Requests
0
Keep in touch with meI'm using Intch to connect with new people. Use this link to open chat with me via Intch app
Work Background
University of North Carolina WilmingtonAdjunct Professor
Aug. 2024
Launch TherapeuticsExecutive Director - Data Management
Jan. 2023 - Dec. 2024Boston, Massachusetts, United States
Premier ResearchDirector, Clinical Data Science - Women's Health and Diagnostics
Jan. 2022 - Jan. 2023
Premier ResearchHead of Data Management (Legacy Health Decisions)
Oct. 2020 - Jan. 2022
Campbell UniversityAdjunct Professor
Sep. 2020 - Aug. 2024
Premier ResearchAssociate Director, Data Management (Legacy Health Decisions)
Nov. 2018 - Sep. 2020Durham, North Carolina
Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health)Sr. Manager, Data Management
Mar. 2018 - Oct. 2018Raleigh-Durham, North Carolina Area
Syneos Health (Previously INC Research/inVentiv Health)Sr Manager, Data Management
Sep. 2016 - Mar. 2018Raleigh, North Carolina
Syneos Health (Previously INC Research/inVentiv Health)Biometrics and FSP Training Specialist
Feb. 2016 - Sep. 2016Raleigh, North Carolina
Syneos Health (Previously INC Research/inVentiv Health)Sr. Project Manager, Data Management
Apr. 2012 - Sep. 2016
CmedSenior Clinical Data Manager
Feb. 2011 - Apr. 2012
Datatrial, IncStudy Delivery/Project Manager
Feb. 2009 - Sep. 2010Served as project manager for allocated studies (10) and as principal data manager. Responsible for project resource allocation planning and all budgetary and finance projections and reconciliation for assigned projects, providing weekly resourcing updates and monthly financial review to senior management. Responsible for costing out of scope project work and set-up of project milestones in project planning software. Attends bid defense and kick off meetings as well as industry trade shows, providing demonstration of organization's proprietary EDC software. Serves as senior medical coder, coding adverse event, medical history and concomitant medication data using MedDRA and WHODRUG dictionaries. Creates all project study documentation (Data Management Plan, Validation Specification, Schedule of Events, etc.) and served as QC agent for other project study documentation assigned to fellow project managers. Serves on process improvement committee, reviewing standard operating procedures and working practice documentation quarterly (for revision or retirement). Performs database build and set-up for projects maintained in Oracle Clinical, including validation procedure programming and testing, eCRF and CRF design, data extract set up. Responsible for the coordination of database lock/freeze/closeout activities. Perform Serious Adverse Event reconciliation, discrepancy management tasks, manual review and data entry (when necessary). Provide mentoring for junior associates and support for career advancement and project specific training.
PPDClinical Data Manager
Jan. 2008 - Feb. 2009Serve as lead data manager/project manager for complex and non-complex projects and provide support to Manager, CDM position in accordance with GCP and SOP/WPD guidelines. Work independently and efficiently to perform all data management activities for assigned studies. Responsible for monthly budget projections and reconciliations and provides detailed reporting for projects currently or expected to exceed allocated budgeting. Responsible for CRF and eCRF design and review, protocol review and the creation and maintenance of Data Validation Manual. Serve as liaise with the sponsor as required and communicate with management regarding all data management activities within the study. Provide mentoring for junior level staff on all associated tasks within a study.
PPD, IncClinical Data Associate III
Feb. 2007 - Jan. 2008Serves as lead data manager for non-complex clinical trial studies. Performs all aspects of the data cleaning process with minimal supervision, in accordance with GCP and SOP/WPD guidelines. Performs all functions of CDA II position and other data management activities, such as database design and DVM creation in conjunction with Primary Lead Data Manager. Provide training and instruction to junior staff as required.
PPD, IncClinical Data Associate II
May. 2006 - Feb. 2007Performs checks on the clinical data in accordance with the study specific guidelines to ensure its validity. Performs quality control activities and helps ensure all necessary documentation is created and filed correctly. Assists the Lead CDA with other review tasks as assigned.
Intch is a Professional Networking App for the Future of WorkSee more people like Michele on Intch
300k+ people
130+ countries
AI matching
Get Intch if you'd like to
525823 people
17
Assistant manager
16
Customer service specialist
17
Sr Director, Customer Support
149897 people
17
Sr Director, Customer Support
17
IT Tier 1 Support @ University Hospital of the West Indies
16
Actor