Hardworking and motivated professional with several years of experience and record of success in industry. Solid history balancing team performance, customer service targets and business objectives. Dedicated to working closely with employees to maximize productivity and optimize procedures. Decisive leader with good planning and organizational skills.
Overview
11
11
years of professional experience
Work History
Manager, TMF Operations
Syneos Health (inVentiv) - GSK Pharmaceuticals
Morrisville, NC
06.2021 - 07.2024
Ensured compliance with industry regulations and company policies.
Established processes to ensure efficient workflow throughout the organization.
Conducted performance reviews for team members.
Assessed team member's skillsets and assigned tasks accordingly for optimal efficiency.
Monitored budgets and expenditures to ensure cost-effectiveness while maintaining quality standards.
Resolved conflicts between employees by providing guidance on company policies and procedures.
Provided leadership during times of organizational change or crisis situations.
Enforced customer service standards and resolved customer problems to uphold quality service.
Enhanced team morale and retention through recognition programs and career development opportunities.
Established and monitored KPIs to evaluate performance and identify areas for improvement.
Oversaw daily operations, maintaining efficiency and quality standards.
Led a team 8-13 employees, ensuring high productivity and excellent customer service.
Monitored staff performance and addressed issues.
Delegated work to staff, setting priorities and goals.
Provided leadership, insight and mentoring to newly hired employees to supply knowledge of various company programs.
Held regular one-on-one meetings with employees to review performance and priorities and provide feedback.
Manager, Records Management
IQVIA
Overland Park, KS
06.2020 - 06.2021
Participate in the selection and onboarding process for new staff.
Ensure that staff have the proper materials, system access, and training to conduct responsibilities.
Manage the quality of assigned staff's work through regular review and evaluation of work product.
Identify quality risks and issues, and create appropriate corrective action plans to prevent or correct deficiencies in the performance of staff. Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings, as outlined by Records Management. Manage staff in accordance with the organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues; and resolving problems.
Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by Records Management
Manage staff in accordance with organization's policies and applicable regulations
Responsibilities include planning, assigning, and directing work appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems.
Lead Portfolio Manager
IQVIA
Overland Park, KS
06.2019 - 06.2020
Act as the communication conduit to RM management and project leaders, and provide updates on the current status of their sponsors/studies upon need/periodically.
Provide support to QA and Project Leadership during the audits and Inspections.
Guide/mentor the Quality Project Managers and Leads to resolve project and Sponsor specific records management issues.
Responsible for allocation and utilization of Record Management resources and their respective portfolios.
Quality Project Manager
IQVIA
Overland Park, KS
07.2017 - 07.2019
Provide quality oversight of Trial Master File for a specific customer.
Manage the activities associated with ensuring file reviews are being conducted as per sponsor requirements.
Have oversight of the Trial Master File quality support team.
Work directly with customer counterpart to ensure good communication and coordination of TMF health activities are being conducted.
Track and trend quality issues and follow-up actions for TMF documentation.
Trial Master File Specialist
IQVIA
Overland Park, KS
02.2016 - 06.2017
Acts as an SME for the file management process & all RIM Global department initiatives.
Provides support and mentor training to coworkers within RIM.
Serves as TMF contact for documentation to Project team, cross-functional departments to ensure high-quality TMF deliverables are met on time.
Follows processes for set up, maintenance, and support for assigned TMF projects.
Monitors TMF throughout the study duration, identifies and records quality problems, suggest, initiate, recommends or provides solutions as appropriate.
Reports TMF metrics trending and analysis as appropriate with resolution plans to proactively identify & avoid future issues.
Clinical Trials Assistant
IQVIA
Overland Park, KS
07.2015 - 02.2016
Provided support during audits conducted by external agencies like FDA or EMA.
Maintained communication with sponsors and CROs regarding all aspects of studies including budgeting, scheduling, timelines.
Organized, maintained and updated clinical trial files according to applicable regulations.
Prepared detailed reports on study activities for review by management team members.
Clinical Trials Assistant-Contractor
IQVIA/Aerotek
Overland Park, KS
09.2014 - 07.2015
Organized, maintained and updated clinical trial files according to applicable regulations.
Prepared detailed reports on study activities for review by management team members.
Maintained communication with sponsors and CROs regarding all aspects of studies including budgeting, scheduling, timelines.
Identified potential issues or risks that could impact the successful completion of projects.
Registered Respiratory Therapist
University of Kansas Hospital
Kansas City , MO
06.2013 - 08.2014
Provided therapeutic treatments to patients with respiratory illnesses including oxygen therapy, aerosol medication delivery, chest physiotherapy and airway clearance techniques.
Facilitated communication between caregivers and family members concerning the health status of the patient.
Evaluated effectiveness of treatments by monitoring physiological responses using specialized equipment such as spirometers or pulse oximeters.
Managed mechanical ventilation systems including setting up ventilators and adjusting settings according to physician orders.
Education
Associate of Applied Science - Respiratory Therapy
Johnson Country Community College
Overland Park
05-2013
Associate of Arts - Liberal Arts And General Studies
Johnson County Community College
Overland Park, KS
05-2007
Skills
Performance Management
Staff Development
Verbal and written communication
Performance Evaluations
Staff Training and Development
Cross-functional team management
Team Leadership
Key Performance Indicators
Time Management
References
References available upon request.
Timeline
Manager, TMF Operations
Syneos Health (inVentiv) - GSK Pharmaceuticals
06.2021 - 07.2024
Manager, Records Management
IQVIA
06.2020 - 06.2021
Lead Portfolio Manager
IQVIA
06.2019 - 06.2020
Quality Project Manager
IQVIA
07.2017 - 07.2019
Trial Master File Specialist
IQVIA
02.2016 - 06.2017
Clinical Trials Assistant
IQVIA
07.2015 - 02.2016
Clinical Trials Assistant-Contractor
IQVIA/Aerotek
09.2014 - 07.2015
Registered Respiratory Therapist
University of Kansas Hospital
06.2013 - 08.2014
Associate of Applied Science - Respiratory Therapy
Johnson Country Community College
Associate of Arts - Liberal Arts And General Studies
Professional Pharmaceutical Sales Representative at Syneos Health (inVentiv) - GSK PharmaceuticalsProfessional Pharmaceutical Sales Representative at Syneos Health (inVentiv) - GSK Pharmaceuticals
Recruiting Assistant Intern at Syneos Health (inVentiv) - GSK PharmaceuticalsRecruiting Assistant Intern at Syneos Health (inVentiv) - GSK Pharmaceuticals
Professional Sales Representative at Syneos Health (inVentiv) - GSK PharmaceuticalsProfessional Sales Representative at Syneos Health (inVentiv) - GSK Pharmaceuticals