Wendi Wheeler
Quakertown,PA
Summary
Detail-oriented team contributor with exceptional organizational skills and a proven track record of managing multiple projects simultaneously while maintaining a high level of accuracy. Adept at prioritizing tasks and consistently meeting deadlines, ensuring efficient achievement of objectives. Versatile expertise in project management, problem-solving, and collaboration fosters a dynamic work environment that drives success. Recognized for a fresh perspective, strong commitment to quality, and a proactive approach in delivering innovative solutions that enhance overall performance.
Overview
38
38
years of professional experience
Work History
Trial Master File Lead II
Syneos Health
09.2022 - Current
- Attends Trusted Process meetings such as Kick-Off Meetings, QuickStart Camps, Jump Start Camps, Quality Finish Camps, etc. as TMF Subject matter Expert (SME) and successfully communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF.
- Assessed and recommended optimal TMF oversight strategies while ensuring proper study creation and configuration within the eTMF platform.
- Monitors and reports on TMF Health, including identifying risks, issues, and mitigation plans for the project.
- Engaged in comprehensive training initiatives for team members to enhance proficiency in the ETMF platform.
- Coordinated with project and functional leads to manage and submit TMF documentation, ensuring compliance with project requirements.
- Attends internal project team and sponsor teleconferences and face-to-face meetings as TMF SME as applicable to the project.
- Prepares and participates in project-specific audits/inspections to ensure ongoing readiness of the TMF. May participate in qualification audits.
- Provides regular feedback to the Project Team on TMF health/status, including actionable metrics.
- Provides timelines to the Project Team and TMF Operations Team for the TMF transfer, including timelines for final Completeness Checks, document submissions, TMF Export and QC and transfer to the client
- Achieved clarity on project scope, timeline, and budget for TMF, facilitating effective project management. Documented and communicated out-of-scope work to project lead, ensuring timely updates to change notifications.
- Facilitated presentation of monthly TMF status, risks, issues, and corresponding actions for assigned projects during project meetings.
Senior Project Assistant
Icon Clinical Research
03.2022 - 09.2022
- Perform client teleconferences in absence of Project Manager
- Mentor/Assist PA Team new hires and PA Team.
- Assist Manager with special projects.
- Maintain Team tracker with all studies and reporting to Sponsors.
- Provide Training to Team as necessary.
- Create workstreams and Process Improvements.
Project Assistant
Icon Clinical Research
02.2017 - 03.2022
- Assist with the development of project specific Procedure Manual and Staffing Plan.
- Communication based on studies with client, sites and CRAs
- Perform client teleconferences in absence of Project Manager
- Contributed to successful project outcomes by providing comprehensive administrative support to the team.
- Assisted project managers in achieving timely completion of projects through diligent monitoring and tracking of deadlines.
Business Manager
Pinnacle Facilities Group
Quakertown, PA
06.2014 - 02.2017
- Oversee activities of workers; hire and evaluate new employees
- Build and maintain relationships with customers, suppliers and contractors
- Develop office procedures and implement them
- Project management including timelines and budget, Manage staff, preparing work schedules and assigning specific duties.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Used critical thinking to break down problems, evaluate solutions, and make decisions.
Technical Partner
Lehigh Valley Hospital
02.2011 - 06.2014
- Provide direct patient care, including treatments and diagnostic studies and IV care.
- Phlebotomy and accurately entering data into database, correctly labeling, preparing and sending specimens to the lab.
- Utilize effective and appropriate communication to physicians, patients and family members.
- Support unit and hospital goals and objectives.
- Communicate with patients to ascertain feelings or need for assistance or social and emotional support, keeping patients calm and comfortable.
- Document or report observations of patient behavior, complaints, or physical symptoms.
- Record vital signs, blood pressure, pulse, and respiration rate, Perform EKG's, monitor readings and make sure machine is attached properly and in working order, monitor oxygen level.
Annuity Claim Representative
Prudential Insurance Company
Horsham, PA
07.1988 - 12.1998
- Managed claims processing and adjudication, ensuring compliance with company policies and regulatory standards.
- Analyzed claim submissions for accuracy, identifying discrepancies and initiating corrective actions.
- Collaborated with internal teams to resolve complex claim issues, enhancing customer satisfaction and service delivery.
- Developed training materials for new hires, fostering a culture of continuous improvement and knowledge sharing.
Education
Business Administration
Delaware Valley College
Doylestown, PABusiness Administration
Temple University
Ambler, PASkills
- Supportive interpersonal skills
- Teamwork and collaboration
- Service excellence
- Effective problem resolution
- Organization and time management
Timeline
Trial Master File Lead II
Syneos Health
09.2022 - Current
Senior Project Assistant
Icon Clinical Research
03.2022 - 09.2022
Project Assistant
Icon Clinical Research
02.2017 - 03.2022
Business Manager
Pinnacle Facilities Group
06.2014 - 02.2017
Technical Partner
Lehigh Valley Hospital
02.2011 - 06.2014
Annuity Claim Representative
Prudential Insurance Company
07.1988 - 12.1998
Business Administration
Delaware Valley College
Business Administration
Temple University