AMANDA CONCANNON
Boston,MA
Summary
Expertise in clinical trial management, regulatory compliance, and cross-functional team leadership. Adept at strategic planning, risk management, and fostering effective communication among stakeholders.
Overview
11
11
years of professional experience
Work History
Senior Clinical Project Manager, Clinical Operations- Phase 3 experience in Rare Disease
Novo Nordisk Inc.
03.2024 - 10.2025
- Oversees performance of CROs, third party vendors, and contractors to ensure compliance with study protocol and identifying areas of concern and escalating to Clinical Program Lead when appropriate
- Collaborates with the Clinical Program Lead and study team to develop patient recruitment strategies, operational feasibility, and implementation of study objectives
- Develops study plans including key milestones and timelines
- Ensures country and site selection meets study requirements
- Participates in the development and testing of clinical systems (e.g., data capture, IxRS)
- Ensures internal and external systems are updated in a timely manner (e.g., trackers, clinicaltrials.gov)
- Manages critical study documents such as consent forms, study manuals, subject recruitment materials
- Oversees the Trial Master File (TMF) and assists with periodic audits of the TMF
- Drives critical clinical trial activities including trial site activations, recruitment, and database lock
- Assists in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting
- Independently manages interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally
- Participates in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points
- Collaborates with other functions (at CRO or internally) to ensure robust plans for study level data review including trend evaluation
- Provides input in internal/external study related audits including review resulting reports
- Reviews monitoring reports and if applicable, corrective action plans at individual sites and provides oversight to ensure safety concerns are identified and responses developed
- Communicates trial status, issues, and mitigations to relevant cross-functional stakeholders
- Trains study team members, external monitors, and site staff as needed
Senior Manager, Project Management, R&D Implementation Office
Takeda Pharmaceutical Company Limited
07.2022 - 03.2024
- Provided support and technical expertise for high-priority, cross-functional activities for Study Operationalization and guided the implementation across the organization as well as to identify risks and mitigations for overall success
- Partnered with functions involved in Study Operationalization and other platform teams (HR, Procurement, Finance) to establish relevant team structures, charters, and processes for value demonstration
- Served as business process support for workstream decisions and connectivity to other workstreams
- Managed plans / information in different applications and systems (i.e., Airtable, SharePoint) to support workplans
- Supported workstream by being contact point between leads and other stakeholders
- Ensured all aspects of the project are planned and executed in line with goals, timeline, and budget
- Ensured deliverables are progressing according to specifications and completed on time
- Identified and assessed risks with significant business impact and ensures milestone achievement across cross-functional teams
- Identified interdependencies and ensured connections are made across other workstreams and platform teams
- Proactively identified potential issues or obstacles and plans contingencies
- Followed issued through to resolution ensuring that all key stakeholders were informed of outcomes and implications
- Developed and prepared key communications and strategies to strengthen and support change management efforts
- Partnered with the Workstream Lead to shape strategy and execution of overall workstream
- Proactively managed key stakeholders and facilitated relevant communications to appropriate teams, functions
- Managed 12 sub-streams of various Clinical Operations facets
Clinical Project Manager - Phases 1 and 2 experience in Infectious Disease
Spero Therapeutics
04.2020 - 05.2022
- Planned and implemented Phase 1 and Phase 2 anti-infective clinical research studies
- Generated timelines and updated necessary stakeholders on progress toward milestones
- Led and worked within cross-functional project teams, including defining objectives and deliverables, building, and maintaining project plans, and resource and budget management
- Participated in site, CRO, and vendor selection and management
- Implemented oversight of vendors in accordance with SOPs, ICH guidelines, and Good Clinical Practice
- Provided input to Clinical Study Reports including data cleaning, listing review, and report writing
- Developed standard operating procedures (SOPs), work instructions (WIs), and standardized forms for various Clinical Operations activities
- Collaborated with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP
- Reviewed and negotiated contracts
- Managed budgets for studies - accruals and forecasts
Senior Clinical Research Coordinator - Phases 1, 2, and 3 experience in CNS
Sage Therapeutics
08.2017 - 04.2020
- Engaged with KOLs and Advocacy Groups for program planning
- Organized and facilitated Protocol Development Meetings
- Designed and implemented a trial enrollment tracking process
- Represented Clinical Operations at various educational and advocacy group
- Drafted informed consent forms
- Reviewed monitoring visit reports
- Assisted in start-up activities of clinical research studies including enrollment planning and investigator/site selection
- Updated weekly program dashboard with enrollment metrics, budget information, and other study metrics
- Led internal team study management meetings, developed agendas, captured meeting minutes, tracked, and followed up on action items
- Developed and reviewed study documents
- Functioned as a cross-functional liaison
Clinical Research Coordinator - Phase 3 Experience in Rare Disease
Alnylam Pharmaceuticals
11.2016 - 08.2017
- Maintained of informational databases and program tracking reports
- Reviewed Trial Master File for inspection readiness preparations
- Vendor management- newsletter vendor
- Organized investigator meetings
- Reviewed data
- Reviewed monitoring visit reports
- Managed back up blood samples
- Managed invoices and study budgets
Protocol Care Administrative Specialist for the Melanoma Center and the Center for Immuno-Oncology - Phase 1 experience in Oncology
Dana-Farber Cancer Institute
08.2014 - 11.2016
- Scheduled numerous research protocols, involving interaction with those associated with inhouse studies, grant funded studies, and industry sponsored clinical trials
- Prepared disease specific reports as necessary and managed daily schedule changes which required clinical, operational, and regulatory knowledge of clinical trial protocols
Education
Master of Business Administration - Corporate Innovation and Corporate Renewal
Northeastern University
Boston, MA05.2022
Master of Science - Public Policy
Northeastern University
Boston, MA05.2016
Bachelor of Arts - Environmental Policy and Planning, Minor-Sustainability
University of Southern Maine
Portland, ME06.2014
Skills
- Clinical trial management
- Detail-oriented approach
- Problem-solving skills
- Project Management
- Client communication (CROs, sites, vendors, etc)
- Vendor Management
- Change Management
- Leadership and communication
Languages
English
Native or Bilingual
Timeline
Senior Clinical Project Manager, Clinical Operations- Phase 3 experience in Rare Disease
Novo Nordisk Inc.
03.2024 - 10.2025
Senior Manager, Project Management, R&D Implementation Office
Takeda Pharmaceutical Company Limited
07.2022 - 03.2024
Clinical Project Manager - Phases 1 and 2 experience in Infectious Disease
Spero Therapeutics
04.2020 - 05.2022
Senior Clinical Research Coordinator - Phases 1, 2, and 3 experience in CNS
Sage Therapeutics
08.2017 - 04.2020
Clinical Research Coordinator - Phase 3 Experience in Rare Disease
Alnylam Pharmaceuticals
11.2016 - 08.2017
Protocol Care Administrative Specialist for the Melanoma Center and the Center for Immuno-Oncology - Phase 1 experience in Oncology
Dana-Farber Cancer Institute
08.2014 - 11.2016
Master of Science - Public Policy
Northeastern University
Bachelor of Arts - Environmental Policy and Planning, Minor-Sustainability
University of Southern Maine
Master of Business Administration - Corporate Innovation and Corporate Renewal
Northeastern University
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