Emilie Snow
Lake Lotawana,MO
Summary
Highly experienced Site Management Associate II for Investigator Initiated Studies with a strong background in project management and clinical research. With 19 years of previous experience, I have held various positions such as Sr. Project Management Analyst for Project Leadership/Full Service studies, Clinical Project Support Specialist/Sr. Clinical Project Coordinator for Clinical Project Management/Full Services studies, and Sr. Clinical Trials Assistant/Clinical Trials Assistant in Clinical Operations/Full Service studies. My expertise extends across multiple therapeutic areas including cardiovascular, metabolic, oncology, CNS, immunology, and hematology. In my current role, I provide invaluable project support and assistance to the Local Trial Manager and Global Trial Manager. My responsibilities also include processing and reconciling serious adverse events, managing drug orders, updating project databases, as well as handling document filing/archival and maintenance.
Overview
19
19
years of professional experience
Work History
Site Management Associate II
ICON
03.2023 - Current
- Strategic Solutions Support for 35+ Investigator Initiated and Collaborative Studies
- Assist with any administrative duties requested by Trial Manager and Global Trial Lead
- Run weekly data compliance reports for team
- Perform annual QC checks for vTMF completeness
- Perform QC Archive checks before study transition for closure
- Manage the study closure process from LPLV
- Complete quarterly SAE reconciliations
- Process drug orders and assist in running reports for inventory of drug
- Assist with filing and archiving of Trial Master File documents
- Assists in management of project budgets and Affiliate spend, reconciliation of invoices, final budget and liaises with Accounts payable, as necessary
- Ensures study (s) compliance by maintaining and updating trial management systems, Clinical Trial Management System (CTMS), Trial Master File (eTMF)
In-house CRA 2
ICON, formerly PRA Health Sciences
07.2016 - 03.2023
- Strategic Solutions Support for 35 + Investigator Initiated and Collaborative Studies
- Assist with any administrative duties requested by Trial Manager and Global Trial Lead
- Process incoming SAEs and queries
- Complete quarterly SAE reconciliations
- Process drug orders and assist in running reports for inventory of drug
- Assist with filing and archiving of Trial Master File documents
- Take and record minutes for internal meetings
- Perform annual QC checks for vTMF completeness
Sr. Project Management Analyst
Quintiles
04.2016 - 07.2016
- Prepares presentation materials for meetings (internal/external) and project summary data
- Coordinates project team and/or customer meetings including logistics and materials required
- Update and maintain internal systems, databases, tracking tools, timelines and project plans with project specific information
- Performs Revenue Recognition, Backlog and prepare Sponsor invoices for milestones and pass through expenses monthly
- Identifies and escalates discrepancies in project tracking data, timesheet coding, expense data billing
- Performs a monthly activity forecasting to estimate future invoices for Sponsor
- Prepares and distributes status, tracking and project finance reports, and assists the project manager(s) with budget allocation and approval of invoices
- Takes and records minutes, notes and actions at assigned meetings, distributes and follows up accordingly
- Assists in the training and orienting of more junior project support staff
- Undertakes project management activities as directed by project manager
Clinical Project Support Specialist
Quintiles
10.2013 - 03.2016
- Performs Revenue Recognition, Backlog and prepare Sponsor invoices for milestones and pass through expenses monthly
- Takes and records minutes, notes and actions at assigned meetings, distributes and follows up accordingly
- Update and maintain internal systems, databases, tracking tools, timelines and project plans with project specific information
- Identifies and escalates discrepancies in project tracking data, timesheet coding, expense data billing
- Undertakes project management activities as directed by project manager
- Prepares presentation materials for meetings (internal/external) and project summary data
- Coordinates project team and/or customer meetings including logistics and materials required
- Prepares and distributes status, tracking and project finance reports, and assists the project manager(s) with budget allocation and approval of invoices
- Performs a monthly activity forecasting to estimate future invoices for Sponsor
Sr. Clinical Project Coordinator
Quintiles
01.2011 - 09.2013
- Prepares and distributes status, tracking and project finance reports, and assists the project manager(s) with budget allocation and approval of invoices
- Performs Revenue Recognition, Backlog and prepare Sponsor invoices for milestones and pass through expenses monthly
- Identifies and escalates discrepancies in project tracking data, timesheet coding, expense data billing
- Update and maintain internal systems, databases, tracking tools, timelines and project plans with project specific information
- Coordinate and track all information, communications, documents, materials and supplies for assigned projects
- Takes and records minutes, notes and actions at assigned meetings, distributes and follows up accordingly
- Assists with periodic review/audit of files for accuracy and completeness
- Assists in the establishment and maintenance of all project documentation including all files, records and reports according to the scope of work and SOPS
Sr. Clinical Trial Assistant
Quintiles
10.2006 - 12.2010
- May conduct co-monitoring assignments under supervision of the assigned Clinical Research Associate (CRA)
- Works independently and closely with CRA or Sr
- CRA to accomplish assigned roles and responsibilities associated with project and team goals
- Collaborated with the Clinical Trial Lead (CTL) on the preparation, handling, distribution, filing and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- Assisted with periodic review of study files and completeness
- Performed assigned administrative tasks to support team members and clinical trial execution
- Central support to the clinical project team for designated activities, including coordination and maintenance of project documentation, clinical tracking and information retrieval
- Central contact for the clinical team for designated project communications, correspondence and associated documentation
Clinical Trials Assistant
Quintiles
11.2005 - 09.2006
- Works independently and closely with CRA or Sr
- CRA to accomplish assigned roles and responsibilities associated with project and team goals
- Collaborated with the Clinical Trial Lead (CTL) on the preparation, handling, distribution, filing and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- Assisted with periodic review of study files and completeness
- Performed assigned administrative tasks to support team members and clinical trial execution
- Central support to the clinical project team for designated activities, including coordination and maintenance of project documentation, clinical tracking and information retrieval
- Central contact for the clinical team for designated project communications, correspondence and associated documentation
Education
NA -
Central Missouri State University
Warrensburg, MissouriHigh School, Diploma -
O'Hara High School
Kansas City, Missouri05.1995
Skills
- Informed consent process
- Financials
- Adverse event reporting
- Training and mentoring
- Clinical study reports
- IRB and IEC submissions
- Good clinical practice
- Clinical operations
- Teamwork and collaboration
- Problem-solving
- Attention to detail
- Time management
Personal Information
Title: Site Management Associate II
System Experience
- Clinical Trial Management Systems, ISS Sponsor CTMS, Siebel Clinical (CTMS)
- EDC, Medidata RAVE, Oracle Inform
- TMF, Veeva Vault ETMF
Timeline
Site Management Associate II
ICON
03.2023 - Current
In-house CRA 2
ICON, formerly PRA Health Sciences
07.2016 - 03.2023
Sr. Project Management Analyst
Quintiles
04.2016 - 07.2016
Clinical Project Support Specialist
Quintiles
10.2013 - 03.2016
Sr. Clinical Project Coordinator
Quintiles
01.2011 - 09.2013
Sr. Clinical Trial Assistant
Quintiles
10.2006 - 12.2010
Clinical Trials Assistant
Quintiles
11.2005 - 09.2006
High School, Diploma -
O'Hara High School
NA -
Central Missouri State University
Similar Profiles
Jessica L. PackwoodJessica L. Packwood
Senior Clinical Research Associate I at ICONSenior Clinical Research Associate I at ICON
Dustin NashDustin Nash
Millwright /welder at IconMillwright /welder at Icon
Kathryn HamKathryn Ham
Project Analyst 1 at ICONProject Analyst 1 at ICON