Project Manager Management
Resume:
MONIQUE C. DAIGLE
Southbridge, MA 01550
****************@*****.***
https://www.linkedin.com/in/monique-daigle-209808114/
Clinical operations leader with 15+ years of project management experience and 10+ years in medical device trials. Expertise in leading cross-functional teams through full study lifecycles with a focus on compliance, efficiency, and stakeholder collaboration. Experienced in vendor management to ensure efficient study execution and support program success. Effective at negotiating site contracts and budgets, and developing study specific documents such as clinical monitoring/safety plans, ICFs, and CRFs/EDCs.
SKILLS
Medical Device Clinical (class 1-3) Trial Management
Phase I-IV Clinical Trial Management
Process Improvement
Clinical Program Management
Risk Assessment and Management
Cross-Functional Team Leadership
Budget Planning and Oversight
Vendor Selection and Oversight
Global Regulatory Strategy Support
Regulatory Compliance
EXPERIENCE
Olympus Corporation of the Americas
Westborough, MA
Clinical Project Manager II, Apr 2024 – Mar 2025
●Led global clinical trials across all phases; developed feasibility questionnaires and completed visits, managed study design, CRFs, database builds, UAT, and data cleaning.
●Responsible for creating and managing site budgets and contract negotiations, oversaw central IRB submissions, and assisted with FDA submissions and reporting. Liaison between CRAs, vendors, and investigators, monitoring site visit activities.
●Created streamlined TMF documentation & structure, study documents and platforms, inc. EDC, ICFs, safety/monitoring plans, and responsible for cross-functional communication and monthly reporting to executive leadership tracking milestone and study objectives.
Clinical Project Manager I, Apr 2020 – Apr 2024
●Executed multi-site GI/AI clinical studies, created study databases, supported regulatory submissions, and authored study reports and abstracts.
●Led SOP development, investigator site selection, and training. Collaborated on risk management and protocol design.
Associate Project Manager, Apr 2019 – Apr 2020
●Managed clinical budgets, site training, vendor contracts, and study documentation.
●Led site start-up to closeout.
●Assisted with monitoring visits as necessary.
Senior CRA, Apr 2017 – Apr 2019
●Conducted site qualification and initiation visits, interim monitoring visits, close out visits and source data verification.
●Managed site compliance, document review, and reporting.
Analgesic Solutions
Natick, MA
Associate Project Manager, Jun 2016 – Apr 2017
●Led cross-functional studies, assured GCP compliance, and oversaw project delivery across cost/timeline/quality metrics.
Neurotech, Pharmaceuticals
Cumberland, RI
In-House CRA, Jul 2015 – Jun 2016
●Supported U.S. and Mexico-based trials from startup to closeout. Managed TMF, IRB submissions, CRF reviews, and vendor coordination.
New England States Consortium Systems Organization (NESCSO)
Shrewsbury, MA
Project Specialist, Jun 2014 - Jul 2015
●Project lead for interstate Learning Communities in Medicaid and Health and Human Service related topics, assisted with budget planning and forecasting, and responsible for research and development of policy papers/briefs.
Biogen Idec (via inVentiv Health)
Cambridge, MA
Clinical Trial Coordinator, Aug 2013 – Jun 2014
●Coordinated study setup, regulatory tracking, vendor management, and UAT for Oracle RDC.
EDUCATION
MS Healthcare Administration
Worcester State University
BS Business Administration
Nichols College
BA Psychology
Nichols College
PROFESSIONAL DEVELOPMENT & ACHIEVEMENTS
Clinical Research Associate Training
Barnett International, 2019
Certificate Program in Clinical Trial Project Management
Physis Global Academy, 2020
Certificate Program in Medical Writing
Physis Global Academy, 2025
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