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JOHN O.

PARNELL
1013 S. 48th Street
Philadelphia PA 19143
Home Phone (215) 726 5386

OBJECTIVE
I am seeking a position with a dynamic organization with challenging opportuniti
es in the Pharmaceutical Industry.

EXPERIENCE
InVentive Clinical Solutions
Jun 08 to Present
Contract Clinical Scientist- Pfizer (Formerly Wyeth Pharmaceuticals)
Responsible for providing study-level medical and scientific support in conjunct
ion with the Global Medical Monitor. This includes assisting with protocol desi
gn and strategy, medical issue resolution, cross patient data review, creation o
f medical training and investigator meeting materials, decision point preparatio
n, approval of patient narratives, review and approval of clinical data and audi
t response. The Clinical Scientist is accountable for protocol writing, ICF pre
paration, and patient-level data review and is involved with the ADD process, ID
RP, CRF Design, site feasibility, CSR review, and design of the SAP. Manage the
approval for funding and/or drug supply for Investigator Originated Proposals.

GlaxoSmithKline, King of Prussia, PA


Feb 07 to Jun 08
Sr. Study Manager
Manage the implementation of regional studies within the US Biologicals therapeu
tic area. Represent Regional Clinical Operations on internal process improvemen
t teams. Ensure all relevant studies follow current SOPs & GCP. Lead the matrix
team with key study partners. Maintain relationships and monitor performance o
f CROs & other outsourcing partners. Coordinate with Regional Monitoring, Data M
anagement, and Operations Management to ensure on time delivery of studies. Pro
vide input in end-of-study learning debriefs for Study Team. Track timelines an
d identify contingencies and risk planning to meet overall timelines. Manage st
udy start-up, conduct co-monitoring and close out visit activities. Manage clin
ical trial material and assist in forecasting.

Wyeth, Collegeville, PA
Jan 06 to Feb 07
Clinical Trial Manager
Coordinate the timely development, review and revision of analysis and database
design components. Manage the site selection process, investigator contracting/
site budgets/payments. Manage the selection of central labs and CRO's. Manage
the site initiation process and track patient enrollment; site monitoring and si
te close out activities. Coordinate data management activities, management of s
tudy files for the program. Lead and direct the study team and manage study com
munication between medical science and clinical operations.

Wyeth, Collegeville, PA Jan 05 to Jan 06


Trial Support Manager
Responsible for the coordination and management of operational support for clini
cal trial operations. Provide leadership and guidance to the Clinical Trial Sup
port Specialists to ensure that study start-up, maintenance, and closeout activi
ties of clinical trials are conducted according to GCP, ICH and FDA guidelines a
nd within study team timelines. Communicate with Trial Support Director and Clin
ical Trial Director to prioritize projects and studies to insure adequate resour
ces are available.

Wyeth, Collegeville, PA Jan 04 to Dec 04


Clinical Trial Support Specialist II
Coordinates study site selection and study start-up activities. Main point of c
ontact for site communications. Manage site activities such as tracking and ana
lyzing patient enrollment; Researching and analyzing issues with labs and CROs a
nd ensuring study documents are correctly filed in electronic document managemen
t systems.

Wyeth, Collegeville, PA Sep 02 to Jan 04


Clinical Scientist II
Writing the clinical protocol and informed consent, evaluating safety data, and
supporting the Medical function throughout the trial. Manage overall site acti
vities for the study. Provide support for the development of Case Report Forms.
Participates in the selection of investigators. Assist in the development and
execution of investigator contracts and the planning of Investigator Meetings.
Perform site initiation visits and co-monitoring activities.

AstraZeneca, Wilmington, DE Apr 02 to Sep 02


Sr. Clinical Research Scientist
Manage and supports the authoring of the clinical content of Protocols/Protocols
Amendments and Informed Consent Form. Supports development of Case Report Form
s. Supports the authoring of the CRF Review Manual. Assist in the selection of
CROs and other external services providers. Participates in the selection of i
nvestigators. Assist in the development and execution of investigator contracts
. Prepares study start-up documents including investigator study files, enrollm
ent logs, etc. Assists in planning and preparation of Investigator Meetings and
perform Site Initiation Visits. Contributes to the collection of Financial Dis
closure information, and assist in the development of patient recruitment strate
gy.

Covalent Group, Inc, Wayne PA Apr 00 to Apr 02


Project Manager
Manage assigned protocols. Develop plans in achieving time and events schedule
to assure timely completion of milestones, deliverables and projects. Select st
udy sites and development of investigators budgets. Communicate with CRAs and I
nvestigators/study sites. Respond to events, which impact the time and events s
chedule for the project and completion of milestones. Prepare progress reports.
Make certain serious adverse events are brought to the attention of the sponso
r and/or Medical Monitor in a timely fashion and ensure that regulatory reportin
g requirements are fulfilled. Responsible for various task related to study sit
e management such as: co-monitoring activities, reviewing trip reports, collecti
ng pre study documents, managing shipments of study medication, lab supplies and
case report forms/source documents.

Medex, Clinical Trial Services, Essington, PA Jul 99 to Apr 00


Project Manager
Manage and coordinate all resources relating to study site initiation to databas
e lock. Assure that study timelines and budget are met. Collect investigator d
ocumentation and perform site management activities. Prepare monthly status rep
orts. Review case report forms to identify data errors, missing, incomplete and
implausible data. Perform data analysis and prepare data tabulations. Review c
linical trial reports. Write narratives and follow up on reported serious adver
se experiences.

Premier Research, Philadelphia, PA Apr 99 to Jul 99


Data Project Manager
Manage all tasks and timelines of a study related to Data Management, Biostatist
ics, Quality Assurance and Medical Writing.

Covance - AstraZeneca, Wilmington, DE Feb 99 to Apr 99


Clinical Data Manager
Review CRFs for clinical data discrepancies, generate queries, review query resp
onses, and update clinical database.

Wyeth-Ayerst Research, Radnor, PA Sep 92 to Feb 99


Senior Clinical Data Coordinator
Maintain and update computer generated clinical databases by operating a PC. As
sist with the quality assurance of computer generated reports and analyses. Int
eract with management and clinical operations
Groups to provide input in decisions concerning therapeutic areas priorities. P
repare clinical operating plans and protocols, design of case report forms and t
abulation of nonclinical and clinical data.

Biological Abstracts, Inc, Philadelphia, PA Mar 90 to Sep 92


Information Specialist
Select articles of biological and biomedical relevance suitable for inclusion in
database. Edit and index article citations for print and on-line products. Ev
aluate new serials for possible coverage. Conduct on-line searches on various i
n-house files when needed. Responsible for corrections and retractions processi
ng. Train new members of the group, write book synopses and prepare meeting cit
ations as required.
Wistar Institute, Philadelphia, PA Sep 88 to Sep 89
Research Technician
Maintain the day to day running of the laboratory. Research the etiology of var
ious retroviruses. Perform various analytical procedures such as HPLC, ELISA, N
MR, and Southern and Northern Blot analysis and enzyme assays.

EDUCATION
Temple University Jan 86 to May 88
Bachelor of Arts in Science Major: Biology Minor: Biochemistry
Pittsburgh Project Management Center Jan 00 to Jan 00
Certification in Project Management Theory and Techniques
Barnett International
Certification in Monitoring Clinical Drug Studies Jan 01 to Jan 01

ADDITIONAL SKILLS
Ability to interact and establish an easy rapport with others. Working knowledg
e of Microsoft Word, Excel, Access, Projects and Publisher. Working knowledge o
f FDA regulations and ICH guidelines.

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