Clinical Research Project Management

Madeline Winchester

Phone: 910-***-****

Email: ********.**********@*****.***

Professional Experience

Project Coordinator

IQVIA Biotech September 2022- Present

Develop project plans, key reports, timelines, and communication trackers for project support. Update and maintain internal systems, databases, tracking tools, timelines and project plans with project specific information.

Manage performance dashboards, analyze event triggers and alerts and determine appropriate follow up for PL or others to act upon.

Prepare and distribute status, tracking and project finance reports, and assist the project managers with budget allocation and approval of invoices.

Identify and escalate discrepancies in project tracking data, timesheet coding, expense data billing etc.

Manage and organize project team and sponsor meetings. Prepare project status reports and materials for meetings.

Create and coordinate all information and communications for assigned projects.

Establish and maintain all project documentation including all files, records and reports according to the scope of work and SOPs. Assist with periodic review/audit of files for accuracy and completeness.

Manage study specific training and oversee compliance. Assist in the training and orienting of junior project staff.

Systems used: Medidata, EDC/RAVE, PSR, Veeva Vault, Microsoft (Teams, Excel, PowerPoint, Outlook, Project).

Clinical Research Coordinator

Accellacare April 2022 – September 2022

Coordinated complex clinical research protocols in compliance with regulatory laws and institutional guidelines.

Performed study start-up duties including protocol implementation, production of a recruitment plan, as well as screening participants for eligibility and scheduling of visits.

Collected clinical trial data via source documents/progress notes and into case report forms (CRFs) as required by the study protocol and sponsor.

Completed subject visits including; collection and recording of vitals, phlebotomy, specimen processing and shipping, medical history, subject questionnaires, EKG recordings, and drug administration/accountability.

Performed SAE/AE reconciliation, lab data reconciliation and identified protocol deviations, and other unanticipated problems appropriately. Managed research data to maintain quality and compliance.

Participate in site initiation, interim monitoring, and study close out visits with sponsor and FDA initiated audits. Resolved clinical trial queries for database locks.

Acted as liaison in support of clinical protocols with pharmaceutical sponsors, investigators and CROs. Built strong relationships and provided ongoing communication about trial status and participants.

Provided education/training for others within the department.

Maintained site and study compliance with SOP, and GCPs, ICH guidelines.

Project Management Intern (Full Time)

PPD May 2021 – April 2022

Provided support to project teams in Vaccine Phase II and Phase III studies.

Assisted Clinical Operations leads with data queries, and site monitoring.

Collaborated in the drafting of project management plans, communication plans, and study timelines for study start-up.

Curated high level project timelines for both internal and sponsor view.

Developed and maintained a resource tracking system for the entirety of the vaccine therapeutic unit.

Investigated therapeutic unit unsupported hours and produced solutions to assist team in finance accountability.

Conducted data reconciliation between lab portals and Electronic Data Capture system.

Evaluated sites for study feasibility through site evaluation calls and questionnaires.

Ensured all documents for the study team were submitted to the Trial Master File in a timely manner.

Education

Bachelor of Science, Clinical Research

University of North Carolina Wilmington May 2022

Associate of Science

Brunswick Community College May 2017

Affiliations

Student Association of Clinical Research

Vice President August 2020 – May 2022

Led meetings, organized various philanthropic for the student body, and hosted panels of local clinical research professionals for the members.

Kappa Delta

Philanthropy Chair August 2017 – May 2019

Organized volunteer opportunities for the chapter, kept record of completed volunteer work for over 100 women.

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