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 resolution. o Ensures consistency and accuracy of information and reporting through periodic checks and identifies issues; resolves issues through data collection and reporting improvement efforts• Knowledge of Celgene Clinical System navigation and user interfaces to perform data entry efficiently• Participation on clinical teams to obtain and share essential information for data entry and analysis; ensure validity of data across multiple stand-alone systems• Have knowledge and understanding of other relevant study/country/site/subject data and the corresponding Clinical System related data capture and/or reporting activities (i.e. CTMS, IVRS, Clinical Trial Portal, EDC, eTMF, Contracts Management System)

• 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 needed.

• 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 Audits.• 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.• Assures timely submissions of research data, laboratory specimens, and query correspondences to all research affiliates and statistical centers. • Obtains and maintains valid Dangerous Goods Shipping Certification. • Centrifuges human specimens per study specific laboratory manual guidelines.• Reports, tracks, and files off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within the required time frame dictated by the IRB of record. • Utilizes the SAE reporting log to track the receipt, submission and acknowledgement of off-site SAEs per protocol.

• 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 • Clean database by generating data queries, performing QC of data, reviewing data listings and complete data integrity review using CTMS, Documentum, and Excel.• Performed quality checks on electronic TMF documents

• 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• Track CRFs as they are brought in-house• Update clinical database based on query resolutions• Clean database by generating data queries, performing QC of data, reviewing data listings, etc.• Participate in project meetings when appropriate• Routinely interface with cross-functional team members• Liaise with CRO providers, when necessary

• 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.• Developed quality assurance database checks• Contribute in usability testing• Perform needed maintenance to the database and the query monitoring system, resulting from returned data listing reviews, coding feedback, and edit checks• Understand the implications and identifications of regulatory and study documents (FDA1572s, monitoring visits, drug shipment, closeouts, etc.)• Participate with data management team in study auditing activities (Visually review data listings to CRF)• Document prep, batch, validate, verify and QC CRFs using Kofax and EDGE an electronic data capture system• Assisted in amending SOPs• QC and update Trial Master/Investigator files using Trialworks, an online system for CRAs and Study Managers• Review and data entry of fields from CRFs, CRF Clarification Forms, DCFs, Protocol Deviation Logs

• 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 adhered to (client) in compliance with protocols and GCP• Contribute into the usability testing of new databases and validation programming• Identify, resolve, or query problematical data observed during data entry raised by electronic checks or manual review using EDC tools• Identify errors or inconsistencies from standard data cleaning checks, reports and listings. Resolve them or generate accurate data queries and initiate their resolution, via the clients preferred approach• Responsible for CRF process flow and query resolution and acting as liaison with study team members/functional groups on all levels, domestic and international, on technical requirements for database development and quality• Developed quality assurance database checks• Perform needed maintenance to the database and the query monitoring system, resulting from returned data listing reviews, coding feedback, and edit checks

• 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• Assisted in amending SOPs• Identify, resolve, or query problematical data observed during data entry raised by electronic checks or manual review • Convert raw data into PDF for testing purposes• Provide management with testing materials for final validation• Verify accuracy of PDF• Identify errors or inconsistencies from standard data cleaning checks, reports and listings. Resolve them or generate accurate data queries and initiate their resolution, via the clients preferred approach• Perform timely update of tracking databases in order to maintain an accurate status of data processing (e.g. data entered, cleaned and (QC’d)• Able to provide status information on allocated data to the Trial Data Manager

• 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