection GCP

Associate Clinical Trial Manager Director, Oncology

IQVIA Biotech/Novella Clinical

Apr 2021 - Nov 2021 (7 months)

Responsible for planning, implementation, and execution of contracted clinical monitoring activities. Functionally responsible for clinical monitoring team members and ensuring compliance with GCP and procedures. Served as global/program CTM coordinating and overseeing a project team of regional CTMs.

GCP Team Management Project Management Client Management Mentoring Training SOPs

Senior Clinical Trial Manager

IQVIA Biotech/Novella Clinical

Jan 2015 - Apr 2021 (6 years 3 months)

Responsible for all activities related to implementation and execution of clinical studies. Defined program targets for clinical monitoring staff and assured documentation within scope. Served as client advocate and developed/implemented Clinical Monitoring Plans.

Clinical Monitoring Plan Regulatory Document Collection Monitoring

Regional Clinical Trial Monitor/Lead Clinical Trial Monitor

Genentech, Inc.

Jan 2008 - Jan 2015 (7 years)

Independently coordinated and performed the evaluation, initiation, monitoring, and closeout of sites. Performed training, management, and oversight of investigative sites. Developed site relationships, secured/maintained essential documents, and verified source against CRFs.

Monitoring Site Oversight

Clinical Lead/Project Manager

PAREXEL, International Corporation

Jan 2006 - Dec 2008 (2 years 11 months)

Served as a Clinical Lead and Project Manager. Responsibilities included overseeing clinical trial activities and managing project timelines and resources.

Clinical Leadership Project Management Resource Management

Program Manager/Sr. CRA

OSI Pharmaceuticals, Inc.

Jan 2002 - Dec 2006 (4 years 11 months)

Held roles as Program Manager/Sr. CRA and CRA II. Involved in managing clinical trial programs and performing clinical research associate duties.

Program Management Clinical Research Associate Data Collection

CRA II

OSI Pharmaceuticals, Inc.

Jan 1999 - Dec 2002 (3 years 11 months)

Worked as a Clinical Research Associate II. Responsibilities included monitoring clinical trial sites and ensuring data integrity.

Clinical Research Associate Monitoring Data Integrity Clinical Trials

Assistant Project Manager/Quality Control Manager

Pharmatech, Inc.

Jan 1997 - Dec 1998 (1 year 11 months)

Held roles as Assistant Project Manager/Quality Control Manager and Sr. Clinical Research Coordinator/QC Monitor. Involved in project management, quality control, and clinical research coordination.

Project Management Quality Control Monitoring

Sr. Clinical Research Coordinator/QC Monitor

Pharmatech, Inc.

Jan 1996 - Dec 1997 (1 year 11 months)

Worked as a Senior Clinical Research Coordinator/QC Monitor. Responsibilities included coordinating clinical research activities and performing quality control monitoring.

Quality Control Clinical Trials