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Experienced TMF Manager with a demonstrated history of working in the CRO industry. Skilled in Customer Service, Microsoft Office, Strategic Planning, Time Management, and Customer Satisfaction. Strong professional with a Bachelor’s Degree focused in Business Administration, Management and Operations from Colorado Technical University.
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Sales AssociateJohnston & MurphyJohnstown, Co, Us -
Manager, Tmf OperationsSyneos Health Jan 2022 - Aug 2024North Carolina, United StatesManages TMF Operations staff including TMF Document Assistants and TMF Document Specialists. Oversees study assignments for TMF Operations staff. Monitors staff performance and regularly meets with employees to discuss performance. Conducts performance appraisals at designated time points throughout the year and directly supports staff professional development. Participates in the interviewing and selection process and provides ongoing support during the onboarding phase. Ensures staff adhere to the quality expectation and participates in process improvement efforts for the department.- Participates in and directs activities related to department staff operations such as interviewingand selection, professional development, training, performance management, and employeecounseling and separations.- Conducts courses of action on interviewing and selection, terminations, professionaldevelopment, performance appraisals, and employee counseling.- Works with and advises staff on administrative policies and procedures, technical problems,priorities and methods.- Assigns resources and manages transitions of ongoing studies/processes/workflows.- Manages periodic and ongoing compliance to quality and performance standards of directreports.- Ensures successful delivery of the TMF Operations Key Performance Indicators for directreports.- Ensures staff utilization meets department goals, reviews and approves timecards/expenses byestablished deadline and reviews and ensures staff training compliance.- Prepares and participates in audits/inspections to ensure ongoing readiness of the TMF.- Designs and/or delivers TMF training in various formats via teleconference, video conference,and/or in person.- Actively involved and/or leads department and business unit improvement initiatives.- Coordinates with a staffing vendor to manage a temporary and/or flexible workforce, as applicable. -
Lead Tmf Document SpecialistSyneos Health Sep 2020 - Jan 2022North Carolina, United StatesSuccessfully leading a remote team of 28 contractors across multiple regions, ensuring that deliverables are met, and maintaining quality in the TMF. - Maintain compliance with departmental quality, performance and utilization targets- Complete administrative tasks (e.g., status reports) as requested- Maintain compliance with company requirements (e.g., time tracking, training)- Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments- Ensures the security and compliance of all documents related to active and archived projects - Ability to support complex/study specific systems/processes- Supports logistics for the flexible workforce, as applicable- Ability to work independently with minimal supervision- Attend and support file audits and liaise with Quality Assurance (QA) to resolve audit findings as appropriate; lead facility tours if office-based where audits are conducted-Provide oversight, training and support to more junior members of document management upon management request- Assist with the development of work processes and systems to support document management, including contributing to SOPs and internal department guidance- As assigned under supervisory remit, participates in and direct activities related to department staff operations such as interviewing and selection, professional development, training, performance management, and employee counseling.- Oversees and prioritizes daily work flow for assigned team members.- Assists with monitoring productivity and quality of assigned team members- As assigned under supervisory remit, ensures staff utilization meets department goal, reviews and approves timecards/expenses by established deadline and reviews and ensures staff training compliance- Controls access to the Document Control Room/Trial Master File Room according to applicable SOPs/WIs. -
