Manager Management
Resume:
June Wright
**** ******* **** ***** **********, N. J. 08536
609-***-**** (Home) 973-***-**** (Cell) ( email: **********@*****.***
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 2002
. Master of Business Administration w/ Concentration in Healthcare
Management graduated
2008
. Doctoral of Healthcare Business Management (expected graduation date
December 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, and
resolution of site issues. Review IP and all study documents for study
close-out. Tracking of investigator (study site) 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 of site selection. 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. Monitor and maintain TMF. Conduct Clinical Study
Unit (CSU) meetings going over business object reports while helping field
CRA's resolve site issues and actions from reports. Collect, track and pay
site investigators, and vendors.
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 approval for all contracts. Track monitor site visits. 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.
Project Assistant (contractor)
January 2000 - December 2001
Pfizer (New London, CT)
Responsible for the review, coordination and monitoring of assigned
clinical trial studies by therapeutic area. Review of a clinical trial to
ensure it adheres to regulatory and ethical standards. Assist lead Clinical
Trial Manager with distribution of Investigator site study start up
packages. 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). Logged all adverse events in CTS data
base. Track ADE's reporting. Updated the status of shipped study drugs
through IVRS/PROFILE system. Track patient /subject study visit on clinical
trials according to protocol.
Medical Program Coordinator (contractor) January 1999
- December 2000
Merck (Rahway, NJ)
Interacting closely with Lead MPC, Medical Monitor, to insure protocol is
followed, and documentation of AE's/SAE's reported by site. Reconciliation
of reporting of AE's and outstanding queries. Making sure study sites are
in compliance with GCP, GLP with study regulations. Responsible for the
review, coordination and monitoring of assigned clinical trial studies by
therapeutic area. Review of a clinical trial to ensure it adheres to
regulatory and ethical standards. Assist lead Clinical Trial Manager with
distribution of Investigator site study start up packages. 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). Logged all adverse events in CTS data base. Track ADE's reporting.
Updated the status of shipped study drugs through IVRS/PROFILE system.
Track patient /subject study visit on clinical trials according to
protocol.
Clinical Study Coordinator 1997 - December
1998
HealthCare Discoveries (San Antonio, TX)
Patient assessment for each study visit. Ensure all protocol activities are
performed to meet protocol requirements, validate potential study subject's
data against inclusion criteria to enroll qualified volunteers. Ensure that
all lab samples are collected properly and tests are performed. Ensure that
laboratory samples are collected and sent out in a timely manner, and
collected properly, and tests are performed at the visit. Reporting of all
SAE's to the sponsor and IRB in compliance with FDA regulations and sponsor
requirements, reporting SAE's within 24hr, and notifies the IRB promptly.
Patient Assessment, record of patient vitals dispenses study medication,
record study compliance of study drug. Track adverse events and the
recording of ADE's and record on source document and transfer to case
report form.
Clinical Project Coordinator
Hackensack University Hospital (Hackensack NJ) 1996 - March
1997
Coordinate and manage assigned studies, ensure all research staff,
including PI and the volunteer to meet protocol requirements, performs all
protocol activities. Conduct all clinical studies according to protocol and
in compliance with the sponsor and FDA regulations and guidelines. Validate
potential volunteer data against pre-established inclusion criteria to
enroll qualified volunteers only. Obtain medical records from other outside
institutions for updating and documentation of events during clinical
trial. Updating and keeping source document accurate at each site visit.
Closed -out unresolved issues on queries and case report forms. Filing of
weekly site status reports to the sponsor/IRB, of each active study. Ensure
that laboratory samples are collected and sent out in a timely manner, and
collected properly, and tests are performed at the visit. Monitoring and
evaluating and making sure in compliance of GCP, GLP. Patient Assessment,
record of patient vitals dispenses study medication, record study
compliance of study drug. Track adverse events and the recording of ADE's.
Record all patient assessments on case report forms. Conduct all clinical
studies according to protocol and making sure in compliance with the
sponsor and FDA A regulations and guidelines. Monitored patients on studies
w documentation of adverse event through patient assessment. Recorded
visits on case report forms.
Study Coordinator
Cancer Therapy & Research Center (San Antonio, TX) 1994- 1996
Conduct all clinical studies according to protocol and in compliance with
the sponsor and FDA regulations and guidelines. Ensure that all research
staff, including PI and the volunteer to meet protocol requirements,
performs all protocol activities. Ensure that laboratory samples are
collected and sent out in a timely manner, and collected properly, and
tests are performed at the visit. Patient Assessment, record of patient
vitals dispenses study medication, record study compliance of study drug.
Track adverse events and the recording of ADE's. Record all patient
assessments on case report forms. Interview study patient each week with
study progress according to protocol design.
PROFESSIONAL DEVELOPMENT & TRAINING
7 Habits of Highly Effective People, Conflict Resolution & Confrontation
Management, Management by Strengths, Managing at sanofi-aventis, Effective
Communicating, Business Writing - Get to the Point!, Recognizing &
Preventing Workplace Harassment, Fundamentals of Patient Recruitment,
Detection of Fraud in Clinical Research, Resilience Alliance, Women
Inspiring Women in Excellence (WISE)
TECHNICAL SKILLS
Word, Outlook, Visio, Excel, Powerpoint, eRoom, IntraLinks, Profile, Ariba,
Catalyst,
IMPACT, GRESDA, DOMASYS, Application for ATC codes using the WHO (WHO
Collaborating Centre for Drug Statistics database), RCTS, CIOMS database,
CTI, Club Net, Business Objects.
AFFILIATIONS
Toastmaster Member 2010 - Present
Healthcare Businesswomen's Association 2006 - Present
Association of Clinical Research Professionals (ACRP) - 1999 - Present
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