EMPLOYMENT HISTORY:

Confidential, Princeton, NJ

Drug Safety Assistant

Responsibilities:

• Under the supervision of the Drug Safety PV&DSS System Administrative Director, acted as the Safety Representative (SR), supporting the Argus Safety Enterprise Configuration Process working as a “liaison” between the PV&DSS Senior Managers (Business Owners (BO)), and the Information Technology (IT) ARGUS team.
• Ensured the appropriate authorization and technical support is obtained in order to initiate the enterprise. A ticket request has to be submitted to IT Central and must be approved by the line manager.
• Collaborated with the Business Owner to develop/revise a draft project - specific of the Argus Configuration Form (ACF), identifying the requirements for a new enterprise, or a modification to an existing enterprise in ARGUS
• Submitted draft ACF to the IT Argus team for configuring. Address any issues that might be found on the draft ACF, and re-submit.
• Submitted the final ACF for review and approval. If complete, it must be signed and dated accordingly.
• Prepared for and execute the User Acceptance Testing (UAT) script. For any discrepancies, consult with the ARGUS Administrators for modifications to the ACF if required.
• Reviewed and confirm acceptance of the ARGUS enterprise, by completing the User Acceptance Memo (UAM), and forwarding a copy to the ARGUs Administrators.
• Requested deletion of the test case by completing the Safety Case Deletion Form and forward it to ARGUS Administrators.
• Requested the Release to Production document and collect the appropriate signatures. Once signed, provide copies to all parties (Argus Administrators, Business Owner, Drug Safety). Notify that the ARGUS configuration is ready for use.
• Monitored access controls in accordance with current procedures. Ensure the ARGUS Safety Enterprise User Acceptance Forms (UAF) are completed and being managed in accordance with the latest procedures regarding study specific user access for electronic systems.
• Ensured the User access is revoked immediately if the user leaves the company, or the user no longer requires access.
• Filed the project-specific ACF and supporting documentation, all approved versions of the ACF and the supporting documentation in the study files.
• Supported the STAR Processors team:
• Reviewed incoming email requests from the STAR Study Setup mailbox in Microsoft Outlook
• Validated email request for processing, determining if it is for a new study setup, or an update to a study.
• If a new study setup, collaborated with the Drug Safety Project Manager (DSPM) requesting/obtaining all the initial required information and necessary documentation to complete the STAR System Study Setup Checklist. Also refer to the GPS Tracker to retrieve information as necessary.
• With the STAR System Study Setup Checklist was completed, added the information in the STAR database, have the DSPM sign off the checklist for validation, and completion. Activated the study in STAR and GPS Tracker.
• If an update to a study, processed request in the STAR database, or DSS Staff Case Allocation and Assignment Tool Excel Spreadsheet accordingly.
• Escalated any issues and provide solutions
• Maintained a daily tracker of processed requests (on hold, pending, completed, etc). Forward tracker to the STAR Processing Team providing daily status of the STAR Study Setup mailbox.
• Provided feedback to submitters as necessary.
• Served as liaison (business matter expert) to DPSMs, Sponsors, etc.
• Troubleshooted data entry issues and suggests solutions
• Collaborated with IT department to resolve data quality issues
• Assisted the Drug Safety group in the handling/maintenance of company paper Trial Master Files and file rooms/cabinets which could include ensuring accuracy and consistency of filing and security procedures, and coordinating with other departments and project team members to ensure all project-related paper storage needs, and electronic storage needs on company secured file servers, per the relevant company quality documents, are created and maintained.
• Supported the team during Health Authority Inspections, Audits, or business projects by performing activities such as retrieving original TMF files, ARGUS configuration files, Drug Safety Services files. S canning, printing, and/or photocopying documents to meet timelines or indexing documents required to support Inspection Readiness
• Ran the daily Overdue and Near Due Cases Report
• Ran the weekly (every Thursday) Initial Only Metrics (Finance) Report
• Ran the monthly Late SAEs Cases Report
• Ran the monthly Late SUSARs Cases Report
• Built and maintained good PV&DSS relationships across functional units
• Handled all incoming/outgoing mail/packages, package items, ensured proper labeling, and arranged pickup from UPS, and/or FedEx.
• Any other duties as assigned by management

Drug Safety Assistant

Confidential

Responsibilities:

