Clinical Research Manager

• Dec 2021 - Present

Independent Contractor - Clinical Affairs

• Sep 2020 - Present

Clinical Affairs

• Apr 2021 - Oct 2021

Medical Writing Project Manager

• Mar 2020 - Sep 2020

• Responsible for the planning and development Clinical Evaluation Reports to support client’s medical devices. Manage Clinical Evaluation Reports (CERs) and associated documents according to established procedures. • Develop and manage CER project plans, timelines, and project tracking tools in collaboration with other key stakeholders. • Track of the progress and outcomes of the projects. • Work closely with Director, medical writers and client to kick off new projects, and update changes in deliverables •. Laiase with customers to align and communicate expectations. • Plan and deliver Bannick and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner. • Perform periodic reviews of risk documentation, product labeling, and marketing brochures as part of the clinical evaluation process. • Participate in and/or perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature and state of the art to support assigned product lines. • Consistently apply applicable global regulations and guidelines, as well as policies and procedures • Responsible for collecting, maintaining, archiving and retrieving all documents necessary to ensure compliance with SOPs. • Help develop/write reports • Serve in a supervisory capacity; train and provide higher level guidance in the development of project management tools and mentor staff in SOPs, tools and technical guidelines Show less

National Project Manager (joint appointment with University of MN )

• Nov 2004 - Aug 2019

Author ongoing publications and submissions, serve on Executive Committee. Author ongoing publications and submissions, serve on Executive Committee.

Clinical Trial Manager, Device Office

• Jun 2017 - Jun 2018

• Lead clinical teams and provide work direction to functional leads. Support the needs and timelines of the sponsor and the study sites for multiple studies. • Work collaboratively on protocol development, protocol writing, and pre-award logistics. • Determine study objectives, strategy, scope, budget and project timelines. • Develop Clinical Investigational Plans, Case Report Forms, Data Management Plans, Monitoring Plans, Risk Management Plans and study-specific SOPs. • Contribute to Clinical Study Reports and Clinical Evaluation Reports. • Collaborate with physicians and functional leads including biostatistics, clinical laboratories, data management, monitoring, medical writing, regulatory, and budgeting to ensure successful communication and study execution across the lifecycle of studies. • Maintain audit readiness and manage adherence to GCP for all studies. • Utilize complicated internal software tracking systems for all studies, learn new external software as needed. Utilize Microsoft Project Management software. • Provide daily work direction to team members including regulatory submissions, contracts, training, data management, safety, medical writing, clinical laboratories, and recruitment. • Engage teams in continuous process improvement efforts. • Responsible for forecasting and budgeting for clinical studies, responsible for Trial Master File contents. • Manage content and presentations for investigator meetings and sponsor meetings. Show less

Regional NIH StrokeNet Project Manager

• Apr 2014 - Jul 2016

• Manage NIH StrokeNet Regional Coordinating Center (RCC), including research in prevention, acute, and recovery stroke and vascular trials. • Write annual study progress reports. • Facilitate new investigator grants within the network, encourage and identify new grant ideas to match funding opportunities. Assist new investigators with protocol and budget development, and with NIH submissions. • Contribute to publications and new grant submissions. • Serve on national working group for stroke fellowship training grant, develop training standards, identify recipients, ensure coursework requirements. • Responsible for StrokeNet program development and implementation, including written reports and NIH renewals. • Develop Regional center infrastructure for NIH StrokeNet RCC conducting multiple studies (5-10) in stroke research at multiple satellite hospital sites (17+). Research includes drug and device studies. • Ensure HSP, GCP and HIPAA training at regional sites, direct regulatory submissions, write GCP SOP’s. • Manage workloads, direct recruitment efforts and regulatory submissions, and ensure clean and efficient data collection by staff. • Facilitate meetings, training, conference calls, site selection, and site visits. • Collaborate with physicians, Principal Investigators, and other research stakeholders. • Manage contracts, oversee regulatory submissions/maintenance. • Manage primary NIH U01 infrastructure grant along with all other individual study budgets and NIH sub-award training grant. • Hire, train, and manage central coordinators and support staff at the University of MN, staff are trained and work at UMMC as well as other regional sites, RN coordinators are part of a 24/7 on-call pool. Ensure GCP, HIPAA, COI, and ICH guidelines are followed. • Attend Investigator meetings, annual meetings, and relevant congress conferences as necessary. Show less

National Research Director

• Nov 2004 - Mar 2014

• Direct nation wide multi-site, VA funded research study in Alzheimer’s Disease. • Wrote original protocol with MD, managed site-selection process and set-up, ensured lab standards, and finalized data forms. • Participate in data analysis and ongoing written manuscripts (see publications below). • Project manage 14 sites for accountability and adherence to protocol, operations manual, regulatory and logistical workloads. Facilitate and manage 14 sites for regulatory submissions and amendments, HSP, GCP and HIPAA compliance. • Executive Committee member, co-author. • Recommend protocol changes, monitor safety and consenting issues, problem solve recruitment challenges, and monitor site-specific regulatory logistics. • Maintain communication between 14 study site coordinators, investigators, sponsor, pharmacy, and DNA bank. • Manage budgets, budget requests, contracts and amendments. • Liaison with Coordinating Center in West Haven, CT, labs in Boston, MA, pharmacy in Albuquerque, NM, and the DNA bank in Palo Alto, CA, traveling as necessary. • Present at annual study meetings and national/international conferences. • Serve as expert trainer on assessments, contribute to written training materials. • Outsource required training for sites and serve as psychometric expert for study assessments. • Outsource study monitoring, review reports, and follow up on findings. • Monitor nation-wide DNA substudy implementation, consenting, and collection. • Collaborated to write original protocol, managed site-selection process and set-up, and finalized data forms. • Supervise administrative staff as necessary. • Plan and manage content for annual investigator meetings, attend/present at relevant congress conferences. Show less