Clinical Project Manager Resume

Desired Industry: Biotech	SpiderID: 15119
Desired Job Location: Edison, New Jersey	Date Posted: 8/27/2007
Type of Position: Contractor	Availability Date:
Desired Wage:
	U.S. Work Authorization: Yes
Job Level: Management (Manager, Director)	Willing to Travel: No
Highest Degree Attained: Doctoral	Willing to Relocate: No

Objective:
CONSULTING SERVICES
Pharmaceutical Development Services, LLC, Edison, NJ.
Consulting services (1099) for the Pharmaceutical, Biotechnology, and Medical Device, and Medical Equipment industries.
Management of all aspects (planning through database lock) of Phase III to IV multi-sites and IIT/IST clinical studies in accordance with FDA, ICH Regulations, company’s SOPs and guidelines.
Supervision of non-clinical and clinical projects from concept to post-approval.
Management of non-clinical and clinical research staff at sponsor, CRO, and site levels.
Management of global clinical studies –Australia, Europe and North America.
Languages - English/Spanish.

Experience:
CONSULTING SERVICES
Pharmaceutical Development Services, LLC, Edison, NJ.
Since January 2007
President

Consulting services (1099) for the Pharmaceutical, Biotechnology, and Medical Device, and Medical Equipment industries.
Management of all aspects (planning through database lock) of Phase III to IV multi-sites and IIT/IST clinical studies in accordance with FDA, ICH Regulations, company’s SOPs and guidelines.
Supervision of non-clinical and clinical projects from concept to post-approval.
Management of non-clinical and clinical research staff at sponsor, CRO, and site levels.
Management of global clinical studies –Australia, Europe and North America.
Languages - English/Spanish.

INDUSTRY CLIENTS
Adams Respiratory Therapeutics, Inc., Chester, NJ.
01/2007 – 05/2007
Consultant – Clinical Study Manager.
Managed CRO, vendors activities to conduct a Phase IV multi-sites (acute respiratory infection) clinical study. Managed CRO assigned project team for the successful planning and conduct of the challenging seasonal clinical study. Reviewed from the Sponsor side the study protocol, CRFs, patient diary and related study documents. Oversaw IRB submissions and approvals, site initiation, subject enrollment. Developed Sponsor TMF for the study. Liaised with KOLs, PIs, research and field staff to successfully complete patient enrollment on the clinical study - all in accordance with FDA, ICH Regulations, company’s SOPs and guidelines. Managed/monitored invoice payments vendors.

PROFESSIONAL EXPERIENCE
Domestic
Aerotek & Schering-Plough, Kenilworth, NJ.
10/2006 – 12/2006
Consultant.
Provided consulting – project management – services for client on a global (over 20 participating EU countries and Canada) Hepatitis C study. Implemented substantial improvements on the issuing of final study documents such as meeting minutes. Ensured proper study documents transmission and review process from participating countries to Central TMF.

UnitedHealth Group, Clinical Operations Manager.
06/2004 – 08/2006
Sanofi-Aventis, Contractor, Bridgewater, NJ.
Managed CRO, vendors activities to conduct large Phase IV respiratory (anti-infectives) clinical study. Managed, monitored all aspects of clinical studies including investigator/study site selection, investigator meeting planning and participation. Managed, monitored IRB submissions, approval, site initiation, subject enrollment, data retrieval and trial master file. Liaised with PIs, research and field staff to successfully complete clinical studies - all in accordance with FDA Regulations, company’s SOPs and guidelines. Developed study, vendor and site-specific budgets. Monitored grant, invoice payments to vendors and investigators. Reviewed, provided input to develop CRFs, guidelines and diaries. Managed eleven (11) double blind and open label IITs.

PROFESSIONAL EXPERIENCE (continuation):

Orion Pharma, Inc., Florham Park, NJ.
09/2002 – 06/2004
Senior Clinical Research Associate.
Managed CRO activities to conduct REVIVE - a Phase III, multicenter double-blind global clinical study on 700 CHF subjects – with more than 110 sites in the U.S., Australia, Israel and Canada. Reported, evaluated study progress – identified and recommended solutions to potential issues. Contributed to the timely data retrieval for REVIVE l and REVIVE ll. Ensured adherence to protocol, FDA regulations and ICH guidelines. Liaised with KOLs, PIs, clinical operations, data management and regulatory departments in the U.S., U.K and Finland. Evaluated study site feasibility, audit report and corrective action plan as well as regulatory documents submissions, IRB approval. Evaluated site initiation, interim and closeout visit reports.

Quintiles, Inc., Atlanta, GA.
09/2001 - 03/2002
Clinical Research Associate.
Monitored Alzheimer’s disease and Schizophrenia, Phase IV, multi center clinical studies using EDC (MetaTrial™). Ensured that assigned clinical sites, located in the Southeast of the U.S., complied with FDA regulations, ICH guidelines, company’s SOPs, and protocol specifications.

Kendle International, Inc., Cranford, NJ.
07/1998 - 10/1999
Clinical Research Associate.
Monitored: 1. Burn wounds, Phase IV multicenter comparative clinical study conducted in the U.S. & Canada for Westaim Biomedical Corporation’s Acticoat™, a silver-coated antimicrobial barrier dressing. 2. Osteoarthritis / rheumatoid arthritis, Phase III: multicenter clinical study in the U.S. for Searle Corporation.’s Celebrex® - celecoxib.

