Summary
Overview
Work History
Education
Skills
Timeline
Generic

Calista Gauthier

Shrewsbury,MA

Summary

Twenty-plus years of clinical research experience in a variety of therapeutic areas in phase 1-4 global studies. Experienced in working on pivotal studies spanning from study concept to submission, with focus on delivering high-quality data within aggressive timelines. Skilled in providing strategic leadership at the study and program levels, as well as effectively collaborating with key stakeholders to achieve study/program deliverables.

Overview

27
27
years of professional experience

Work History

Clinical Operations Program Lead, Senior Manager

Takeda Pharmaceuticals
11.2023 - 08.2025
  • Company Overview: Therapeutic experience includes Phase II and III Rare Disease and GI clinical studies
  • Provide operational expertise and strategic input to the development of Clinical Development Plans (CDP) supporting the overall clinical strategy for one or more clinical programs
  • Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with strategic partners and other vendors
  • Provide program-level operational oversight of strategic partners and other vendors to ensure the effective execution of the clinical studies on time, in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), within the agreed budget, and on schedule
  • Collaborate with Clinical Operations Managers (COMs) and cross-functional counterparts to oversee the performance for all activities assigned to our strategic partners/other CROs/other vendors, including escalation of issues to governance committees and to senior management when warranted
  • Responsible for clinical program budget planning and accountable for external spend related to clinical program execution. Works closely with COMs, Global Program Management (GPM), Outsourcing Management, and Finance to ensure that budgets, enrollment, and gaiting are accurate
  • Communicate program status, cost and issues to ensure timely decision-making by senior management
  • Provide program-level direction, guidance and support to the COM in development of study strategy operational plans, including enrollment models and risk management strategy
  • Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis & protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2, Request for Scientific Advice Meetings, etc.), as appropriate
  • Collaborate with COMs, Strategic Partners/other CROs/other vendors to ensure inspection readiness
  • Serve as the point of escalation for the Clinical Operations Managers for issues that cannot be resolved at the study level


Senior Clinical Operations Manager/Clinical Operations Manager

Takeda Pharmaceuticals/Shire Pharmaceuticals
04.2016 - 11.2023
  • Company Overview: Takeda acquired Shire in 2019; Therapeutic experience includes Phase II and III Rare Disease and GI clinical studies
  • Led study operational strategy, planning, and oversaw execution of global clinical studies
  • Oversaw the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs)
  • Oversaw Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and business objectives
  • Provided subject matter expertise and operational input into protocol synopsis, final protocol and other study-related documents
  • Validated budgets and ensured impact was adequately addressed. Responsible for study budget planning and management, and accountable for external spend related to study execution
  • Participated in country and site feasibility/selection process to ensure alignment between study execution plan and program strategy
  • Oversaw Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted
  • Reviewed outcomes/actions related to protocol deviations review to support the identification of trends across sites and/or the study
  • Documented review and monitoring of issues, risks and decisions at the study level, and implementation of appropriate mitigation strategies
  • In partnership with data management, reviewed and pressure tested all database timelines and plans; ensured strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR
  • Ensured studies are 'inspection ready' at all times
  • Prepared for and participated in health authority regulatory inspections and mock-inspections as the Clinical Operations study representative

Clinical Programs Scientist

Shire Pharmaceuticals
01.2014 - 04.2016
  • Managed the planning, implementation, and execution of clinical research studies
  • Managed clinical outsourcing to CROs and other vendors such as IVRS, labs, IRBs, etc.
  • Authored, reviewed, and approved various study-related documents and plans
  • Led cross-functional teams and was responsible for the oversight and management of study timelines as well as the financial management of a study
  • Ensured new team members and vendors were appropriately onboarded. Assisted with onboarding/mentoring of new or junior COMs.

