Thomas Bernardo Email & Phone Number

Nottingham, Gb, Gb

-Managing all data management deliverables for assigned studies-Ensures the plan for data management is properly executed by: understanding the requirements for study implementation and data collection, collaborating with project team to develop study-specific edit check criteria, defining, running, and reviewing edit checks and resolving discrepant data, maintaining organized, complete, and up-to-date study documentation.-Performing study setup, specifications, and obtaining necessary approvals.-Coordinating and documenting the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from other central laboratories, CRO's, or Sponsors).-Ensures the accuracy and consistency of clinical databases by: reviewing data and identifying errors/inconsistencies, collaborating with appropriate project team(s) to resolve data issues, tracking outstanding issues and following-up until resolution.-Ensuring accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines.

Malvern, Pennsylvania, Us

-Participate in clinical meetings with Sponsor and KPS personnel.-Ensure data management deliverables are met.-Establish rules and procedures for secure and responsible data sharing with company executives.-Manage data management resourcing for all clinical studies.-Prepare documents and ensure tools are arranged to allow for data capture and data cleaning.-Ensure delivery of a clean and secure database.-Instruct, communicate, coach and mentor others on data management procedures.-Ensure compliance with EMEA, FDA, and ICH GCP regulations and policies as well as ensure compliance with appropriate Sponsor SOPs.

Newton, Ma, Us

-Generate and close data queries according to the relevant guidelines (Manual Review Guidelines/Data Validation Specification)-Conduct in-house data review and provide feedback to LCDM or CRO Vendor through close-out ofdiscrepancy-Conduct reconciliation of SAEs, send out queries as required per data discrepancy, and notifyrelevant Safety Group(s) of possible issues for their action supporting LCDM with all aspects of-SAE reconciliation as defined by SOP and/or WI-Assist with data cleaning for Interim Analysis, Database lock, and any ad hocrequests.-Aid in review of eCRF completion guidelines, Data Management Plan (DMP),Data Validation Specifications (DVS, e.g. edit checks), SAE Reconciliation Plan, Data CleaningPlan and other DM related documentation in conjunction with CRO(s)-Assist in creation and review of User Acceptance Test (UAT) Plans and Test Scripts.-Work with Electronic Data Capture (EDC) vendors and Clinical Research Associates (CRAs) totroubleshoot EDC or site issues, through resolution-Create reports and provide updates on study metrics to the project manager(s).-Update and help maintain eTMF with DM study related documentation-Ensure adherence to Data Management Standards (GXP)

Philadelphia, Pennsylvania, Us

- Perform data management responsibilities for clinical trials held at the Sidney Kimmel Cancer Center. - Work in concert with clinical research coordinator and regulatory coordinators to ensure proper execution of patient data collection, entry, and communication between TJU and study sponsors.- Day-to-day activity may include but not limited to: Case Report Form (CRF) designing, CRF annotation, data-entry, data validation, discrepancy management, medical coding, data extraction, and assessment for accuracy/quality at regular intervals during a trial.

Philadelphia, Pa, Us

- Coordination of assigned Children’s Oncology Group clinical trials. - Assistance in keeping relevant protocol and patient information updated in the Oncology Research Clinical Trial Management System. - CHOP Oncology Protocol Support Office Coordinator Meetings and continued education and training within the CHOP Research Institute.- Maintaining up to date knowledge on policies from IRB, FDA, ICH, GCP, or other sources as related to assigned research trials.

Developed and organized training for undergraduate students, SCHOLARS (Students Committed to Helping Others Learn about Autism Research and Support), who served clients directly. The trainings instructed SCHOLARS on the proper Applied Behavioral Analysis (ABA) techniques and procedures when working with individuals on the Autism Spectrum. Oversaw and aided in data collection during social and life skills sessions as part of goal setting and monitoring. Worked with families to ensure skills learned/taught at the Kinney Center connected to their environment at work, home, or school. Orchestrated skill selection based upon goals, family discussions/desires, and base-line data assessment.Served as an instructor and support to SCHOLARS during sessions. This included but was not limited, data collection, teaching assistance, implementation of behavior protocol (based in ABA), and ensuring a least restrictive environment for clients. Following the conclusion of each session, provided feed-back to SCHOLARS in order for future improvement and building of ABA skills such as teaching and behavior procedures.Provided oversight for the Kinney Center's ASPIRE program, designed to aid college students enrolled in the university adjust to life on campus and in the surrounding community. Personally supervised a small group of SCHOLARS and worked closely with clients/fellow students who each had varying desires which included social, academic, personal, and future career goals.

Philadelphia, Pa, Us

Served as both an undergraduate and graduate RA under Elizabeth A. Becker, Ph.D

Philadelphia, Pa, Us