Ethicon, Inc., Somerville, NJ.
05/1994 - 01/1998
Assistant Scientist.
Developed models to evaluate and develop novel surgical products. Coordinated, performed
evaluations on medical devices and medical equipment on non-clinical phase. Coordinated, performed evaluations to develop metallic, absorbable and micro suture anchors, H-device for meniscus repair. Coordinated, performed evaluations to develop novel electrosurgical equipment for arthroscopy procedures. Tested to develop other surgical material and surgical devices.

Immunomedics, Inc., Newark, NJ.
10/1992 - 05/1994
Laboratory Animal Tech.
Conducted radiolabeled antibody biodistribution and therapy studies, testing of new compounds in non-clinical phase to discover drugs for the detection and treatment of colon cancer and lymphoma. Cultured and transplanted in-vitro and in-vivo colonies of lymphoma and colon - Daudi and LS-174T.

PROFESSIONAL EXPERIENCE (continuation):

International
Ministry of Agriculture, Santo Domingo, D.R. 1986 - 1989
Veterinary Doctor, Department of Animal Husbandry.
Monitored the health care and reproduction of imported swine and bovine herds. Instructed swine producers to improve animal production and health care practices. Produced - QA of rabies vaccines based on cell culture and brain of lactating mice.

Dominican Agrarian Institute, Santo Domingo, D.R. 1984 - 1986
Chairperson of the Animal Husbandry Division.
Supervised the Animal Assistance Division improving health care, production, physical facilities and associated economics of approximately 24 farms (dairy, beef feedlot, swine, and poultry). Established and maintained an Artificial Insemination program at nine (9) dairy farms.

Education:

EDUCATION
D.V.M., University Autonoma of Santo Domingo, Santo Domingo, D.R.
M.S., Animal Sciences, Swine Nutrition, University of Missouri, Columbia, MO.
Network Engineer, PCAge, Certified IT Career Institute, Edison, NJ.

GRADUATE RESEARCH
“Effect of Supplemental Yeast Culture in Sow Gestation and Lactation Diets on Apparent
Nutrient Digestibilities and Reproductive Performance Through One Reproductive Cycle"
- Master thesis, Journal of Animal Science, 1995, 73:1741-1745.
“Comparative Study of Natural Mating vs. Artificial Insemination in Dairy Cattle” - Doctoral thesis.

Affiliations:
PROFESSIONAL ORGANIZATION MEMBERSHIP
Association of Clinical Research Professionals.

Skills:
Management of clinical/preclinical studies.
Nutrition studies.
Animal medicine and surgery.
Animal production.
Bilingual: English/Spanish.

Additional Information:
TRAINING & CERTIFICATES
2004 - IMPACT - Study Manager’s Training, Aventis, Bridgewater, NJ.
2004 - Medical Affairs Project Planning (MAPPS-Project Server) Training, Aventis, Bridgewater, NJ.
2004 - Non-Clinical Requirements for the IND, Orion Pharma, Inc., Florham Park, NJ.
2004 - Clinical Study Management Sharing Forum, Orion Pharma, Inc., Helsinki, Finland.
2004 - Auditing Techniques for Clinical Research Professionals, Barnett International, Edison, NJ.
2003 - R&D Clinical Development Center Meeting, Orion Pharma, Inc., Helsinki, Finland.
2003 - REVIVE - Investigator Meeting, Orion Pharma, Inc./MDSPS, Chicago, IL.
2003 - REVIVE - Project Meeting, Orion Pharma, Inc./MDSPS, Irvine, CA.
2003 - Monitoring Clinical Drug Studies: Intermediate, Barnett International, Edison, NJ.
2003 - Sr. CRA/CRA Sharing, Orion Pharma, Inc., Helsinki, Finland.
2002 - MedDRA Coding Review and SAE Reconciliation, MDS PS, King of Prussia, PA.
2002 - Clinical Development Meeting, Orion Pharma, Inc., Helsinki, Finland.
2002 - Scientific Meeting, Heart Failure Society of America, Boca Raton, FL.
2001 - CORE Clinical Training, Quintiles, Inc., Research Triangle Park, NC.
2001 - Train the Trainer: An Information Session for Monitors, Research Triangle Park, NC.

TRAINING & CERTIFICATES (continuation):

2001 - Drug and Device Development, Quintiles, Inc., Atlanta, GA.
2001 - Good Clinical Practice (GCP), Quintiles, Inc., Atlanta, GA.
2001 - Clinical Fraud and Scientific Misconduct, Quintiles, Inc., Atlanta, GA.
2001 - MetaTrial™ Browser for the investigator Site, Quintiles, Atlanta, GA.
2001 - Human Participants Protection Education for Research Teams, NIH.
2001 - Drug Development Training System (DDTS), Quintiles, Inc., Atlanta, GA.
2001 - Excel 2000, New Horizons Computer Learning Center, Marietta, GA.
2000 - Certifications: MCSE (Windows NT), MCP+Internet, MCP, CNA, A+.
2000 - C.R. & Drug Development, Mercer County Community College, Trenton, NJ.
1998 - KORE - Research Excellence, Kendle College, Cincinnati, OH.
1989 - Training Session for Safe Use of Radioisotopes, University of Missouri, Columbia, MO.

PROFESSIONAL ORGANIZATION MEMBERSHIP
Association of Clinical Research Professionals.

Reference:
Available upon request.

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