Ian Jimenez Email & Phone Number

Bagsværd, Dk

• Proactively retrieve IND Safety Reports from CONNECT portal and distribute to US/CA Central IRB• Facilitate audit readiness of Trial Master File by closely collaborating with study team• Generate study metrics from Power BI and prepare data extractions for TM review• Ensure documents are uploaded and properly labeled in Veeva Vault throughout the lifecycle of clinical study• CTA Veeva Vault Clinical Trial Management System Super User/Trainer – Promptly resolves CTMS queries pertaining to all CTA tasks within NA Clinical Operations• Mentored new hires as a CTA (Clinical Trial Associate) buddy to facilitate their onboarding and integration into the team• Collaborated with Headquarters to reconcile duplicate site personnel entries in CTMS Global Directory• Collaborated with Headquarters to verify functionality of the new Global Directory Administrator role within CTMS• Support study team as needed with trial related administrative asks

Raleigh, North Carolina, Us

• Assisted with study startup of clinical trials, including feasibility, investigator recruitment, collection of regulatory documents and general site management support• Participated in observational monitoring visit at local site• Assisted in regulatory document reconciliation at local site monitoring visit• Processed, prepared and submitted subject visit payments based on invoices received • Updated and maintained study tracking including a master team contact list• Updated key dates and study team roster in study management databases• Prepared and reviewed of presentations to be used for Site Initiation Visits• Provided regular status updates to the team• Interacted with sites, clinical team, CRAs and other study team personnel to resolve issues with study documents• Tracked and reconciled site payments based on contract details and allocated budget • Reconciled and ensured all final study documents are correctly filed in electronic repository and paper TMF

New York, Ny, Us

• Thoroughly conducted quality control checks and reviewed regulatory documents for eTMF upload• Assisted in creating internal TMF reference model for proper document eTMF metadata identification using TMF 3.0 and PPD TOC

• Reviewed, Scanned, indexed, organized, and structured SharePoint site with internal documents and Correspondence (Safety Reports, Presentations, IRB Approvals, Published Articles, Abstracts, Claims, Clinical Studies)• Collaborated with therapeutic areas on logistics of content management • Lead and Coordinated with Application Services on design of SharePoint repository• FDA Audit support

Princeton, Nj, Us

• Restructured Promotional Compliance documents already residing in First Doc• Renamed and uploaded any additional Promotional Compliance materials as needed• Audited promotional submissions and folders to identify gaps within First Doc• Collaborated with IT Regulatory Support and Compliance Dept. on new system function recommendations• Worked independently on quality check of Trial Master files and CRF documents located in document management system First Doc• Assisted in creating data analysis of CRF findings

• Coordinated with the RA analysts to compile supportive technical documentation for regulatory applications in the EU (Technical Files, Design Dossiers) and US (510(k), BLA, PMA, IDE, IND, Annual Reports)• Reviewing and preparing submission documents to assure submission readiness• Analyzed and organized data to compile US and EU submission metrics for executive management• Maintained, organized and ensured protection of critical regulatory files, including FDA submissions and Health Authority correspondence• Worked independently to obtain data needed to support regional regulatory submissions, as identified by the RA team• Coordinated meetings with RA team to outline gaps and organization needs of regulatory documentation in the document management system, OTIS (Online Total Integration System)

• Analyzed and organized data to produce monthly business metrics reports for executive management• Analyzed and organized data for weekly reports on documents meeting periodic review criteria• Processed document uploads into the Electronic Document Management System (eDMS)• Trained users on proper document validation and uploading procedures used in EDMS• Assisted in creating job aid documentation for uploading procedure into eDMS• Provided certificates for hardware/virtual server installation and audit requests• Managed I/T Quality System Documents inbox• Validated eDMS user application for system access • Created user reports to manage and monitor eDMS access licenses

• Diligently maintained department records in accordance with departmental SOPs• Conducted maintenance, organization and audits of Trial Master Files• Indexed, analyzed and prepared Trial Master files and contract files for vital protection using GREATS (Global Records Electronic Archive Tracking System)• Supported Risk Management in identifying/retrieving SAE and AE case documents• Processed incoming and outgoing records from offsite storage using Iron Mountain Connect• Trained employees on use of Microfilm reading/scanning equipment to review reels of vitally protected documents.• Assisted Data Management with priority projects (including first pass data entry, updating Auto Encoding of Adverse Events in Oracle Pharmaceutical Application, CRF reconciliation)

Paris, France, Fr

• Imported AE documents into GRESDA-Documentum• Archived incoming Ad/Promo items along with Adverse Event documentsRCTS data verification• Conducted auditing of all documents filed (correspondence, AE, annual reports, ad/promo)• Scanned documents for electronic archiving

New Brunswick, Nj, Us

• Analyzed and organized documentation to create files and records • Scanned legal documents and catalogue for retrieval • Assisted with general file room responsibilities as assigned • Electronically filed documents into web based library

• Trained employees in Archiving procedures • Partnered with Records Retention Managers to condense and translate survey questionnaire for Latin America Conference on Records Management • Updated and maintained records management website on local intranet Ortho Biotech Products, L.P., Bridgewater, N.J. Health Care Compliance, Sep, 2004 – Aug, 2005

• Effectively handled calls received on Healthcare Compliance Hotline from all internal and field based employees • Professionally communicated with all levels of management within the organization • Knowledge of SAFE and ARIBA applications • Complied with procedures for check requests such as entering into ARIBA, voiding if check is mishandled or lost, communicating with A/P on check errors • Processed and resolved Tax ID issues • Searched for OIG Debarment