PERSONAL PROFILE
Expertise in clinical drug trial and regulatory documentation auditing meeting ICH Guidelines, GCP and SOP compliance, regulatory, and government required reporting. Additionally provided:
•Quality Document Management •Trial Management System Quality Checks
•Training Programs •User Acceptance Testing
Education:
•Bachelor of Science in Healthcare Management graduated May 2005
•Master of Business Administration w/ Concentration in Healthcare Management graduated
February 2008
•Doctoral of Healthcare of Administration 2009 - Present (graduate 2013)
PROFESSIONAL EXPERIENCE
SANOFI AVENTIS, Bridgewater, NJ
Trial Management Associate 2011 -present
Track study timelines, in all company Clinical Trail Management Systems (CTMS) applications such as IMPACT, CLUBNET, and CTI. Update IMPACT with study timelines, study site information, tracking of monitoring visits. Contact CRA’s of action and issues from Business Object (BO) reports, and track site quality and compliance with Business Object (BO) reports. Assist CTOM with operational planning and activities for the implementation and conduct of studies (clinical trials, observational trials. Coordinate and support Clinical Trial team activities through regular meetings: teleconferences with preparing agenda, meeting minutes. Assist representatives from CSUs/affiliates/CROs with study activities. Assist with management of the flow of task with the CRO’s. Maintain the filing and archival of the TMF. Managing and coordinating of the study eRoom. Assist with checking investigator compliance against CTMS /IMPACT system. Tracking of investigator regulatory documents and submission of documents to regulatory liaisons. Vendor notification of tracking and updating of site supplies. Maintaining and updating study Who’s Who study list. Update and track study site information in Club Net. Collaborate with legal in negotiating and preparing site and consultant contracts. Collaborating with Regulatory and country affiliates on collecting of Insurance of Certification and Policy. Working with outsourced projects and CRO’s on feasibility (selection of sites). Collecting and tracking of regulatory documents. Process Scope of Work (SOW) and Financial budget of the clinical trial study. Prepare timelines through OPTIME and collect METRIC data through Clinical Trial Information system, Business Object, Polaris/IMPACT. Maintain and Monitor eRoom access for internal and external use.
SANOFI AVENTIS, Bridgewater, NJ 2002-2011
Regulatory (Submissions) Regulatory Coordinator 2006-2011
Support activities related to the review committee process, the maintenance of regulatory documentation and the FDA post-marketing submissions process. Responsible for the filing and archival of FDA Form 2253 for all sanofi-aventis advertising and promotional materials, as well as supporting the tasks associated with the FDA post-marketing submissions process. Track and process NDA and IND Medwatch safety reports and CIOMS safety reports (Pharmacovigilance) completing data entry in RCTS, GRESDA. Track and process NDA 15 Day safety reports (Pharmacovigilance) completing data entry in RCTS, Domasys and GRESDA. Track and process IND safety reports with completing data entry in GESDA. Data importation of NDA and IND submissions in database systems used such as
GRESDA, RCTS and DOMASYS. Audit company products against paper trial and various database systems RCTS /GRESDA, DOMASYS data entry. Perform maintenance audits against electronic databases - RCTS, GRESDA, and Domasys reports. Processed and reviewed AD PROMO materials on all company products, checked AD PROMO material against what was submitted ion the 2253 form. Data entry of AD PROMO in RCTS database. Audit and QC all company product material before and after submission, and before sending electronically to the FDA. Retrieve documents from various resources to close out audits and fulfill request.
Clinical Trial Coordinator (permanent employee) 2002-2006
Aventis (Bridgewater, NJ)
Clinical Trial Coordinator (CTC) Medical Affairs/ Clin-Op group (Aventis)
Making sure study sites are in compliance with GCP, GLP with study regulations. Responsible for the oversight, coordination and monitoring of assigned clinical trial studies by therapeutic area. With the help of the CTM and clinical team. Review of a clinical trial documents to ensure it adheres to regulatory and ethical standards. Assist lead Clinical Trial Manager with distribution of Investigator site study start up packages. Shipment of study drugs. Retrieval of all study documents 1572, ICF, protocol signature pages, Investigator and all clinical study staff CV, and licenses and making sure licenses are up to date). Track and review documentation of clinical study activities using IMPACT and CTS. Maintain and update Trial Master Files. Prepare study CSA and CDA’s (contracts) for study sites, vendors and DSMB group. Get legal department approval for all contracts. Making sure all sites have all study related documents approved by IRB, and track all periodic reviews from the IRB. Distribute all correspondence letters, and study material to the study sites. Work closely and assist monitors with investigator site close-out. Track SAE’s and collect signatures for protocol deviations. Updated the status of shipped study drugs through IVRS/PROFILE system. Process Study site, vendors, and DSMB payments and enter in AP system for finance department approval for payments. Served as a support/resource person for questions/procedures concerning regulatory document collection/management to all therapeutic areas. Supported internal personnel in the use of IMPACT and Profile information management systems.
Clinical Study Coordinator (contractor) 2001- 2002
Aventis (Bridgewater, NJ)
Making sure study sites are in compliance with GCP, GLP with study regulations. Responsible for the oversight, coordination and monitoring of assigned clinical trial studies by therapeutic area. With the help of the CTM and clinical team. Review of a clinical trial documents to ensure it adheres to regulatory and ethical standards. Assist lead Clinical Trial Manager with distribution of Investigator site study start up packages. Shipment of study drugs. Retrieval of all study documents 1572, ICF, protocol signature pages, Investigator and all clinical study staff CV, and licenses and making sure licenses are up to date). Track and review documentation of clinical study activities using IMPACT and CTS. Served as a support/resource person for questions/procedures concerning regulatory document collection/management to all therapeutic areas. Supported internal personnel in the use of IMPACT and Profile information management systems. Maintain and update Trial Master Files. Prepare study CSA and CDA’s (contracts) for study sites, vendors and DSMB group. Get legal department...
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