Gail Atherton Email & Phone Number

Farmington, MO, US

United States

• Assist the Project Manager, in planning, initiating, executing, and closing projects in accordance with the agreed Scope of Work
• Ensure Trial Master File (TMF) is complete and accurate
• Monitor and coordinate efforts of cross-functional project teams
• Track project progress, identify and evaluate project risks and take appropriate corrective action
• Ensure all project activities have been fully completed
• Prepare and present project information at internal and external meetings

St Louis, Missouri, United States

• Provides support to surgical equipment product development, line extension, and maintenance of business projects
• Maintenance of the product Design History File (DHF), project files, configuration management logs, etc.
• Manage & maintain the electronic documentation stored in Enterprise PDM (Solidworks)
• Assist and participate with internal & external audit related activities of project documentation
• Assist with compilation of project submittals such as 510(k)
• Cross functional team collaboration with Project Managers, Engineers and Quality Control

St. Louis, MO

• Track project deliverables under the direction of the Project Managers
• Maintain project schedules in MS Project
• Attend and report on all Project Meetings as required
• Prepare meeting materials, including reports, presentations, and agendas
• Take meeting minutes and distribute to all project team members
• Document and follow up on important actions and decisions from meetings

St. Louis MO

• Liaised with Quality Management department during third-party audits
• Scribed during five-day FDA audit and provided support during three-day EMA audit by providing audit documentation
• Maintained confidential information in audit reports
• Mentored team in preparation for scheduled client audits to ensure all required study documents were available in TMF (project master file) to third-party auditors to reduce audit findings
• Led using prepared presentations in internal audit project team meetings and participated in quality management meetings
• Wrote and revised departmental SOPs and followed GCP, GDP, and GDPR and ICH guidelines to meet regulatory requirements

St. Louis MO

• Proactively led quality control to minimize risks to meet project deliverables by following regulatory and company standards as well as study guidelines for data integrity and consistency
• Mentored personnel for compliance in reviewing, acknowledging and understanding SOPs, SWIs, GCP, GDP, GDPR, ICH regulations, procedures and policies
• Trained, mentored, monitored, managed, coached and coordinated team maintaining 10% or less error rate on QC tasks
• Provided support to specialists and Project Managers to ensure study documents and study schedules were met to stakeholder satisfaction and within time lines for various therapeutic areas
• Monitored studies and provided status report metrics generated from EDC systems
• Served as escalation point to resolve conflicts

• Instrumental in decreasing turn-around-times by 10% for study data to meet deliverable deadlines
• Primary site contact regarding study processes and query resolutions to ensure the success of studies by meeting deliverables and creating stakeholder satisfaction
• Performed QC on demographics and image data submitted through EDC systems and reconciled databases
• Reviewed post expert review electronic case report forms (eCRFs) for accuracy
• Blinded, edited, digitized and prepared image data prior to importation into databases
• Performed document management of study files and data

St. Louis MO

• Received and tracked incoming data
• Tracked and shipped study related equipment, study documents and media to sites
• Responsible for storage and maintenance of study files
• Performed administrative duties in support of teams
• Proficient in Microsoft Office Suite, G Suite, email and phone etiquette

Farmington, MO

• Managed an office of 18 sales agents advancing the office to the #2 sales office in the local Board of Realtors
• Negotiated and wrote terms in sales contracts which resulted in solid executable contracts
• Foreclosure specialist for HUD REO properties
• Formalized and documented departmental policies and procedures and oversaw compliance with state regulations
• Monitored, provided industry knowledge, and represented clients throughout the residential loan closing process (FHA, VA, Conventional, and USDA loans)
• Monitored documentation on contracts which ensured a successful audit performed by the Missouri Real Estate Commission

• Serviced and built business relationships by providing excellent service
• Prepared and presented written bid proposals
• Conducted research to identify and propose solutions to problems
• Prepared presentation that persuaded the board to acquire equipment which increased sales by 10%
• Designed and implemented marketing strategies, materials and website to increase presence and sales by 20%

Farmington MO

• Oversaw operations and management of a business that included staffing, scheduling, inventory control, purchasing, accounts payable, sales, budgeting, profit forecasting, advertising, marketing, quality control and.
• Orchestrated a grand opening with near-record breaking regional first week sales volume of $24,000
• Continuously achieved high monthly and platinum level bi-annual awards, as well as surpassing sales from the previous year by 20%

Bachelor Of Science - Bs, Business Administration

Associate Of Science - As, Pre-Medicine/Pre-Medical Studies