Sr. Tmf Document SpecialistSyneos Health (Previously Inc Research/Inventiv Health) Nov 2018 - Sep 2020Raleigh-Durham, North Carolina AreaPerforms support tasks related to the set-up, maintenance, and closeout of the Trial Master File. Serve as Subject Matter Expert to coach junior team members.•Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study-specific TMF Plans.•Support the set-up, maintenance, and closure of TMF repositories.•Support documentation collection activities. •Maintain compliance with departmental quality, performance and utilization targets •Complete administrative tasks (e.g., status reports) as requested•Maintain compliance with company requirements (e.g., time tracking, training)•Participates in preparation/reconciliation of TMF documentation related to audits, inspections, and shipments•Perform quality training as required•Ensures the security and compliance of all documents related to active and archived projects•Ability to support complex/study specific systems/processes•Supports logistics for the flexible workforce, as applicable•Ability to work independently with minimal supervision•Attend and support file audits and liaise with Quality Assurance (QA) to resolve audit findings as appropriate; lead facility tours if office-based where audits are conducted•Provide oversight, training, and support to more junior members of document management upon management request•Assist with the development of work processes and systems to support document management, including contributing to SOPs and internal department guidance -
Regulatory Records Specialist IiSyneos Health (Previously Inc Research/Inventiv Health) Apr 2018 - Nov 2018Raleigh, North Carolina, United StatesPerforms support tasks related to the set-up, maintenance, and closeout of the Trial Master File.•Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study-specific TMF Plans.•Support the set-up, maintenance, and closure of TMF repositories.•Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified •Maintain compliance with departmental quality, performance and utilization targets •Complete administrative tasks (e.g., status reports) as requested•Maintain compliance with company requirements (e.g., time tracking, training)•Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments•Participates in study specific training as required•For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room•Ensures the security and compliance of all documents related to active and archived projects•Ability to work independently with limited supervision•Ability to support complex/study specific systems/processes•Guides and supports junior team members•Performs other work-related duties as assigned. -
Regulatory Records Specialist ISyneos Health (Previously Inc Research/Inventiv Health) Jun 2017 - Apr 2018Raleigh, North Carolina, United StatesPerforms support tasks related to the set-up, maintenance, and closeout of the Trial Master File.•Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study-specific TMF Plans.•Support the set-up, maintenance, and closure of TMF repositories.•Support documentation collection activities, including:•Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified •Maintain compliance with departmental quality, performance and utilization targets •Complete administrative tasks (e.g., status reports) as requested•Maintain compliance with company requirements (e.g., time tracking, training)•Participates in preparation/reconciliation of TMF documentation related to audits, inspections, and shipments.•Participates in study-specific training as required. •For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return. Ensures that all applicable paperwork is completed upon the release and return of each project document and/or project file from the Document Control Room•Ensures the security and compliance of all documents related to active and archived projects -
Team MemberTarget Jul 2013 - Aug 2017Raleigh, North CarolinaInteracting with guests and providing an approachable demeanor to better assist with any questions or concerns. • Cash-Handling • Delivered excellent customer service• Retrieve carts from appropriate receptacles• Ensured that various areas of the store are cleaned and stocked• Other duties included price accuracy and sales floor -
Night Shift SupervisorBp May 2012 - Jun 2013Palmyra, VaCash-Handling, ensured that the store was clean and well stocked, generated and submitted my own reports, receiving and stocking new inventory.
Dylan Meeks Skills
Dylan Meeks Education Details
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Business Administration, Management And Operations -
Fluvanna County High SchoolHigh School Diploma
Frequently Asked Questions about Dylan Meeks
What company does Dylan Meeks work for?
Dylan Meeks works for Johnston & Murphy
What is Dylan Meeks's role at the current company?
Dylan Meeks's current role is Sales Associate.
What is Dylan Meeks's email address?
Dylan Meeks's email address is dy****@****lth.com
What schools did Dylan Meeks attend?
Dylan Meeks attended Colorado Technical University, Fluvanna County High School.
What skills is Dylan Meeks known for?
Dylan Meeks has skills like Customer Service, Microsoft Word, Time Management, Training, Team Building, Inventory Control, Microsoft Office, Customer Satisfaction, Strategic Planning, Sop.
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Dylan Meeks
Electrical And Computer Engineering Student @ The University Of Texas At AustinAustin, Tx -
Dylan Meeks
Los Angeles, Ca4gmail.com, altegrahealth.com, adecco.com, adecco.it1 (877) 4XXXXXXX
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Dylan Meeks
Sales Representative At Crown Lift Trucks | Fightin' Texas Aggie Class Of '24Dallas-Fort Worth Metroplex -
2ufl.edu, reelsurgical.com
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