Functional Skills
Clinical Data Management
Data Analysis
Data Governance
Data Management
Data Science
Project Management
Regulatory Compliance
Database Administration
Good Clinical Practice (GCP)
Audit Readiness
Biostatistics
Biomedical Informatics
Clinical Research
Clinical Operations
User Acceptance Testing
Software Skills
Database design
Microsoft Excel
Microsoft Office
Microsoft PowerPoint
Microsoft Word
SAS
SQL
UNIX
Database migration
IBM Watson
InForm Electronic Data Capture
Medidata Rave CTMS
Rave Electronic Data Capture
Sector Experience
Consumer Goods
Healthcare
Life Sciences & Pharma
Experience
EEDM Consulting, LLC
Data Science / Analytics
Clinical Data Management Consultant
7/2016 - Present
I help small and mid-sized biotechs safeguard their trials by bridging the gap between Sponsors and CROs.
Too often, costly delays happen because no one is truly owning the space between Sponsor and CRO. That’s where protocol missteps, EDC rework, and last-minute database lock chaos occur.
With 15+ years in Clinical Data Management, I’ve learned that catching fires before they start is what saves Sponsors months of lost time and mill
Consulting/SME/Contractor work for large and small CROs as well as small start up to mid-size Pharma and Med Device companies. Clients have included: Labcorp, Fortrea, Advanced Clinical,, Ionis, Gilead, MindMed, Relmada Therapeutics and more Roles vary during contracting/consulting include: Lead CDM, CDM Consultant, Sr. CDM, CDM SME, Director of DM, Sr Director of DM, Executive Director of DM, etc.
Complete Study Support from study start up to database lock: eCRF design, EDC database build, programming, UAT, external data integration and validation, SAE reconciliation, data cleaning and query maintenance, Medical Coding, all critical DM documentation throughout life cycle of a study, database lock readiness, EDC decommissioning Establishment of new DM Departments and/or evaluation of and revamp of current DM departments DM Gap Analysis & Inspection Readiness GxP SOP Development/ Review Guidance for strategic program planning, protocol review, EDC selection, Vendor selection, Vendor management Complete EDC system validation for Zelta EDC system
Too often, costly delays happen because no one is truly owning the space between Sponsor and CRO. That’s where protocol missteps, EDC rework, and last-minute database lock chaos occur.
With 15+ years in Clinical Data Management, I’ve learned that catching fires before they start is what saves Sponsors months of lost time and mill
Consulting/SME/Contractor work for large and small CROs as well as small start up to mid-size Pharma and Med Device companies. Clients have included: Labcorp, Fortrea, Advanced Clinical,, Ionis, Gilead, MindMed, Relmada Therapeutics and more Roles vary during contracting/consulting include: Lead CDM, CDM Consultant, Sr. CDM, CDM SME, Director of DM, Sr Director of DM, Executive Director of DM, etc.
Complete Study Support from study start up to database lock: eCRF design, EDC database build, programming, UAT, external data integration and validation, SAE reconciliation, data cleaning and query maintenance, Medical Coding, all critical DM documentation throughout life cycle of a study, database lock readiness, EDC decommissioning Establishment of new DM Departments and/or evaluation of and revamp of current DM departments DM Gap Analysis & Inspection Readiness GxP SOP Development/ Review Guidance for strategic program planning, protocol review, EDC selection, Vendor selection, Vendor management Complete EDC system validation for Zelta EDC system
Elevar Therapeutics
Research
Director of Biometrics
10/2019 - 7/2021
This position provided tactical direction for Biometrics department which included data management, statistics, programming and data standards activities across all projects in all phases of development. Supports high quality conduct of Data Management activities for Elevar projects, from program design via protocol development and study execution through to IND, NDA/MAA Submissions and post approval support, working closely with Medical, Clinical Science, Medical Writing, Clinical Operations and Pharmacovigilance functional areas. Programmed and utilized EDC systems Zelta, iMedNet and Medrio.