Senior Clinical Research Associate

ViroPharma Incorporated
12.2011 - 01.2014
  • Company Overview: Shire acquired ViroPharma in 2014. Therapeutic experience includes Phase II and III Rare Disease clinical studies
  • Provided in-house support during study start-up, conduct, and close-out of investigational studies
  • Contributed to protocol development activities
  • Performed site selection activities including development of applicable site selection documentation (e.g., feasibility questionnaire) and liaising with sites to execute confidentiality agreements
  • Generated and developed study-specific forms, tools, and or processes (e.g., Informed Consent templates, Regulatory Binders, and Monitoring Plans, etc.) in collaboration with the Clinical Operations Manager, and Clinical Trial Assistant as applicable
  • Supported sites selected for study participation in the preparation for drug shipment by assisting with IRB/IEC submissions, regulatory document collection and review, budget and contract negotiations in collaboration with the Clinical Operations Manager and Legal
  • Coordinated entry of required study information in the clinical trial management system
  • Contributed to study team decisions and escalated study conduct issues as applicable
  • Assisted in case report form development and user acceptance testing
  • Assisted field-based team with data query, SAE/AE, laboratory and archive reconciliation activities
  • Reviewed site monitoring reports from study monitors for quality, accuracy, and completeness
  • Generated and maintained study files in collaboration with Archives and according to Standard Operating Procedures
  • Contributed to resolution of issues raised by investigative site and internal Quality Assurance audits
  • Processed investigator grant payments
  • Supported the Clinical Operations Manager to manage clinical vendors
  • Contributed to review of Standard Operating Procedures


Clinical Research Associate II

PRA International
09.2010 - 11.2011
  • Company Overview: Therapeutic experience includes Phase I and II Oncology clinical trials
  • Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines
  • Monitored sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, review data, and ensure accuracy of data collected, and to terminate studies
  • Provided clinical status information to team members and project management
  • Worked within PRA systems to track site metrics
  • Performed billable work in accordance with PRA policies, procedures, and Standard Operating Procedures (SOPs)
  • Worked closely with other team members to ensure timely resolution of project and/or clinical issues
  • Communicated common site trends to Lead CRA and other project team members
  • Performed investigative site file reconciliation
  • Requested new or updated site regulatory documents and review them for content, consistency, and compliance with ICH guidelines, project SOPs, and sponsor requirements
  • Performed 100% source document verification of Case Report Forms (CRFs), and perform query resolution in a timely manner
  • Worked with study vendors to ensure site study deliverables are met
  • Oversaw drug accountability and reconciliation at investigative sites
  • Ensured Serious Adverse Event (SAE) reporting according to project specifications
  • Supported and responded to requests from investigative sites in a timely fashion


Clinical Research Associate

Luitpold Pharmaceutical, Inc.
09.2009 - 09.2010
  • Company Overview: Therapeutic experience includes Phase III Renal and Anemia clinical trials
  • Conducted monitoring of multiple sites, including site initiations, interim visits, and closeout visits
  • Responsible for the management of clinical sites and vendors
  • Responsible for 100% source verification of CRFs for all subjects across multiple sites
  • Managed sites to ensure query resolution and SAE reconciliation
  • Generated manual queries to clarify challenging data
  • Monitored and tracked site drug shipments and subject specific drug accountability
  • Reviewed site informed consents for regulatory and EC/IRB approval
  • Responsible for the ongoing review of site regulatory documents and EC/IRB approvals for submission to the Trial Master File
  • Updated and maintained study specific databases
  • Participated in the review and drafting of protocol amendments, ICFs, and study specific documents
  • Participated in the training and mentoring of new study monitors


Clinical Development Associate II

Gemin X Pharmaceuticals, Inc.
04.2007 - 04.2009
  • Company Overview: Therapeutic experience includes Phase I and II clinical trials in Oncology
  • Lead in the drafting, review and revision of study documents including Case Report Forms, CRF Completion Guidelines, and Informed Consent templates
  • Assisted in the drafting, review, and revision of study protocols, safety update reports, pharmacy manuals, laboratory manuals, etc.
  • Developed training materials and participated in the training of new study monitors
  • Developed site training presentations/materials
  • Monitored study sites as applicable (Pre-Study, Initiation, Interim and Close-out Visits)
  • Monitored the study conduct and progress across study sites in conjunction with the contract monitors
  • Initiated the regulatory process at study sites and lead in the collection and review of site regulatory documents for study initiation
  • Reviewed site informed consents for regulatory approval
  • Coordinated with the Contracts and Budgets Administrator for the completion of site contracts and budgets
  • Conducted site feasibility for potential study participation
  • Reviewed site monitoring visit reports from study monitors for quality, accuracy, and completeness
  • Coordinated with sites and contract monitors to perform CRF retrieval, query resolution, and SAE reconciliation activities
  • Managed and supported contract monitors
  • Contributed in the development and implementation of plans associated with site audits, providing link between Clinical Development and Quality Assurance
  • Managed clinical supplies and supply vendors across several studies
  • Supported Clinical Development Managers to manage clinical vendors
  • Coordinated with Regulatory Department in the distribution of safety updates to sites
  • Coordinated with clinical team members to streamline clinical processes

