# Charlotte Quaratino-Baker Charlotte Quaratino-Baker is a remote worker on Himalayas, Associate Director, Clinical Development at IGM Biosciences, based in Zimbabwe. Source: https://himalayas.app/@charlottequaratinoba ```text Experienced Associate Director in Clinical Development and Operations. ``` | Detail | Value | | --- | --- | | Availability | Open to opportunities | | Location | Zimbabwe | | Authorized to work in | Zimbabwe | | Job categories | Associate Director Of Medical Affairs | | Skills | Clinical Development Plans, Project Management, Clinical Trials, Regulatory Compliance, Vendor Management, Data Review Tools, Risk Management, Team Leadership, Oncology, .NET | ## What I'm looking for ```text I seek a role that fosters collaboration, innovation, and professional growth in clinical research. ``` ## About ```text 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 ### Associate Director, Clinical Development (current) IGM Biosciences. Nov 2023 - Present ```text 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. ``` Skills: Clinical-Site-Management, Vendor-Management, Budget-Management, GCP, Clinical-Study ### Associate Director/Director, Clinical Operations Heron Therapeutics. Dec 2021 - Oct 2023 ```text 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. ``` Skills: CRO, Vendor-Selection, GCP ### Associate Clinical Trial Manager Director, Oncology IQVIA Biotech/Novella Clinical. Apr 2021 - Nov 2021 ```text 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. ``` Skills: GCP, Team-Management, Project-Management, Client-Management, Training, SOPs, Mentorship ### Senior Clinical Trial Manager IQVIA Biotech/Novella Clinical. Jan 2015 - Apr 2021 ```text 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. ``` Skills: Clinical-Monitoring-Plan, Regulatory-Document-Collection, Monitoring ### Regional Clinical Trial Monitor/Lead Clinical Trial Monitor Genentech, Inc.. Jan 2008 - Jan 2015 ```text 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. ``` Skills: Monitoring, Site-Oversight ### Clinical Lead/Project Manager PAREXEL, International Corporation. Jan 2006 - Dec 2008 ```text Served as a Clinical Lead and Project Manager. Responsibilities included overseeing clinical trial activities and managing project timelines and resources. ``` Skills: Clinical-Leadership, Project-Management, Resource-Management ### Program Manager/Sr. CRA OSI Pharmaceuticals, Inc.. Jan 2002 - Dec 2006 ```text Held roles as Program Manager/Sr. CRA and CRA II. Involved in managing clinical trial programs and performing clinical research associate duties. ``` Skills: Program-Management, Clinical-Research-Associate, Data-Collection ### CRA II OSI Pharmaceuticals, Inc.. Jan 1999 - Dec 2002 ```text Worked as a Clinical Research Associate II. Responsibilities included monitoring clinical trial sites and ensuring data integrity. ``` Skills: Clinical-Research-Associate, Monitoring, Data-Integrity, Clinical-Trials ### Assistant Project Manager/Quality Control Manager Pharmatech, Inc.. Jan 1997 - Dec 1998 ```text 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. ``` Skills: Project-Management, Quality-Control, Monitoring ### Sr. Clinical Research Coordinator/QC Monitor Pharmatech, Inc.. Jan 1996 - Dec 1997 ```text Worked as a Senior Clinical Research Coordinator/QC Monitor. Responsibilities included coordinating clinical research activities and performing quality control monitoring. ``` Skills: Quality-Control, Clinical-Trials ### Clinical Research Coordinator National Jewish Center. Jan 1992 - Dec 1996 ```text Served as a Clinical Research Coordinator. Involved in coordinating clinical research studies and managing study data. ``` Skills: Clinical-Trials ## Education ### Fort Lewis College Bachelor of Science, Biology ```text Completed a Bachelor of Science degree with a focus on biological studies. Gained foundational knowledge in various areas of biology. ``` ## Tech stack - .NET To contact Charlotte, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire). ## People also viewed - [Tamara Jones](https://himalayas.app/@tamarajones): Operations Manager, ProElite Family Logistics LLC - [Basundhara Bansal](https://himalayas.app/@basundharabansal): Clinical Trail Manager & Research Associate, Lifespark Technologies Pvt. 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