• Assisted in or completed per the Safety Management Plan (SMP) the processing of all adverse event reports from any source
• Assisted in producing queries of safety data for clients as appropriate
• Assisted in the generation and maintenance of the PV&DSS metrics
• Assisted Data Management or clients on reconciliation of safety databases
• Provided input for monthly status reports
• Maintained a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance
• Possessed knowledge of other procedural documents, e.g., SOPs, and how they impact safety
• Built and maintained good PV&DSS relationships across functional units
• Demonstrated role-specific Core Competencies on a consistent basis
• Assisted in the preparation of client meetings and liaise with clients where appropriate
• Assisted with the set-up of, and the provision of data to, Safety Committees/DSMBs
• Any other duties as assigned by management

Confidential, Collegeville, PA

Clinical Support Specialist

Responsibilities:

• Assisted the Document Control Group (DCG) in the maintenance of company paper Trial Master Files and file rooms, ensuring accuracy, consistency of filing security procedures, and coordinating with other departments/project team members to ensure all project-related paper storage, and electronic storage needs on company secured file servers, per the relevant company quality documents, are created and maintained
• Managed the quality control of documents in the eDx TMF, and collaborated in the migration of documents from eDx (current storage) in to the new eTMF CARS.
• Created place holders for new artefacts (Regulatory documents), as well as previous artefacts.
• Completed study closure tasks, reconciliation of regulatory documents verified accuracy and worked closely with the sites regarding the filing activities to produce deliverables from clinical teams.

Confidential, Princeton, NJ eClinical Operations Associate Liaison

Responsibilities:

• Scheduled and conducted logistics and training meetings with investigative sites, vendors, and Contract Research Organizations (CRO) in order to retrieve BMS files located offsite
• Utilized the company’s Records Management System (RMS) to process box records for long term archiving and retrieval while being in compliance with the relevant work practices and records management practices including lifting record boxes weighing up to 30 lbs. and maintaining documents per Corporate records retention policies
• Integral in multiple electronic trial master file transfers including, but not limited to the following processes: gather and organize large volumes of documents perform quality assessment package the documents electronically for transfer instructed the recipients on the unique file structure of the documents
• Executed Imaging and Quality Control Management processes to manage BMS Sponsor study files in compliance with company guidance and regulatory requirements
• Maintained the quality and integrity of Electronic Study Files (ESF) documents as part of a validated system to support management of clinical trial and regulatory submissions
• Served as a business matter expert to customers and hubs
• Performed daily counts of rejected documents at Prep and/or Scan processes to update the Daily Rejections Tracker
• Performed Quality Control on documents that were rejected at Prep and/or Scan to determine validity
• Ran the Daily Workflow Report
• Created and implemented the following trainings;

Confidential

Data Operations - Study Files Management (SFM) Associate

Responsibilities:

• Supported the daily management of Good Clinical Practice Essential Documents by performing the Document Receipt and Prep Process and by ensuring US-IND Submissions, Priority and Non-Critical documents are processed within 24-48 hours
• Independently focused on ESF priority queues to ensure Study Files Management Team goals are met
• Communicated unusual ESF Indexed document concerns to the team Facilitators and/or Manager for rejection consideration or for further discussion with Indexers, Protocol or Site Manager
• Processed documents for Rejections based on standardized Rejection standards and return the documents to document owner for resolution
• Supported the team during Health Authority Inspections, Audits, or business projects by performing activities such as retrieving original study files or photocopying documents to meet timelines or index documents required to support Inspection Readiness
• Collaborated with SFM Associate Director and Manager providing ongoing status updates and communicating project concerns and suggestions for resolutions
• Actively participated on team committees in support of continuous improvement
• Archived and retrieved Study Files ensuring the Company’s intellectual assets were managed in accordance with Work Practices and in compliance with legal and regulatory requirements
• Supported the ESF Docbase Change Process:
• Reviewed incoming requests
• Validated Requests for review Provide status updates to Senior
• Managed activities on ongoing basis
• Escalated issues and provided solutions
• Maintained current ESF Docbase changes in Documentum
• Provided feedback to submitters
• Indexed CMC regulatory dossiers for scanning
• Performed document scanning and monitored external consultant scanning activities
• Performed quality checks, identifying problems with data received prior to entry
• Troubleshooted data entry issues and suggests solutions
• Quality checked global data entry and followed up with CMC users to ensure accurate and complete information was captured
• Created queries to retrieve information or reports from database
• Collaborated with other departments (e.g. Global Dossier and Document Management, Informatics) to coordinate regular dossier retrieval for scanning and resolve data quality issues
• Created and built Virtual Documents (VD) in PRISMDevInt for the CSI Project