Daniel Eugene Email & Phone Number

Raleigh, North Carolina, US

eTMF Remediation

• Clinical Ops Study Start-up
• Follow established data collection rules and guidelines for data capture to sustain the quality of the data in the Clinical System
• Establish relationship with respective study teams to ensure proper interpretation of data entry into key clinical systems.
• Read source documents such as meeting minutes protocols, vendor reports and enter data in specific data fields.
• Compile, sort and verify the accuracy of data before it is entered.
• For assigned studieso Perform data analysis and run quality control checks within Clinical System to ensure compliance to data capture procedures; interface with functional areas on quality issues through to.

• Tier testing analyst as well running grids to get correct cost information for each client using Microsoft Access and Excel.
• Prepares reports and assists with statistical analysis using Microsoft Word.
• Perform verification/QA and system testing before implementation and within contractual timeframe agreements. Validate all new, manual, or non-standard setups.
• Verify and ensure accuracy of benefit setup information completed by other Analysts.
• Provide consultative support to internal and external clients by researching and assisting with resolution of benefit related issues. Provide benefit and/or group design analysis and system support. Escalate issues as.

• Prepares reports and assists with statistical analysis.
• Organizes and prepares for all study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor.
• Verifies that all patients have provided informed consent prior to entering study specific data.
• Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs.
• Records accurate data by completing paper or electronic CRFs.
• Resolves data queries accurately and within study specific timeframes.

• Clean database by generating data queries, performing QC of data, reviewing data listings using InForm and PL/SQL to run queries.
• Participate in project meetings when appropriate
• Routinely interface with cross-functional team
• Responsible for managing document control for all studies
• Responsible for annotations of all eCRFs and their design templates and provide timely updates
• Update clinical database based on query resolutions

• Protocol review
• Responsible for managing document control for all studies
• Provide input into CRF design and CRF completion instructions
• Assist in defining data entry conventions
• Participate in testing edit checks
• Perform data entry on clinical study data in Oracle Clinical and/or other database systems

• Responsible for managing document control for all studies
• Data discrepancy/resolution: cross checked data, generated and resolved queries, and corrected database for Phase I and Phase III Imaging/Therapeutics studies
• Coordinate and ensure that documentation is edited, reviewed, and filed in a timely manner to meet established deadlines
• Perform all duties in a manner consistent with site and corporate cGMP, SOPs, safety, environmental, and human resources policies and procedures
• Liaisons with clinical teams and regulatory library
• Responsible for reviewing, scanning and indexing regulatory and trial master file documents.

• Generation of standard reports using an Oracle Clinical-based, EDC internet reporting system (PhOSCo) for various clinical trials
• Provided accurate data acquisition and furnish accurate and well-documented study databases to the statistical and clinical teams
• Convert HTML files into PDF format.
• Bookmarked PDF formatted files using Adobe Acrobat.
• Ensure trial documentation is reviewed e.g. protocol, validation, document and Case Report Forms (CRFs) and provide input as appropriate. Ensure relevant working practices or standard operating procedures (SOP) are.
• Contribute into the usability testing of new databases and validation programming

• Prepare, compile and manage regulatory submission documents using a Document Management system (DMPS)
• Data entered cases from CRF to database and reviewed data for discrepancies
• Manage legacy data for an electronic submission to FDA
• Building virtual documents and repository structure
• Managing the virtual document life cycle from draft to lockdown
• Ensure ongoing data entry from CRFs into the clinical trial database within agreed timeframes to a high standard of accuracy

• Reviews and verifies data while comparing information from application to criteria for policy reinstatement and approving reinstatement when criteria are met.
• Checks computations of interest accrued, premiums due, and settlement surrender on loan values.
• Calculates premiums, refunds, commissions, adjustments, and new reserve requirements, using insurance rate standards
• Data entered cases from CRF to database and reviewed data for discrepancies