Michelle (Shelly) Noel
Monrovia,IN
Summary
Diligent Lead Clinical Data Manager with strong background in managing clinical data systems and ensuring data integrity. Proven track record of streamlining data collection processes and supporting clinical trials. Demonstrated proficiency in data management software and meticulous attention to detail.
Overview
30
30
years of professional experience
Work History
Lead Clinical Data Manager
Indivior Inc.
07.2022 - Current
- Responsible for quality and timely delivery of clinical trial data
- Participate in vendor evaluation, qualification, and selection activities, including, but not limited to, review and assessment of SOP/Work Instructions, contracts, and budgets
- Serve as Data Management representative at trial-specific meetings and as primary contact for external vendors; develop, track, analyze, and provide regular status reports on vendor activities as well as internal data management performance metrics
- Provide oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other data vendors utilizing key performance indicators, metrics, and timelines to assess vendor quality and performance. Escalate issues, as needed
- Participate in protocol design and review, providing key input related to the design and data collection, while ensuring consistency and adherence to data standards
- Lead or assist with development of trial-specific Data Management documentation, including, but not limited t, Data Management Plan, eCRF Completion Guidelines, database (eCRF/edit check) specifications, data validation/data quality plan, external data transfer specifications, and SDTM mapping specifications
- Lead or assist with review of trial-specific eCRF and SDTM deliverables to ensure compliance with CDISC (CDASH/SDTM) and applicable company data standards
- Lead or assist with development of User Acceptance Testing (UAT) plans. Coordinate and/or participate in execution of UAT
- Oversee reconciliation of external data sources. Partner with Pharmacovigilance colleagues to perform reconciliation of serious adverse events and other trial-specific events, as required
- Proactively organize and facilitate holistic data review by the team throughout the conduct of trials to ensure timely and appropriate identification of trends, anomalies, and quality issues
- Ensure proper closeout and archival of Data Management trial documentation, as required by the trial-specific Trial Master File Oversight Plan
- Ensure compliance with all applicable laws, regulations, and regulatory guidelines
- Understand and follow applicable SOPs/Work Instructions/Forms. Review and provide input into the development and implementation of Data Management and related SOP/Work Instructions/Forms
- Serve as Data Management Lead on projects
- Led a team of data management specialists to ensure timely completion of project deliverables.
Principal Clinical Data Manager
Atorus Research LLC
04.2021 - 06.2022
- Served as Data Management Lead on projects
- Served as primary contact for Data Management with all relevant parties including but not limited to Clinical Operations and sponsor stakeholders
- Managed sponsor relationship and triage information and issues as appropriate
- Proactively coordinated and facilitated assignments of tasks and responsibilities to team members to support delivery of timely and high-quality results
- Provided training and guidance to less experienced Data Management team members
- Developed and implemented project timelines
- Planned and executed multiple Data Management projects simultaneously
- Provided input, assistance and/or oversight with preparation of edit check specifications, case report form (CRF) design and specifications
- Assisted and/or managed creation of test data for entry screens and edit checks
- Assisted and/or provided oversight on user acceptance testing (UAT) for assigned projects
- Created and maintained project-specific Data Management Plan (DMP) and other relevant study documentation
- Provided study status tracking and metrics
- Reviewed data listings and reconciliation
- Discrepancy and query management
- Ongoing maintenance of electronic trial master file (eTMF)
- Performed study finalization activities
- Ensured team member performance supports project budget and delivery requirements
- Effectively managed project scope and ensure any changes to scope or out of scope are documented and approved per change order management process
- Coordinated and participated in internal and external study team meetings, as required
- Active involvement in department meetings and initiatives
- Participated in and/or contribute to sponsor and/or regulatory audits and inspections
- Performed other duties as required by department
Data Management Trial Manager
PRA Health Sciences
05.2020 - 04.2021
- Served as Data Management Lead on projects
- Managed all operational aspects of clinical trials in compliance with GCP regulations, PRA policy and client company policy
- Ensured timelines of deliverables for each phase of study from study start-up through production and close-out activities
- Interacted with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Project Management, Safety, Medical Coding, and site personnel
- Ensured Clinical Data Management staff maintains all relevant documentation associated with each assigned protocol
- Identified and worked collaboratively and cross-functionally to implement process improvement measures within Data Management on both departmental and project level.
- Coordinated with Clinical Data Management staff, client, and study team to identify issues/trends for discussion.
- Participated in study/project team meetings as primary facilitator of timelines, providing updates on study status to cross-functional team
Lead Project Data Manager
Covance Clinical Development Services
10.2018 - 05.2020
- Served as Data Management Lead on projects
- Serve as expert in Clinical Data Management to provide oversight and advice to clinical project team regarding CDM activities and deliverables
- Provided Data Management oversight for all allocated vendors/staff
- Monitored timelines and ensured that CDM deadlines were met
- Provided input and guidance to design of clinical databases
- Troubleshooting and resolution of software and clinical database problems
- Reviewed and provided guidance on specifications and UAT/validation requirements for database testing
- Conducted EDC demonstrations and training
- Tested and validated SAS programs for Data Management tools (metrics, reports, patient profiles, etc.)
