Senior Clinical Data & Access Management Leader

DEBRA A MORELLO

OBJECTIVE

To pursue a challenging and responsible position with leadership capacity, where I may utilize my present skills and extensive experience and be considered a valuable asset.

PROFESSIONAL EXPERIENCE

1992 – Present Bayer Healthcare Whippany NJ

Manager Lead User Access

Setup clinical studies, site environments and access requests across multiple systems. Ensure setup of user access across different systems and environments for connected components. Provide technical training for users and peers as needed. Manage changes of study user and site setup during the life cycle of study based on multiple platforms. Solve Service Desk ticket issues for studies on different platforms such as Rave, LSH, DisQus. Support regulatory inspection and audit requests for studies/systems. Complete validation and testing activities across diverse access related systems and processes. Maintain documentation completion in compliance with the applicable SOPs for studies related access.

Sr. Clinical Data Processor/Rave User and Site Administration

Rave Account Management, review requests for access to Rave Website and checks for existing account. Set up new accounts and updates roles or studies for existing account holders. Monitor training sessions, update training documentation, and certify training utilizing the Web Based Training System and grant full access to accounts once completed. Review clean database records and revoke access to studies/sites for user no longer needing access. Rave EDC system validations to ensure that the system meets the requirements indicated in the documentation. Record all discrepancies on log and forward to data manager, once resolved verify all edits have been corrected and document. Support helpdesk using Peregrine System for trouble ticket resolution. Document issues from investigator, coordinator or in house user and escalate tickets back to helpdesk. Training coordination activities, ensuring all training material is current and covers all system and process requirements. Ensure that all affected personnel are notified of updates via email. When Instructor Led Training is needed, manage logistics, venue, determines whether this will be online/offline training, use of laptops, documentation, and manages attendee notification. Download impact information to Business Object Reports.

Clinical Data Processor/Electronic Data Capture

Access Database Administrator - control RDE inventory. Load Sitebase and communications software on laptop computers for configuration/shipping to investigator sites. Maintain inventory log for Remote Data Entry equipment in the Access database. Logging incoming Toshiba laptops and install memory upgrade chips and new modem cards. Coordinate the repairs of RDE equipment and determine if repairs can be made in-house or by the vendor. Send out damaged equipment for repair and record in Access database. Correspond with site coordinators regarding shipment and setup of equipment, installation of new modems, and installation of memory upgrades done at the site. Train team members to perform tasks. Correspond with MRAs, CROs, and CDCs regarding site problems during data transfers. Create nodes on NT machine. Create director tables for all new RDE studies and manage iii table in Sitebase. Update Biometry project tracking as Impact Superuser. Export files from Impact to Access Database

Secretary /Senior Secretary (promotion) S&DS Document Specialist (promotion)

Supported two Deputy Directors and 12 Statisticians. Responsibilities included all filing, typing memos/letters, Statistical Reports, various administrative duties. Assisted with telephone coverage, travel arrangements, drug shipments. Supported 4 Deputy Directors, 2 Programming groups and 2 Statistical Groups. Prepare documents for regulatory submission which include clinical trials data, Adverse Events, complex figures and equations. Create computer graphics, tables, and charts. Prepared statistical reports included extensive use of medical terminology. Managed and entered information in the DIDMS (Data Index Management System). Entered and archived documents in Access Database. Implemented the Electronic Job Filing System.

1987-1991 wiggin & dana New Haven, CT

Administrative Assistant/Paralegal

Assisted attorneys (associate/partners). Responsibilities included typing legal documents, phones, filing, billings, meetings, travel, and library research.

TECHNICAL EXPERIENCE SOFTWARE

Microsoft Word Impact

Microsoft Access Business Objects

Microsoft Excel Outlook

Impact Rave EDC System

Business Objects Microsoft Powerpoint

DisQus

EDUCATION

Southern CT State University, New Haven, CT

1980-1983 Studies included English/Special Education

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