Clinical Project Manager - Biotech Resume Search
Clinical Project Manager - Biotech Resume Search
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Clinical Project Manager Resume


Desired Industry: Biotech SpiderID: 6954
Desired Job Location: Cambridge, Massachusetts Date Posted: 5/16/2006
Type of Position: Full-Time Permanent Availability Date: June 10, 2006
Desired Wage: 83K
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, 25-50%
Highest Degree Attained: Bachelors Willing to Relocate: Undecided


Objective:
A highly motivated individual working in the healthcare field for the past six years with a strong interest in public health and clinical trials research.


Experience:
· EXPERIENCE
Clinical Scientist II, December 2005-present Wyeth Research, Translational Medicine
Major duties include conducting World-Wide Phase I-II clinical trials
o Study Management: communicating and managing all site activities, working with CRAs, sites and study teams both internal and external
o Training and attending monitoring visits for two study protocols
o Working with the medical monitor to develop and implement new studies
o Protocol development for Inflammatory disease indication; with a focus on biomarkers i.e. pharmacogenomics, pharmacokinetics and pharmacodynamics
o Updating the Study Reference Manual and Internal Data Review Plan
o Working with various central laboratory vendors to finalize sample collection
o Leading and mentoring Clinical Research Associates, Clinical Trial Support Specialists and other Clinical Scientists
o Assisting in Data Review meetings on an on-going basis
o Preparing and delivering a study-related presentations at internal meetings, study related documents investigator meetings, and study sites

Clinical Project Manager, April 2004- November 2005 Biogen Idec, Medical Affairs Dept
Major duties include assisting the daily operations of a Phase IV post-marketing clinical drug trial for alefacept (AMEVIVE ®).
o Working with PIs on ISTs (Investigator Sponsored Trials) for off-label use of alefacept.
o Management of a Community Based Trial: performing all start-up and close-out activities with the CRO
o Conducting site and PI selection
o Assist in the Regulatory document process
o Conducting Webex teleconferences as training for sites and PIs.
o Assist in protocol development, creating budgets, drug ordering, working with investigators to develop protocols for ISTs
o Site management in liaison with CRO as well as site monitoring
o Leader of Sub-group committee for Best Practices Group





Clinical Research Associate II - February 2002-April 2004
World Care Clinical, Inc., Imaging CRO for Clinical Trials. Cambridge, MA
Major duties include assisting in the daily operations of designated Phase II-III clinical drug trial(s). Major responsibility included working with CRO’s, sites and physicians on four trials in Oncology and Neurology/CNS disease(s).
Specific duties include:
o Participating in case review with Radiologist, Generating/creating, case report forms (CRFs).
o Maintaining, updating, and testing of patient databases and Radiology software.
o Site monitoring-both in house and on-site monitoring for clinical trials.
o Initiation of sites; mass mailings of starter packets, confirming regular contact. Demonstrated competencies in managing clinical trials data, following proper GCP guidelines, SSP’s and SOP’s for all clinical trials.
o Working with pharmaceutical clients in the New Drug Application (NDA) process.

Administrative & Clinical Research Coordinator- September 2000- February 2002
Tufts New England Medical Center-Department of Dermatology & Surgery, Boston, MA
o Duties include, patient contact, setting up and coordinating appointments and meetings
o Enrolled patients in Phase III Melanoma Clinical Trial
o Assisting in research grant proposal writing
o Regulatory document collection for IRB submissions.

References Furnished Upon Request










Education:
· EDUCATION Boston University –Masters of Science in Project Management-October 2005-present
SUNY-Stony Brook-Stony Brook, NY September 1996- B.A., May 1999
Multidisciplinary Studies- concentrations in Biology and Health and Society
Woman Studies minor


Affiliations:
ACRP member (Association of Clinical Research Professional)


Skills:
· SKILLS
Microsoft Office (Word, Excel, PowerPoint, Project and Visio), Lotus Notes systems
Clinical Software Programs: SMS, Siebel, Co-path, Trial Manager, IMPACT, Remote Data
Capture (RDC), CORE (IVRS system), Oracle Clinical


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