Experience

OncoBay Clinical

• United States
• Research Services
• 1 - 100 Employee

• Clinical Data Manager

  • Jun 2023 - Present



PSI CRO AG

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Data Manager

  • Sep 2021 - Jun 2023

  - Communication with project teams, clients and third-party vendors - Tracking database set-up, testing, maintenance, and data entry input into eCRF design, data validation plan development and user acceptance testing of EDC databases - Assisting the department with the review of study documents - Development of the data management plan and other data management guidelines/conventions, e.g. CRF completion guidelines - Coding medical data with coding dictionaries and… Show more - Communication with project teams, clients and third-party vendors - Tracking database set-up, testing, maintenance, and data entry input into eCRF design, data validation plan development and user acceptance testing of EDC databases - Assisting the department with the review of study documents - Development of the data management plan and other data management guidelines/conventions, e.g. CRF completion guidelines - Coding medical data with coding dictionaries and coding listings review - Data validation, including automatic checks and manual data review, external lab reconciliation and SAE reconciliation - Training of site staff and project teams on CRF completion and data management topics - Tracking and reporting of metrics/activities leading to database lock - Maintenance of Clinical Data Management working files Show less - Communication with project teams, clients and third-party vendors - Tracking database set-up, testing, maintenance, and data entry input into eCRF design, data validation plan development and user acceptance testing of EDC databases - Assisting the department with the review of study documents - Development of the data management plan and other data management guidelines/conventions, e.g. CRF completion guidelines - Coding medical data with coding dictionaries and… Show more - Communication with project teams, clients and third-party vendors - Tracking database set-up, testing, maintenance, and data entry input into eCRF design, data validation plan development and user acceptance testing of EDC databases - Assisting the department with the review of study documents - Development of the data management plan and other data management guidelines/conventions, e.g. CRF completion guidelines - Coding medical data with coding dictionaries and coding listings review - Data validation, including automatic checks and manual data review, external lab reconciliation and SAE reconciliation - Training of site staff and project teams on CRF completion and data management topics - Tracking and reporting of metrics/activities leading to database lock - Maintenance of Clinical Data Management working files Show less



Gemini Staffing Consultants, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Clinical Data Manager

  • Mar 2021 - Aug 2021

  - Responsible for the cleaning and data management of clinical trial data and interfacing with clients. – Provide specifications on the case report forms to the database developer. – Create annotated case report forms, creation of edit checks specifications, produced listing reports, tested clinical databases for ease of entry and similarity to the CRFs – User Acceptance Testing of databases, created data management plans (DMP), generated database queries for discrepant data, generate… Show more - Responsible for the cleaning and data management of clinical trial data and interfacing with clients. – Provide specifications on the case report forms to the database developer. – Create annotated case report forms, creation of edit checks specifications, produced listing reports, tested clinical databases for ease of entry and similarity to the CRFs – User Acceptance Testing of databases, created data management plans (DMP), generated database queries for discrepant data, generate queries to clinical monitors or investigational sites. – Responsible for the overall cleanliness of the data, reconcile external data (labs,etc) and integrate/clean with EDC data, resolve database queries, interface with clients as appropriate, ensure that the data collected conforms to the highest data quality and accuracy. Show less - Responsible for the cleaning and data management of clinical trial data and interfacing with clients. – Provide specifications on the case report forms to the database developer. – Create annotated case report forms, creation of edit checks specifications, produced listing reports, tested clinical databases for ease of entry and similarity to the CRFs – User Acceptance Testing of databases, created data management plans (DMP), generated database queries for discrepant data, generate… Show more - Responsible for the cleaning and data management of clinical trial data and interfacing with clients. – Provide specifications on the case report forms to the database developer. – Create annotated case report forms, creation of edit checks specifications, produced listing reports, tested clinical databases for ease of entry and similarity to the CRFs – User Acceptance Testing of databases, created data management plans (DMP), generated database queries for discrepant data, generate queries to clinical monitors or investigational sites. – Responsible for the overall cleanliness of the data, reconcile external data (labs,etc) and integrate/clean with EDC data, resolve database queries, interface with clients as appropriate, ensure that the data collected conforms to the highest data quality and accuracy. Show less



ASRC Federal

• United States
• IT Services and IT Consulting
• 700 & Above Employee

• Clinical Data Manager II

  • Sep 2020 - Mar 2021



Peraton

• United States
• IT Services and IT Consulting
• 700 & Above Employee

• Clinical Data Manager II

  • Jan 2020 - Sep 2020

  • Enter abstracted data into the Defense and Veterans Eye Injury Vision Registry (DVEIVR) based on business rules, procedural requirements and individual judgment; independently conducts data abstraction with high quality, performing abstraction with a minimal level of guidance and direction. • Perform self-audits • Identify and document possible suggestions for improving the data abstraction process. • Assists leaders and program management in coordinating and producing reports for… Show more • Enter abstracted data into the Defense and Veterans Eye Injury Vision Registry (DVEIVR) based on business rules, procedural requirements and individual judgment; independently conducts data abstraction with high quality, performing abstraction with a minimal level of guidance and direction. • Perform self-audits • Identify and document possible suggestions for improving the data abstraction process. • Assists leaders and program management in coordinating and producing reports for special projects. • Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Abstraction Practices, as well as SOPs. • Develop and maintain good communications and working relationships within project staff and management team • Communicate key project issues to management. • Perform other duties as directed by Clinical Staff Supervisor or project management.

• Clinical Data Manager

  • Jun 2019 - Jan 2020

  -Surgical oncology data manager supporting gastric cancer clinical trials -Manage the delivery of high-quality data from project start-up and planning to project execution and project closeout on several projects. -Independently perform project specific quality control and quality assurance tasks on all projects -Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working… Show more -Surgical oncology data manager supporting gastric cancer clinical trials -Manage the delivery of high-quality data from project start-up and planning to project execution and project closeout on several projects. -Independently perform project specific quality control and quality assurance tasks on all projects -Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working Instructions. -Manage patient protocol information and review protocol and incorporate protocol-specific guidelines into the review of clinical trial data on several projects simultaneously. -Contribute to the design of the databases and forms, ensuring they meet requirements for the entry and reporting of clinical data of varying complexity. -Test new processes and systems for the management of data in clinical trials. -Test clinical trial databases and data entry screens assuring compliance with protocol and institutional processes and procedures. -Process, track, and validate data accurately and on time, in accordance with data processing and entry instructions. -Perform data abstraction and data entry on several different protocols into multiple clinical research databases. -Develop and extract patient clinical data reports for publications and presentations. -Possess proficiency with clinical databases and report tools. -Identify project specific reports and assist in the development of these reports. -Prepare, review, and submit clinical data to monitoring agencies. -Maintain client communication regarding data management project status and review key project questions with clients.



Rebound Medical

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Operations Manager

  • Sep 2016 - Jun 2019



OrthoConnecticut

• United States
• Medical Practices
• 1 - 100 Employee

• Intern

  • Apr 2015 - Aug 2015

  Shadow the director of physical therapy during patient evaluations as well as work with the trainer to help strengthen patients back to health. Shadow the director of physical therapy during patient evaluations as well as work with the trainer to help strengthen patients back to health.