Ladonna Coats
Kyle,Texas
Summary
Registered nurse with 20 years in clinical research. Managed clinical trials in Phase I, II, and III in Drug Safety/Pharmacovigilance and Centralized Monitoring/Risk Management/Risk Evaluation and Mitigation Strategies. Experienced in project management, the development of project plans with risk based quality management, global staff allocations, training and oversight, contracts/proposals, listing reviews with trending, signal section and reporting. Lead teams to meet deliverables on time, in budget and quality. Client/vendor management with pharma and contract research organization perspective.
Overview
20
20
years of professional experience
Work History
Project Manager
PPD
Austin, TX
08.2023 - 04.2026
- Responsible for leading cross-functional teams to deliver successful project outcomes within scope and budget. Implemented risk management strategies to mitigate potential project obstacles. Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals. Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results. Coordinated with cross-functional teams to resolve project issues and mitigate risks. Negotiated contracts with vendors and suppliers, securing quality materials at competitive prices for efficient use of resources.
Data Analytics Manager
PPD
08.2021 - 07.2023
- Responsible for CM activities including strategy and planning such as proposal, Represent centralized monitoring (CM) to internal and external customers. project launch, client discussions, risk assessment, development of plans and budgets, modification of those plans and contracts. Supervise and provide global team training, resourcing, and oversight. Manage CM operational execution of projects to time, quality and cost. Represent centralized monitoring (CM) in internal and external meetings, cross-functional settings, and audits. Lead internal efforts for tool development, process, quality, etc.
Lead Medical Project Coordinator
PPD
04.2018 - 08.2021
- [Lead Medical Project Coordinator (Lead MPC): In addition to Senior MPC (Previous Safety Physician Coordinator)] responsibilities: Coordinate the Medical Management for one or more compound programs for Client Alliances or Partnerships, including training and procedural compliance. Developed and maintain the internal processes, safety and medical management plans, budgets/contracts and timelines, Proactively collaborated with clients; ensured optimal performance and utilization of the MPCs. Train and mentor MPCs and Medical Monitoring staff.
Sr. Medical Project Coordinator (MPC) /Safety Physician Coordinator (SPC)
PPD
10.2012 - 04.2018
- Responsible for the management of safety projects that have Medical Management responsibilities contracted. Coordinated and assisted the Medical Monitor with laboratory review, diagnostic review, clinical listings review, coding review, and Tables, Listings, Figures review. Collaborated with intra-departments for efficient delivery of reviews. Managed budget projections and staff projections as they apply to the Medical Directors/Associate Medical Directors. Responsible for management and client coordination with PPD Medical Monitors on standalone projects to ensure the successful completion of the service deliverables. Ensure contracted services were captured accurately in the contract, timely invoicing, and early implementation of contract modifications. Performed the role of the Project Manager for PPD PVG standalone contracted services. Reviewed, identified, queried, and completed follow up for end points, sentinel and liver events per protocol and processes. Tracked, managed, and maintained responsibility for the PVG budget and Clarity for multiple assigned study phases I-III. Trained and mentored new team members in the role of a Safety Physician Coordinator (SPC)
Senior Safety Specialist
PPD
08.2008 - 10.2012
- Was responsible for the overall coordination of the Serious Adverse Event (SAE) processes for designated projects. Provided department and site training on assigned studies; in addition to, new procedures or procedures that require review. Coordinated and managed of multiple global complex phases I-III trials. Participated in project team/PVG meetings to communicate progress of PVG quality and operational issues. Tracked, managed, and maintained responsibility for the PVG budget and FOCUS for multiple assigned study phases I-III. Served as a mentor to PVG staff for Serious Adverse Event (SAE) processing, SAE database, regulatory reporting, narrative generation and quality control activities. Oversaw expedited reporting and assist staff as needed. Effectively interfaced with project teams, Client Company, and Investigators regarding safety activities from project start-up through database lock. Maintained knowledge and understanding of PPD SOPs; current FDA regulations regarding clinical trials, regulatory documents, and safety issues. Coordinated safety database activities for multiple assigned global projects. Participated in contract activities. Represented PVG at kick off meetings, hand off meetings and Investigator meetings for multiple global assigned projects phases I-III. Reconciled data listings between the clinical/safety database(s). Ensured any expedited safety reports were notified to applicable Regulatory Authorities, Ethics Committees, and Principal Investigators within regulatory timelines. Reviewed compliance of expedited safety reporting on assigned projects and escalated problems or issues to PVG Manager. Prepared for and attended Client company audits, kick-off, investigator, and bid defense meetings. Provided project specific safety training to PPD Clinical on assigned projects. Reviewed, identified, queried, and completed follow up for end points, sentinel and liver events per protocol and processes.
Safety Specialist / Serious Adverse Event (SAE) Coordinator
PPD
02.2006 - 08.2008
- Was responsible for processing Serious Adverse Event (SAE) which included review, safety database entry, tracking, narrative writing, requesting follow-up from site and reporting to client(s) or agencies for assigned projects. Was responsible for adhering to PPD's corporate policies, SOPs/WPDs, and awareness of ICH GCP guidelines and assisted with the development, preparation and revision of department SOP's and WPD's and guidance. Effectively interfaced with Project Teams, Client Companies, and Investigators regarding SAE activities. Reviewed and understood assigned study specific budgets. General understanding of pathophysiology and the disease process, more detailed knowledge of relevant therapy areas as required for processing SAEs. Ensured any expedited safety reports are notified to applicable Regulatory Authorities, Ethics Committees and Principal Investigators within regulatory timelines.
Education
Associate Degree - Nursing
San Antonio, Texas05-1997
Skills
- Registered Nurse
- Microsoft Office; Windows, MS Word, Excel, Power Point; Outlook, Clarity, Synergy, and Spotfire systems
Timeline
Project Manager
PPD
08.2023 - 04.2026
Data Analytics Manager
PPD
08.2021 - 07.2023
Lead Medical Project Coordinator
PPD
04.2018 - 08.2021
Sr. Medical Project Coordinator (MPC) /Safety Physician Coordinator (SPC)
PPD
10.2012 - 04.2018
Senior Safety Specialist
PPD
08.2008 - 10.2012
Safety Specialist / Serious Adverse Event (SAE) Coordinator
PPD
02.2006 - 08.2008