Clinical Data Manager with 14 years experience. Detail-oriented and focused on accuracy and efficiency in clinical data review.
Protocol Data Manager
*Coached new Data Manager hires on assigned protocols and as a PDM.
*Mentored new DM hires
*Trained Protocol Data Managers on the the drug program and on the PDM role.
*Worked across sites to assist NJ on a Phase 1 protocol.
*Oversaw Global Data Managers and Accenture Data Managers on assigned protocols.
*Responsible for study start up activities on assigned protocols while maintaining Global Standards (eCRF development, creating validation/derivation requests, creating the data review plan).
*Participated in the Global Standards Champions team, the Pediatric Center of Excellence team and the DM Optimization of Early Process Control and ongoing QC team.
*Provided full support/oversight for assigned protocols as well as provided full support to the Accenture Data Manager and Global Data Manager roles.
*Utilized Integrated Review and later J-review to create reports for the clinical team to review the data.
*Facilitated classes on Integrated review and eDM Oracle Clinical.
*Presented Data Management training slides at multiple Site Investigator visit teleconferences.
*Utilized Sharepoint web site to manage all assigned protocol data management reference materials.
*Functioned as a liason to the India Accenture Data Managers and the protocol team. (Accountable for the dissemination of all DM information including training, QCing DM work, Providing communication and issue resolution for assigned protocols).
*Was responsible for query generation, tracking review and resolution.
*Used computer software (Oracle Clinical, TAO on-site, I-Review, J-Review, SMT, Discrepancy Management, Procedure/Derivation request, My Trials and Sharepoint for retrieval, data listings, error detection and production of standard listing display.
*Responsible for Database lock activities including query generation/resolution, study timelines, data review plan review/tracking, reviewing the overall MedDRA and WHO coding, and vendor management for loaded data in eDM oracle Clinical and TAO (Trial Access Management.
Data Management Associate
*Was responsible for the data management activities for assigned protocols.
*Designed the ClinTrial clinical databases for assigned protocols.
*Designed and reviewed standard case report forms.
*Reviewed MedDRA and WHO coding
*Used computer software (ClinTrial, Oracle Clinical, query review)for retrieval, data listings, error detection, and production of standard display.
*Set up validation and derivation specs(review, copying, editing and testing) for assigned protocols.
*Reviewed clinical trial data for erroneous, missing, or incomplete data as well as updated the database as needed from query responses.
*Aided professors' research projects by collecting data through the Internet and library searches.
*Provided administrative support to Business School faculty and staff. Projects included usage of Excel Spreadsheets and document databases
*General duties associated with the profession.
*Duties included reading job specifications to determine proper binding/packaging of printed materials for each project and completing the job as required.
8/2011 Getting the most from Microsoft Excel
9-10/2009 Validations & Derivations Testing training
7/2009 Managing Emotions and Thriving Under Pressure
3/2009 Advanced I-Review
9-10/2008 Crucial Conversations
4/2007 Validations & Derivations PRS Training
11/2006 DM-Site Monitor Cross Training Site Visit
9/2006 PDM Training
4/2006 Microsoft Project for Data Managers
4/2006 Communicating with Professionalism and Diplomacy
5/2005 Conflict Management for Women
4/2005 Project Management Framework for Clinical
3/2005 eDM Process Procedures
2/2005 Communication training
6/2004 Integrated Review 7
8/2003 How to Become a Better Communicator
6/2000 Medical Terminology
5/2000 Case Report Form Design Seminar
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