Clinical Research Assistant

Genaera Corporation
07.2005 - 01.2007
  • Company Overview: Therapeutic experience includes Phase II and III clinical trials in Oncology, Ophthalmology and Cystic Fibrosis
  • Reviewed site monitoring visit reports from CROs for accuracy and completeness
  • Conducted site closeout visits and study drug accountability/return in accordance with company SOPs
  • Lead in the collection and review of regulatory documents, including informed consents for Regulatory approval
  • Processed and tracked Investigator and vendor payments
  • Participated in CRO project oversight activities including tracking site and project specific activities and meeting participation
  • Developed tracking tools to assist in the collection and organization of study data and information
  • Generated and/or assembled study documents, newsletters, binders and correspondence for distribution to study sites and EC/IRBs, including IND Safety Reports
  • Maintained internal study-specific Trial Master Files and reconciled study files from CROs in accordance with company SOPs
  • Participated in the development and review of Standard Operating Procedures, Working Practice Guidelines, and Clinical Policy documents
  • Participated in the planning and coordination of training meetings (Internal training, Investigator meetings, Study Coordinator and Vendor training)
  • Oversaw management of study vendors
  • Follow-up with sites regarding study issues as needed
  • Participated in the orientation and training of new Clinical employees
  • Provided additional administrative support to Clinical Operations and Data Management Departments

Clinical Project Assistant/Senior Technical Assistant

PharmaNet, Inc.
11.1998 - 07.2005
  • Company Overview: Experience with Phase II through IV clinical trials in various therapeutic areas including Type II Diabetes, Wound Healing, Alcohol Dependence, Neuroscience, COPD, and HIV
  • Set up and maintained project files and investigator files
  • Distributed and obtained regulatory and administrative documents for investigational sites
  • Reviewed regulatory documents for study sites, including informed consents
  • Submitted site regulatory packages to central IRBs
  • Contacted study personnel at sites for administrative issues
  • Conducted site feasibility surveys and reports
  • Prepared study newsletters and Client/Team meeting minutes for multiple studies
  • Generated and maintained project related spreadsheets and documents
  • Prepared contracts and processed payments to investigative sites
  • Performed in-house review and verification of Case Report Forms and Data Clarification Forms
  • Shipped supplies and documents to Client, Investigator sites, and EC/IRBs
  • Assembled materials and binders for Investigator Meetings
  • Prepared regulatory binders for study sites
  • Maintained study specific project reports
  • Maintained company’s web-based electronic data capture system for specific studies
  • Fielded Investigator phone calls and issues
  • Oversaw management of study vendors
  • Maintained PharmaNet Investigator Databank
  • Scanned regulatory documents for electronic files
  • Assisted in the monitoring of investigative sites
  • Provided training for new Technical Assistants on job functions and company SOPs
  • Provided clerical and administrative support to project teams

Education

Biology Major

Rutgers University
New Brunswick, NJ

Biology Major

Mercer County Community College
West Windsor, NJ

Skills

  • Strategic planning
  • Cross-functional collaboration
  • Operations management
  • Cross-functional team coordination
  • Budget oversight
  • Troubleshooting and problem resolution

Timeline

Clinical Operations Program Lead, Senior Manager

Takeda Pharmaceuticals
11.2023 - 08.2025

Senior Clinical Operations Manager/Clinical Operations Manager

Takeda Pharmaceuticals/Shire Pharmaceuticals
04.2016 - 11.2023

Clinical Programs Scientist

Shire Pharmaceuticals
01.2014 - 04.2016

Senior Clinical Research Associate

ViroPharma Incorporated
12.2011 - 01.2014

Clinical Research Associate II

PRA International
09.2010 - 11.2011

Clinical Research Associate

Luitpold Pharmaceutical, Inc.
09.2009 - 09.2010

Clinical Development Associate II

Gemin X Pharmaceuticals, Inc.
04.2007 - 04.2009

Clinical Research Assistant

Genaera Corporation
07.2005 - 01.2007

Clinical Project Assistant/Senior Technical Assistant

PharmaNet, Inc.
11.1998 - 07.2005

Biology Major

Mercer County Community College

Biology Major

Rutgers University

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