- Coordinated with medical/safety group on serious adverse event reconciliation
- Liaison with third-party vendors
- Management and oversight of vendor contracts, resourcing and budgets
Senior Clinical Data Manager
Syneos Health
03.2014 - 09.2018
- Served as Data Management Lead on projects crossing therapeutic areas and sponsors
- Served as expert in Clinical Data Management to provide oversight and advice to clinical project team regarding CDM activities and deliverables
- Provided Data Management oversight for all allocated vendors/staff
- Monitored timelines and ensured that CDM deadlines were met
- Provided input and guidance to design of clinical databases
- Managed data reviewers in India on data review, query creation, query closure, and database lock
- Conducted EDC demonstration and training
- Responsible for Data Management budget review
- Responsible for appropriate resource allocations to studies
Senior Data Manager
Randstad Pharma
02.2013 - 01.2014
- Reviewed complex data for three (3) Phase III global studies with very aggressive timelines
- Reviewed patient narratives for errors and inconsistencies
- Created queries when needed for errors and inconsistencies
- Closed queries once site response was received
- Completion of all tasks were performed in InForm database
Senior Data Manager
Quintiles
03.2012 - 06.2012
- Lead three (3) large Infectious Disease and Neuroscience Phase III clinical trials. This involved all data management activities from study development process through final database lock
- Worked closely with management to ensure that trials were kept within budget and all milestones were met
- Provided metrics for each trial to study team and internal management
Senior Clinical Data Manager
PharmaNet/i3
12.2008 - 03.2012
- Lead numerous Endocrine and Neuroscience Phase II, III, and IV clinical trials
- Responsible for interim/final database lock activities
- Lead Instructor for classroom training courses for all new Clinical Data Managers and other functions working on studies. This training not only included systems that were used for clinical trial data but also encompassed training for all processes used
- Coached/mentored new CDMs on day-to-day activities
- Attended/presented at study start-up meetings with investigators, study coordinators and CRAs
Clinical Data Management Coordinator
Eli Lilly And Company
05.1995 - 10.2008
- Lead numerous Endocrine and Neuroscience Phase II, III and IV clinical trials
- Responsible for interim/final database lock activities
- Lead instructor for classroom training courses for all new Clinical Data Managers (CDMs) and other functions working on studies. This training not only included system that were used for clinical trial data but also encompassed training for all processes used
- Coached/mentored new CDMs on day-to-day activities
- Attended/presented at study start-up meetings with investigators, study coordinators and CRAs
- Traveled to numerous locations to train all study sites and users on study specifics and data management processes
- Worked closely with peers in training group to roll out system enhancements, review new SOPs, guidance documentation and job aids
- Participated in process-improvement initiatives
- Provided metrics for each trial to study team and internal management
- Subject Matter Expert on multiple topics (Serious Adverse Event, InForm System, Clintrial System, InForm User Activation, System Security and Grants Payments)
- Trained TCS in Delhi, India on validation process
- Served as Security Administrator for all Clintrial, I-Review and AS400 account requests
Education
Associate of Applied Science - Business
Indiana Business College
Indianapolis, IndianaHigh School Diploma -
Monrovia High School
Monrovia, IndianaSkills
- Data management leadership for studies
- Data quality assurance
- Timely trial completion
- EDC database design
- Information gathering and data oversight
- Database migration expertise
- Issue tracking and management
- Clinical data analysis
- User permissions oversight
- User acceptance testing expertise
Therapeutic Expertise and Phases
Endocrinology
Immunology
Gastroenterology
Neurology
Men's Health
Women's Health
Ophthalmology
Rare Diseases
Addiction
Phases II, III, and IV
Timeline
Lead Clinical Data Manager
Indivior Inc.
07.2022 - Current
Principal Clinical Data Manager
Atorus Research LLC
04.2021 - 06.2022
Data Management Trial Manager
PRA Health Sciences
05.2020 - 04.2021
Lead Project Data Manager
Covance Clinical Development Services
10.2018 - 05.2020
Senior Clinical Data Manager
Syneos Health
03.2014 - 09.2018
Senior Data Manager
Randstad Pharma
02.2013 - 01.2014
Senior Data Manager
Quintiles
03.2012 - 06.2012
Senior Clinical Data Manager
PharmaNet/i3
12.2008 - 03.2012
Clinical Data Management Coordinator
Eli Lilly And Company
05.1995 - 10.2008
Associate of Applied Science - Business
Indiana Business College
High School Diploma -
Monrovia High School
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