Maggie Warren Email & Phone Number

Tarboro, Nc, Us

North Carolina, United States

● Provide oversight for the the Records Management (RM) Quality Project Managers, serving as a point of escalation.● Oversee key accounts and portfolios by assuming RM Service study oversight responsibilities.● Participate in financial forecasting, acting as a subject matter expert, ensuring that financial analyses are completed for all studiesscoped for RM.● Lead monthly forums for financial forecasting and estimate at completion (EAC) processes.● Ensure change in scope… Show more ● Provide oversight for the the Records Management (RM) Quality Project Managers, serving as a point of escalation.● Oversee key accounts and portfolios by assuming RM Service study oversight responsibilities.● Participate in financial forecasting, acting as a subject matter expert, ensuring that financial analyses are completed for all studiesscoped for RM.● Lead monthly forums for financial forecasting and estimate at completion (EAC) processes.● Ensure change in scope management is accurate and complete for RM activities on assigned studies.● Develop strategies to support the team with execution of study timelines, corporate and department quality metrics, resourcemanagement, performance oversight, and team collaboration activities.● Communicate challenges and concerns to RM Line Managers, RM Department Managers, and Project Management.● Support the study teams to drive amendment deliverables as outlined in study plans and per region.● Provide oversight, feedback, and analysis of TMF Inspection Readiness Key Performance Indicators (KPIs) and Metrics and discusswith the Project Team and Sponsors on a regular and ongoing basis.● Assist in the bidding process for RM by reviewing budget proposals.● Liaise with RM Quality Manager, working to prepare the study teams for upcoming audits, attending audits as applicable.● Identify areas of process improvements and coordinate with RM Global Management to resolve issues. Show less

● Oversaw efforts of site file maintenance and study close out with team members for designated global projects.● Participated in financial forecasting for various studies and discussed change in scope and budgets with the Service Delivery Manager.● Served as a core team member in interactions with the Sponsor and sites.● Assisted with study-specific training and mentoring of staff.● Performed analysis of TMF KPIs and quality metrics and provided to the Project Team on a regular… Show more ● Oversaw efforts of site file maintenance and study close out with team members for designated global projects.● Participated in financial forecasting for various studies and discussed change in scope and budgets with the Service Delivery Manager.● Served as a core team member in interactions with the Sponsor and sites.● Assisted with study-specific training and mentoring of staff.● Performed analysis of TMF KPIs and quality metrics and provided to the Project Team on a regular basis.● Oversaw site level timelines and documented study and site-level challenges, communicating them to the Service Delivery Manager.● Completed study and site-specific ICF reviews and ensured that necessary IRB/EC documentation and tracking system updates were finalized.● Assisted with compiling and distributing protocol amendments and associated regulatory documents to sites.● Submitted ongoing regulatory documents to clients and central IRBs and managed ongoing IRB continuing review renewals. Show less

Morrisville, North Carolina

● Supported Site File Associates by leading weekly teleconferences to discuss study tasks and assist with daily team inquiries.● Provided site amendment and regulatory document updates during weekly client teleconferences and internal team meetings.● Distributed protocol amendments and reportable expedited safety reports to sites.● Participated in financial forecasting for various studies and discussed changes in scope and budget with the service delivery manager.● Reviewed… Show more ● Supported Site File Associates by leading weekly teleconferences to discuss study tasks and assist with daily team inquiries.● Provided site amendment and regulatory document updates during weekly client teleconferences and internal team meetings.● Distributed protocol amendments and reportable expedited safety reports to sites.● Participated in financial forecasting for various studies and discussed changes in scope and budget with the service delivery manager.● Reviewed documents received from study sites, IRBs and CRAs, and directly communicated with sites and CRAs to obtain document corrections.● Submitted ongoing regulatory documents to clients and central IRBs and managed ongoing IRB continuing review renewals.● Tracked action items and protocol amendments within their specific systems.● Reviewed TMF KPIs and metric reports on a regular basis.● Reviewed master central IRB ICFs and site-specific ICFs. Show less

Raleigh, North Carolina

● Maintains and coordinates the logistical aspects of clinical projects and provides overall support to functional leads for completion of project deliverables.● Attends Syneos Health Quick Start camps, process review and Kick-Off Meetings, and other project meetings as required.● Transcribes accurate meeting minutes and action items to meet the specifications of the project team and Sponsor.● Prepares and maintains Investigator regulatory binders and site reference tools and ships… Show more ● Maintains and coordinates the logistical aspects of clinical projects and provides overall support to functional leads for completion of project deliverables.● Attends Syneos Health Quick Start camps, process review and Kick-Off Meetings, and other project meetings as required.● Transcribes accurate meeting minutes and action items to meet the specifications of the project team and Sponsor.● Prepares and maintains Investigator regulatory binders and site reference tools and ships materials to study sites.● Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and TMF Plan, as well as prepares and submits documents for review.● Tracks study and site information, as well as reviews and approves site payments in CTMS system.● Manages study team, Sponsor and Vendor access to various project systems.● Assists sites with study advertising efforts. Show less

Morrisville, North Carolina

● Completed study start up activities to assist the sites in timely completion of study documents. ● Corresponded with potential investigators regarding study opportunities.● Reviewed all regulatory documents for GCP compliance.● Completed maintenance activities to support in adhering to study timelines.● Ensured all project documentation was appropriately filed in the TMF per Novella SOPs, or Sponsor SOPs if required.● Performed regularly scheduled TMF site file reviews for… Show more ● Completed study start up activities to assist the sites in timely completion of study documents. ● Corresponded with potential investigators regarding study opportunities.● Reviewed all regulatory documents for GCP compliance.● Completed maintenance activities to support in adhering to study timelines.● Ensured all project documentation was appropriately filed in the TMF per Novella SOPs, or Sponsor SOPs if required.● Performed regularly scheduled TMF site file reviews for assigned studies.● Updated and maintained the PI Database and CTMS systems. Show less

Morrisville, North Carolina

● Updated and maintained the PI Database contact entries.● Corresponded with potential investigators regarding study opportunities.● Supported the PI Database Project Lead on database improvement and data cleaning projects.● Supported SSU Associate with Feasibility Packet development, programming and UAT for the eFQ.● Assisted with creation of templates for regulatory documents specific to local and central IRB/EC submissions.● Updated CTMS system as documents were… Show more ● Updated and maintained the PI Database contact entries.● Corresponded with potential investigators regarding study opportunities.● Supported the PI Database Project Lead on database improvement and data cleaning projects.● Supported SSU Associate with Feasibility Packet development, programming and UAT for the eFQ.● Assisted with creation of templates for regulatory documents specific to local and central IRB/EC submissions.● Updated CTMS system as documents were received.● Assisted with filing of documents into the TMF (paper or eTMF).● Assisted with tracking/filing of reportable expedited safety reports and cross reports.● Performed administrator duties in relation to Novella’s investigator site portal, Novella Conduit.● Completed Novella Conduit system set-up required for regulatory document distribution.● Trained study-site staff on set-up and tracking in Novella Conduit. Show less

Wilmington, North Carolina

Assist numerous professors and students in resolving computer operation issues in a timely manner. Provide walk-in and phone technical support. Assist students and faculty in the technology checkout process.

Master Of Science - Ms, Clinical Research And Product Development

Bachelor'S Degree, Biology, Minor In Chemistry

Activities and Societies: Alpha Xi Delta Fraternity Pre-Veterinary Medical Association