Philips
Data Science / Analytics
Clinical Systems Data Analyst
11/2016 - 10/2019
Key Stakeholder for IGT Medical Device Division of clinical data management Operational leadership of data management activities for multiple programs Represent data management at cross-functional team meetings as subject matter expert
CRO and vendor oversight Collaborate with Director of Clinical Operations to plan, build and lead newly established clinical data management department DM Project Manager for several Global medical device (Class III) studies – site concentration in Europe Management of DM vendors providing consistent team direction/guidance and monitoring quality of work through vendor audits and key performance metrics.
Participates in departmental and program specific budgeting Development and maintenance of program level DM deliverable timelines in accordance with program development strategy. Actively drives internal and external timeline negotiations, as needed. Collaborates with Biostatistics, Safety, Clinical Operations, Regulatory and Project Management staffs to meet project deliverables and timeline for clinical device data acquisition, quality checking and reporting Develop, validate, manage and maintain EDC database specifications based on clinical protocol and/or case report forms within Zelta EDC database
Program, manage and maintain database housing Clinical Adjudication Process Facilitate the development and implementation of key data and metrics reports/listings Creation and maintenance of all DM essential documents including annotated CRFs,
CRO and vendor oversight Collaborate with Director of Clinical Operations to plan, build and lead newly established clinical data management department DM Project Manager for several Global medical device (Class III) studies – site concentration in Europe Management of DM vendors providing consistent team direction/guidance and monitoring quality of work through vendor audits and key performance metrics.
Participates in departmental and program specific budgeting Development and maintenance of program level DM deliverable timelines in accordance with program development strategy. Actively drives internal and external timeline negotiations, as needed. Collaborates with Biostatistics, Safety, Clinical Operations, Regulatory and Project Management staffs to meet project deliverables and timeline for clinical device data acquisition, quality checking and reporting Develop, validate, manage and maintain EDC database specifications based on clinical protocol and/or case report forms within Zelta EDC database
Program, manage and maintain database housing Clinical Adjudication Process Facilitate the development and implementation of key data and metrics reports/listings Creation and maintenance of all DM essential documents including annotated CRFs,
Philips
Research
Lead Data Manager
12/2015 - 4/2016
Serve as primary point of contact for customer on data management deliverables Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise Provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
Support DM service delivery with comprehensive DM process and technical expertise in executing projects Serve as the escalation point for unresolved data issues; with guidance, work with client data managers, vendors, internal team members for resolution Create and review and sign-off on all data management documents
Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve Track service performance and provide leadership to identify root causes of issues and implement remedial actions Maintain numerous internal tracking databases and systems, utilizing eTMF system
Support DM service delivery with comprehensive DM process and technical expertise in executing projects Serve as the escalation point for unresolved data issues; with guidance, work with client data managers, vendors, internal team members for resolution Create and review and sign-off on all data management documents
Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve Track service performance and provide leadership to identify root causes of issues and implement remedial actions Maintain numerous internal tracking databases and systems, utilizing eTMF system
Precision Oncology
Data Science / Analytics
Senior Data Manager
9/2015 - 12/2015
Manage clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard
operating procedures, client guidelines and regulatory agency guideline Manage all data-related tasks required to manage clinical data. Responsible for the creation, updating, maintenance and validation of clinical study database including: CRF design and associated completion guideline instructions according to Standard Operating procedures and protocol Data Management Plan development including diagnostic writing and data flow definition through database lock according to Standard
Operating procedures and protocol User Acceptance Testing Reconciliation of AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding Review, analyze, and validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines Assist in standardizing data management procedures such as documentation for departmental standard operating procedures Maintain clinical trial data accuracy through review of case report forms for completeness and consistency Assist in the development and implementation of strategy for data cleaning and in the design and programming of clinical databases
Ability to fulfil a variety of data-related roles while building company strength and experience in data activities Interacts with internal work groups to evaluate needs, resources
