• Performed support tasks related to the set-up, maintenance and close out of the Trial Master File. Experienced with Phases I – IV and study start up through close out.• Study Documentation: Prepared / assembled study documentation and support the Clinical Project Manager in ensuring the compliance of the clinical trial with internal SOPs and regulations.• Trained staff of 13 associates on Regulatory Document electronic filing• TMF Management: Maintained 98% accuracy of processing study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans• Extensive experience with eTMF system – Veeva Vault• Performed quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified.• Increased records production while improving quality, performance, and utilization targets from years 2020-2022• Participated in preparation/reconciliation of TMF documentation related to audits, inspections and shipments.• Collaborated with Clinical Project Managers, Clinical Supply Unit and QA to manage clinical supplies.• Participated in Kick-off Meetings, Study Design Meetings and phone conferences• Maintained accurate and secure filing systems for documentation to include current active/effective documents inactive documents and obsolete documents.• Provided end user technical support for Electronic Document Management System (EDMS)• Performed internal audits as required, ensured studies were inspection ready.

• Contribute to preparation and review of periodic reports (IND, Annual Safety). Verify files needed to write clinical study reports (CSRs), Investigator Brochures and Regulatory requirements are in the electronic data management system (eDMS) archive, and meet all global SOPs, global standards and regulatory requirements for formatting (e.g., heading styles, language and accuracy)• Compile, track, quality control and timely complete document components for complex medical writing projects which include clinical protocols, protocol amendments, CSRs and key regulatory submission documents such as INDs and CTDs• Support Study Managers by maintaining the Clinical Trial Master Files and documents according to the regulatory procedures. Update/maintain study related databases• Coordinate with outside clinical research organizations’ physical files and electronic data base (i.e., Covance using “Trackwise”)• Manage small projects, organization of meetings and other tasks instructed by my supervisor. • Obtain signatures from site investigators, potential investigators and assist with Bayer legal department statement of agreements, signatures and various budgeting documents

• Participated in departmental development activities including SOPs and work development audits• Developed Standard Operating Procedures (SOPs), forms, methods, procedures, reports and proposals• Expedited change controls in Trackwise database• Addressed annotations and routed SOPs for approval in a timely manner• Organized and facilitated weekly meetings for Research and Development Department• Documented the clinic return and inventory of clinically tested devices

• Maintained metric system, rewards and recognition program and operating licenses• Organized facility wide function such as; training programs, recognition celebrations, offsite meetings and retirement dinners. Events were held for 100 – 200 people on site and off site locations• Compiled and processed documentation relating to facility budgeting and SOPs• Maintained schedules for various meeting rooms and audiovisual resources through Outlook calendar management• Ensured attendance tracking, vacation scheduling, payroll, mail delivery, purchasing, invoicing, petty cash and security assignment programs for the site consisting of 100 colleagues

• Reviewed, analyzed and interpreted data generated from adverse events reported domestic and internationally• Performed the tasks of conducting research and analyzing medical and scientific literature• Provided medical and scientific information to healthcare professionals• Performed the tasks of reviewing bioequivalence study protocols, clinical trial protocols and provide support to the clinical trial team• Handled responsibility of developing concise, accurate and well-written case narratives• Performed the tasks of maintaining the safety database and perform coding of diseases and adverse events according to the project specific coding conventions• Conducted presentations of safety processes at client and investigator meetings

Executive Assistant 1998-2002 Customer Service Supervisor 1994-1998• Provided administrative and operational support to the Senior Vice President of Business Operations.• Handled and safeguarded confidential matters with utmost discretion.• Supervised, managed, and trained staff of 20.• Troubleshoot coverage and billing functions.• Reconciled sales office equipment for inventory control.

Handled and safeguarded confidential matters with utmost discretion.Supervised, managed, and trained staff of 20.Troubleshoot coverage and billing functions.Reconciled sales office equipment for inventory control.