Summary
Overview
Work History
Education
Skills
Timeline
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Amy Doherty BSN, RN

Freehold,ASU

Summary

Senior Clinical Monitoring Manager with over 20 years of experience in clinical research. Specializes in developing monitoring strategies and ensuring compliance across all trial phases. Proven leadership in managing teams and improving quality standards. Dedicated to fostering growth and driving operational improvements.

Overview

28
28
years of professional experience

Work History

Sr. Clinical Monitoring Manager

Medtronic
Freehold, NJ
07.2018 - 07.2025
  • Developed and executed monitoring strategies, budgets and resourcing for multiple clinical trials across various business units (primarily Neuromodulation and Cardiovascular).
  • Coordinated with study teams and clinical functions to ensure compliance with protocols, SOPs, GCP, and regulatory requirements.
  • Managed direct reports, fostering professional development and accountability.
  • Conducted regular reviews of processes related to monitoring systems to identify areas for improvement.
  • Led investigations into quality assurance audits, inspections, and CAPA development to enhance quality.
  • Participated as a stakeholder in due diligence processes during acquisitions.

Clinical Monitoring Manager

Medtronic
Freehold, NJ
10.2012 - 07.2018
  • Executed all monitoring activities for assigned business unit and therapy.
  • Provided expertise and support to ensure compliance with study protocols and regulations.
  • Assured successful conduct of clinical studies following monitoring plans and SOPs.
  • Maintained alignment with applicable policies within assigned business unit and therapy.

Sr. Clinical Research Monitor

Medtronic
King Of Prussia, PA
04.2009 - 10.2012
  • Served as the Lead Monitor effectively communicating monitoring activities, site performance metrics, and identified risks to project management, data management, and medical teams.
  • Conduct regular on-site and remote monitoring visits (interim monitoring visits - IMVs) to ensure protocol adherence, source data verification, patient safety, and compliance with all applicable regulations (ICH-GCP, FDA, local regulations, SOPs).
  • Authored and reviewed monitoring plans, corrective action plans, and quarterly trending of action items to identify study trends.

Clinical Affairs Project Manager

Synthes USA
West Chester, PA
05.2006 - 04.2009
  • Oversaw management of multiple IDE studies and Clinical Research Associates for each project.
  • Conducted site audits to ensure comprehensive monitoring accuracy.
  • Managed Adverse Event Reporting to FDA and Data Safety Management Board (DSMB).
  • Key stakeholder in preparation and submission of two PMA submissions to FDA.
  • Designed, organized, and presented content for Investigator and Coordinator Meetings, ensuring effective communication of study protocols and updates.

Clinical Trials Specialist

Synthes USA
West Chester, PA
05.2004 - 05.2006
  • Conducted monitoring visits at Investigational Sites, including site initiation and routine interim assessments.
  • Managed daily operations of multiple active human Clinical trials to ensure compliance.
  • Contributed to preparation and submission of PMA documentation to the FDA.

Manager, Clinical Research (Vascular Surgery)

Hospital of the University of Pennsylvania
Philadelphia, PA
07.2000 - 05.2004
  • Independently managed and coordinated all clinical trials activities (average 10 trials/year) ensuring strict adherence to study protocols, ICH-GCP, FDA regulations, and institutional policies.
  • Managed patient recruitment, screening, consenting, and data collection from initiation to termination of each trial.
  • Acted as liaison among monitors, sponsors, and industry representatives.

Nurse, Surgical- Telemetry Unit

Hospital of the University of Pennsylvania
Philadelphia, PA
09.1997 - 06.2000
  • Oversaw patient care for surgical and trauma cases in a 39-bed unit.
  • Served as charge nurse across all shifts, managing staff and patient needs.

Education

Bachelor of Science - Nursing

Bloomsburg University
Bloomsburg, PA
01.1996

Skills

 Clinical Research Expertise:

  • Clinical Trial Management
  • Good Clinical Practice (GCP)
  • Regulatory Compliance
  • Clinical Monitoring & Quality Assurance
  • Inspection Readiness and Support

Leadership & Management:

  • Strategic Planning & Execution
  • Team Leadership & Development
  • Change Management
  • Resource Allocation & Optimization
  • Budget Management & Financial Oversight
  • Conflict Resolution

Technical/Software Proficiency

  • CTMS, EDC, Veeva Vault, Microsoft Office Suite, Power BI

Timeline

Sr. Clinical Monitoring Manager

Medtronic
07.2018 - 07.2025

Clinical Monitoring Manager

Medtronic
10.2012 - 07.2018

Sr. Clinical Research Monitor

Medtronic
04.2009 - 10.2012

Clinical Affairs Project Manager

Synthes USA
05.2006 - 04.2009

Clinical Trials Specialist

Synthes USA
05.2004 - 05.2006

Manager, Clinical Research (Vascular Surgery)

Hospital of the University of Pennsylvania
07.2000 - 05.2004

Nurse, Surgical- Telemetry Unit

Hospital of the University of Pennsylvania
09.1997 - 06.2000

Bachelor of Science - Nursing

Bloomsburg University

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Amy Doherty BSN, RN