operating procedures, client guidelines and regulatory agency guideline Manage all data-related tasks required to manage clinical data. Responsible for the creation, updating, maintenance and validation of clinical study database including: CRF design and associated completion guideline instructions according to Standard Operating procedures and protocol Data Management Plan development including diagnostic writing and data flow definition through database lock according to Standard
Operating procedures and protocol User Acceptance Testing Reconciliation of AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding Review, analyze, and validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines Assist in standardizing data management procedures such as documentation for departmental standard operating procedures Maintain clinical trial data accuracy through review of case report forms for completeness and consistency Assist in the development and implementation of strategy for data cleaning and in the design and programming of clinical databases
Ability to fulfil a variety of data-related roles while building company strength and experience in data activities Interacts with internal work groups to evaluate needs, resources
Atlantic Research Group
Data Science / Analytics
Data Manager
4/2014 - 8/2015
Serves as SME for all things Clinical Data Management and assisting in establishment of newly formed DM Department Authoring of DM SOP and Working Guidances, DM Process Document Templates as growth of DM Department continues to grow and evolve
Authoring and maintenance of eCCGs as well as Data Management Plan(s) (DMP), and ensures compliance with the DMP through the study lifecycle Responsible for developing Case Report Form (CRF), (electronic and/or paper), database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations and UAT within OpenClinia and iMedNet EDC systems Maintains organization of TMF for Data Management Department Leads EDC database (DB) specification process and develops test scripts and execution logs for User Acceptance Testing (UAT) Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs and reconciles electronic data transfers from vendor to Sponsor Ensures clinical data within EDC is complete and ready for database lock/unlock or for freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- including but not limited to: data reconciliation and/or coding Assists in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit Coordinates the archiving of study databases and related doc
Authoring and maintenance of eCCGs as well as Data Management Plan(s) (DMP), and ensures compliance with the DMP through the study lifecycle Responsible for developing Case Report Form (CRF), (electronic and/or paper), database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations and UAT within OpenClinia and iMedNet EDC systems Maintains organization of TMF for Data Management Department Leads EDC database (DB) specification process and develops test scripts and execution logs for User Acceptance Testing (UAT) Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs and reconciles electronic data transfers from vendor to Sponsor Ensures clinical data within EDC is complete and ready for database lock/unlock or for freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- including but not limited to: data reconciliation and/or coding Assists in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit Coordinates the archiving of study databases and related doc
Accelovance, Inc.
Data Science / Analytics
Senior Clinical Data Manager
9/2013 - 4/2014
Represents Data Management on project teams and client meetings, regularly informs Project Management and client of overall project status and potential problems Designs case report forms through RAVE EDC system Writes data management plans according to established procedures Designs and validates the database Provides oversight and direction to Clinical Data Coordinators and Data Entry Technicians Organization and maintenance of eTMF system Updates database as a result of queries other cleaning processes Reviews study database for incomplete data and outstanding data quality issues Performs SAE reconciliation Codes concomitant medicines and adverse events using standard coding dictionaries Directs quality control process CRO and Vendor oversight
I3-Pharmanet
Data Science / Analytics
Senior Clinical Data Manager
7/2011 - 3/2012
Assumes overall responsibility for the successful execution of the data management projects assigned to them. Lead DM with minimal supervision for several midsize to complex projects/partnerships Writes, updates/reviews and approves all required trial data management documentation, documents and presents CRF completion guidelines at investigator meetings Performs any data management activities related to projects, as needed Provides leadership and supervises/train Data Management staff assigned to work on assigned projects, including Clinical Data Coordinators and other Data Mangers, supports training of project staff Monitors the quality and coordinates all data management QC activities for the project Assists in preparation for and complete process of Clinical Adjudication Establishes and coordinates the timely completion of the database lock procedures Serves as Data Management contact with sponsor managing their expectations, noting and responding to out-of-scope work. Liaises with clients on limited basis and produce trial progress reports
Astellas Pharma
