Clinical Project Manager Resume
|Desired Industry: Biotech
|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
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.
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 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
ACRP member (Association of Clinical Research Professional)
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
Candidate Contact Information:
|JobSpider.com has chosen not to make contact information available on this page.
Click "Contact Candidate" to send this candidate a response.