Senior Clinical Research Professional - Biotech Resume Search
Senior Clinical Research Professional - Biotech Resume Search
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Senior Clinical Research Professional Resume

Desired Industry: Biotech SpiderID: 28134
Desired Job Location: Niantic, Connecticut Date Posted: 8/8/2009
Type of Position: Contractor Availability Date: 09/10/2009
Desired Wage: Open
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Doctoral Willing to Relocate: Yes

Provide Clinical Research / Affairs consulting services for the Biotechnology, Pharmaceutical, Medical Device, and CRO industries.


Pharmaceutical Development Services, LLC, Niantic, CT. 01/2007 – Present
• Provide consulting services: project management, clinical study management, domestic/international monitoring to fulfill business needs for the biotechnology, pharmaceutical, medical device, medical equipment and CRO industries.

Ximedica, LLC. Providence, RI. 09/2009 – 12/2009
Sr. Clinical Affairs Consultant
• Short term contract - Worked rigorously on the configuration, reorganization, duplication, and Verification of Trial Master File (TMF) corresponding to seven clinical studies for a Feminine Care device in development.
• Developed Consulting Services Report with effective recommendations for Inspection Readiness Plan, Risk Mitigation Plan, GCP Training, SOP Writing / Updates, TMF Configuration, Allocation of Time, Transfer of Study Documents.
• Conducted partial scientific literature search on the toxicity of a transdermal anesthetic in pediatrics.

PFIZER, INC., New London, CT. 2008 – 2009
Associate Director, Clinical Project Manager
• Oversaw the conduct of Phase 1 and 2 global clinical studies to ensure compliance with Federal, country, local regulations, company SOPs and guidelines within approved timelines and resources.
• Contributed successfully in the development of 3 study drugs and respective lifecycle: Phase 1 to Phase 2 under high degree of complexity.
• Developed overall project strategies; led cross–functional operational planning, conducted and completed multiple RA global clinical studies within programs alignment and resources while maintaining high degree of Quality Assurance.
• Oversaw and participated in study team operations and discussions covering all needs in the planning, execution, and closure of clinical studies.

Owner/ President
• Provide consulting – project management, clinical study management, monitoring – services that fulfill business needs for the biotechnology, pharmaceutical, medical device, medical equipment and CRO industries.

• Planned, implemented, and completed successfully a seasonal clinical study Phase IV acute respiratory infection clinical study conducted under very challenging timelines. Led the senior CRO project team selected to conduct the study.

AEROTEK & SCHERING–PLOUGH, Kenilworth, NJ. 2006 – 2006
• Coordinated and executed retrieval of regulatory packages and study data (Hepatitis C global Phase 4 clinical study) for global TMF from 20 plus countries that participated in a Hepatitis C global clinical study in a narrow timeframe.


UNITEDHEALTH GROUP, Bridgewater, NJ. 2004 – 2006
Clinical Operations Manager, Sanofi–Aventis, Contractor
• Provided quality consulting services to oversee contracted CRO and vendors’ activities that led to successful planning, conduct and completion of outsourced clinical studies and IITs.
• Managed 10 plus anti–infectives Investigator Initiated Trials (IITs) for Key Opinion Leaders (KOLs) from synopsis to report. Liaised with KOLs, PIs and research staff to ensure proper study conduct, collection of study data and issuing of study report.

ORION PHARMA, INC., Florham Park, NJ. 2002 – 2004
Senior Clinical Research Associate
• Supervised, co–monitored, and supported the administration and progress of REVIVE I and II clinical study – a CHF Phase 3, multi–center double–blind study in Australia, Canada, Israel, and the US.
• Wrote, implemented, coordinated, managed and executed the Motivational Site Visit Plan that led to increase in the enrollment of Subjects for this clinical study.

QUINTILES, INC., Atlanta, GA. 2001 – 2002
Clinical Research Associate
• Monitored: Alzheimer’s disease and Schizophrenia, Phase IV, multi–center clinical studies, using EDC (MetaTrial™) in the Southeast.
• Ensured clinical sites complied with FDA regulations, ICH guidelines, company’s SOPs and protocol.

KENDLE INTERNATIONAL, INC., Cranford, NJ. 1998 – 1999
Clinical Research Associate
• Contributed (monitored: a Phase IV, multi–center clinical study in the U.S. & Canada for Westaim Biomedical Corp.) in the submission for marketing approval for Acticoat™ – a burn wound dressing.
• Contributed in the monitoring role in the evaluation of Celebrex® – a RA Phase III (GI Events): multi–center clinical study in the U.S. for Searle Corporation.

ETHICON, INC., Somerville, NJ. 1994 – 1998
Assistant Scientist
• Managed numerous non–clinical projects: developed models to evaluate and develop novel surgical devices (metallic, absorbable and micro suture anchors, H–device for meniscus repair and arthroscopy procedures), electrosurgical instruments, and surgical equipment during non–clinical phase.
• Wrote protocols and study results for non–clinical projects to test and develop models for PANALOK which led to (510K) submission/approval.

IMMUNOMEDICS, INC., Newark, NJ. 1992 – 1994
Laboratory Animal Tech, Immuno–Oncology
• Conducted ~ 200 state–of–the–art (radio–labeled monoclonal antibodies (Immuno–Oncology / Early Drug Discovery) assays – biodistribution, MTDs, and therapy – to detect and treat small tumors: colon cancer and lymphoma.
• Cultured and transplanted in–vitro and in–vivo lymphoma and colon cells: Daudi and LS–174T.


MS, Animal Sciences, Swine Nutrition, University of Missouri, Columbia, MO.
DVM, University Autonoma of Santo Domingo, Santo Domingo, DR.
Network Engineer, PCAge, Certified IT Career Institute, Edison, NJ.


Association of Clinical Research Professionals.

Director / Senior Clinical Research Consultant with expertise in the development of global projects for the biotechnology, pharmaceutical, medical device, surgical / electrosurgical equipment, and CRO industries.

English & Spanish

• Team leader who drives the strategy, execution, and completion of global and domestic projects based on but not limited to historical data, risk mitigation, quality assurance, inspection readiness, and regulatory compliance.

• Successfully developed, conducted, and completed Inspection Readiness Plan for 20 plus global studies.

• Identified solutions to resolve subject enrollment issues during the conduct of global clinical studies leading to time reduction or completion within existing timelines.

• Planned and executed challenging clinical studies within projected timelines with exception of one study.

• Developed and managed rigorously study budgets from 10K to 16M to ensure completion of studies.

• Oversaw the planning and execution of four successful and well conducted face-to-face investigator meetings in Argentina, Czech Republic, and the US.

• Managed Sponsor and CRO project teams to implement and conduct an anti–infective upper respiratory clinical study Phase 4 Protocol designed to initiate 500 Sites and enroll 4000 Subjects.

• Reduced pre-clinical development of PANALOK from 1 ½ to 1 year in the planning, conduct, and completion the studies saving to the company a third in time, resources, and reduced 510K approval.

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