Data Science / Analytics
Clinical Data Manager
1/2011 - 7/2011
Aid in the transition of OSI Pharmaceutical acquisition on DM side of clinical oncology studies; gradually taking over role of Lead DM for OSI initiated trials Assessing financial costs, timelines, scope of work for data management outsourcing needs developing, implementing and maintaining Data Validation Plan, including building and testing computer edit checks, with input from Medical, Clinical, Statistics, Programming and RDS
creates annotated CRF documents; collaborates with Clinical to finalize CRF design, reviews CRFs for data issues and inconsistencies; ICD9, CPT and medDRA coding interacts regularly with study team (Clinical and Research Data Science staff) regarding CRF review and completion procedures, CRF audits, data review and case report form completion procedures while participating in data review meetings by identifying potential issues and updating findings collaborating, reviewing and contributing with the database builders toward the development of clinical trial database design/setup; designs user interface using optical character recognition (TELEform or EDC), Reviews and performs User Acceptance Testing (UAT) on data listings programming and testing computer diagnostic edit checks, validation and reports necessary to ensure high quality performs complete and accurate review and processing of clinical trial data; identifying, resolving and clarifying missing, inconsistent or clinically questionable data by issuing queries and verifies subsequent response
creates annotated CRF documents; collaborates with Clinical to finalize CRF design, reviews CRFs for data issues and inconsistencies; ICD9, CPT and medDRA coding interacts regularly with study team (Clinical and Research Data Science staff) regarding CRF review and completion procedures, CRF audits, data review and case report form completion procedures while participating in data review meetings by identifying potential issues and updating findings collaborating, reviewing and contributing with the database builders toward the development of clinical trial database design/setup; designs user interface using optical character recognition (TELEform or EDC), Reviews and performs User Acceptance Testing (UAT) on data listings programming and testing computer diagnostic edit checks, validation and reports necessary to ensure high quality performs complete and accurate review and processing of clinical trial data; identifying, resolving and clarifying missing, inconsistent or clinically questionable data by issuing queries and verifies subsequent response
Astellas Pharma
Data Science / Analytics
Clinical Data Manager
3/2005 - 4/2009
Team Lead, permanent employee. Responsibilities from study start-up to database release include:
Aid in the transition of OSI Pharmaceutical acquisition on DM side of clinical oncology studies; gradually taking over role of Lead DM for OSI initiated trials
Assessing financial costs, timelines, scope of work for data management outsourcing needs
developing, implementing and maintaining Data Validation Plan, including building and testing computer edit checks, with input from Medical, Clinical, Statistics, Programming and RDS
creates annotated CRF documents; collaborates with Clinical to finalize CRF design, reviews CRFs for data issues and inconsistencies; ICD9, CPT and medDRA coding
interacts regularly with study team (Clinical and Research Data Science staff) regarding CRF review and completion procedures, CRF audits, data review and case report form completion procedures while participating in data review meetings by identifying potential issues and updating findings
collaborating, reviewing and contributing with the database builders toward the development of clinical trial database design/setup; designs user interface using optical character recognition (TELEform or EDC), Reviews and performs User Acceptance Testing (UAT) on data listings
programming and testing computer diagnostic edit checks, validation and reports necessary to ensure high quality
performs complete and accurate review and processing of clinical trial data; identifying, resolving an
Aid in the transition of OSI Pharmaceutical acquisition on DM side of clinical oncology studies; gradually taking over role of Lead DM for OSI initiated trials
Assessing financial costs, timelines, scope of work for data management outsourcing needs
developing, implementing and maintaining Data Validation Plan, including building and testing computer edit checks, with input from Medical, Clinical, Statistics, Programming and RDS
creates annotated CRF documents; collaborates with Clinical to finalize CRF design, reviews CRFs for data issues and inconsistencies; ICD9, CPT and medDRA coding
interacts regularly with study team (Clinical and Research Data Science staff) regarding CRF review and completion procedures, CRF audits, data review and case report form completion procedures while participating in data review meetings by identifying potential issues and updating findings
collaborating, reviewing and contributing with the database builders toward the development of clinical trial database design/setup; designs user interface using optical character recognition (TELEform or EDC), Reviews and performs User Acceptance Testing (UAT) on data listings
programming and testing computer diagnostic edit checks, validation and reports necessary to ensure high quality
performs complete and accurate review and processing of clinical trial data; identifying, resolving an